Trial Outcomes & Findings for Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer (NCT NCT02595866)

Last Updated: 2024-08-09

Results Overview

Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

58 participants

Primary outcome timeframe

Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.

Results posted on

2024-08-09

Participant Flow

Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

Participant milestones

Participant milestones
Measure	Cohorts 1-3 (Pembrolizumab and cART) Participants enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy (cART) per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi Sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy (cART) per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Study STARTED	34	24
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	32	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohorts 1-3 (Pembrolizumab and cART) Participants enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy (cART) per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi Sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy (cART) per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Study Adverse Event	2	5
Overall Study Complicating Disease/Intercurrent Illness	1	1
Overall Study Death	0	1
Overall Study Incarceration	1	0
Overall Study Lack of Efficacy	17	7
Overall Study Physician Decision	4	3
Overall Study Switched to Alternative Treatment	1	0
Overall Study Study Terminated	0	4
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohorts 1-3 (Pembrolizumab and cART) n=34 Participants Participants enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort (n=12) was not sufficient to perform subgroup analysis based on a CD4 count Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 Participants Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=99 Participants	23 Participants n=107 Participants	51 Participants n=206 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants	1 Participants n=107 Participants	7 Participants n=206 Participants
Age, Continuous	56.2 years STANDARD_DEVIATION 9.3 • n=99 Participants	44.5 years STANDARD_DEVIATION 10.7 • n=107 Participants	51.3 years STANDARD_DEVIATION 11.4 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	30 Participants n=99 Participants	24 Participants n=107 Participants	54 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=99 Participants	19 Participants n=107 Participants	49 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants	10 Participants n=107 Participants	30 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	34 participants n=99 Participants	24 participants n=107 Participants	58 participants n=206 Participants
MK-3475 (Pembrolizumab) as First Systemic Therapy	26 Participants n=99 Participants	9 Participants n=107 Participants	35 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.

Population: Participants who received at least 1 dose of the study drug.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=10 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 Participants Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 Participants Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Frequency of Observed Adverse Events (AEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.

Population: Participants who received at least 1 dose of the study drug

This includes the occurrence of grade 2 or higher AEs. Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to combination antiretroviral therapy (cART). All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=10 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 Participants Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 Participants Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Incidence of Immune-related Events of Clinical Interest (irECI)	20.0 percentage of participants	50.0 percentage of participants	25.0 percentage of participants	20.8 percentage of participants	27.6 percentage of participants

PRIMARY outcome

Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.

Population: Participants who received at least 1 dose of the study drug.

Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to cART. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=10 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=12 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 Participants Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 Participants Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Incidence of cART-related ECIs of Grade 2 or Higher AEs	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Analysis is based on all participants who have received at least one dose of study treatment. Participants with missing outcomes considered nonresponders. Participants without progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Analyzed using Clopper-Pearson 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=34 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Objective Response Rate (Cohorts 1-3)	14.7 percentage of participants Interval 5.0 to 31.1	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 25 months

Population: All participants who receive at least one dose of study drug. Participants without documented progressive disease or death will be censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=34 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Progression-free Survival (Cohorts 1-3)	3.9 months Interval 2.8 to 4.8	—	—	—	—

SECONDARY outcome

Timeframe: Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years

Population: Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

Defined in participants experiencing CR or PR using RECIST 1.1, "Lugano Criteria" for malignant lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=34 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Duration of Response (Cohorts 1-3)	NA months Median duration of response (DOR) could not be calculated. Upper and lower confidence interval for DOR could not be obtained using Kaplan-Meier estimates. Insufficient number of participants with events.	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug to death due to any cause, assessed up to 3 years

Population: Participants who receive at least one dose of study drug. Participants without documented death at the time of analysis were censored at the date last known to be alive. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=34 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Survival (Cohorts 1-3)	14.5 months Interval 11.5 to 21.3	—	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Defined as the proportion of participants who achieved the best objective response rate (complete response (CR) + partial response (PR)) as determined by modified Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) criteria Analyzed using Clopper-Pearson 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=29 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=8 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=21 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Objective Response Rate (Partial Response + Completion Response)(Kaposi Sarcoma Cohort)	62.1 percentage of participants Interval 42.3 to 79.3	87.5 percentage of participants Interval 47.3 to 99.7	52.4 percentage of participants Interval 29.8 to 74.3	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 3 years

Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=29 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=8 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=21 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Progression-free Survival (Kaposi Sarcoma Cohort)	28.2 months Interval 4.2 to Upper confidence interval for PFS could not be obtained based on Kaplan-Meier estimates. Insufficient number of participants with events.	28.2 months Interval 3.3 to Upper confidence interval for PFS could not be obtained based on Kaplan-Meier estimates. Insufficient number of participants with events.	NA months Interval 2.8 to Median PFS could not be calculated and upper confidence interval was not obtained based on Kaplan-Meier estimates. Insufficient number of participants with events.	—	—

SECONDARY outcome

Timeframe: Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years

Population: Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date.

Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=29 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=8 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=21 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Duration of Response (Kaposi Sarcoma Cohort)	NA months Median for duration of response (DOR) was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	NA months Interval 3.5 to Median for duration of response (DOR) was not calculated. Upper confidence interval for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	NA months Median for duration of response was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug to death due to any cause, assessed up to 3 years

Population: Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date.

Summarized statistically using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort 1 (Pembrolizumab and cART) n=32 Participants Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=9 Participants Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=23 Participants Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Survival (Kaposi Sarcoma Cohort)	NA months Interval 28.2 to Median survival time could not be calculated and upper limit for the confidence interval were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	NA months Interval 28.2 to Median survival time could not be calculated and upper limit for the confidence interval were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	NA months Interval 17.2 to Median survival time could not be calculated and upper limit for the confidence interval were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.	—	—

Adverse Events

Cohort 1 (Pembrolizumab and cART)

Serious events: 8 serious events

Other events: 10 other events

Deaths: 5 deaths

Cohort 2 (Pembrolizumab and cART)

Serious events: 8 serious events

Other events: 12 other events

Deaths: 5 deaths

Cohort 3 (Pembrolizumab and cART)

Serious events: 6 serious events

Other events: 12 other events

Deaths: 5 deaths

Cohort 4 (Pembrolizumab and cART)

Serious events: 9 serious events

Other events: 24 other events

Deaths: 2 deaths

Total

Serious events: 31 serious events

Other events: 58 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 (Pembrolizumab and cART) n=10 participants at risk Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=12 participants at risk Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=12 participants at risk Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 participants at risk Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 participants at risk Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Blood and lymphatic system disorders Anemia	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Blood and lymphatic system disorders Febrile Neutropenia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Blood and lymphatic system disorders Hemolysis	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Blood and lymphatic system disorders Leukocytosis	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Cardiac disorders Cardiac arrest	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Cardiac disorders Sinus tachycardia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Cardiac disorders Myocardial infarction	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Eye disorders Retinal detachment	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Diarrhea	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Nausea	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Pancreatitis	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Bronchopulmonary hemorrhage - hemoptisis	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Death NOS	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Edema limbs	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Edema trunk	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Failure to thrive	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Fever	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Localized edema	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Non-cardiac chest pain	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Pain	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Pulmonary embolism - thromboembolic event	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Eye infection	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Lung infection	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Mycobacterium avium complex	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Skin infection	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Soft tissue infection	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Urinary tract infection	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Creatinine increased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Lymphocyte count decreased	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Platelet count decreased	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hypercalcemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hypokalemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hyponatremia	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Hypophosphatemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to progressive disease	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic anal carcinoma	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer progressive disease	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Psychiatric disorders Other, Disposition Issue	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Acute kidney injury	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Proteinurea	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Urinary frequency	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Urinary retention	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	1.7% 1/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Vascular disorders Hypotension	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Vascular disorders Thromboembolic event	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	3.4% 2/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.

Other adverse events

Other adverse events
Measure	Cohort 1 (Pembrolizumab and cART) n=10 participants at risk Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 2 (Pembrolizumab and cART) n=12 participants at risk Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 3 (Pembrolizumab and cART) n=12 participants at risk Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Cohort 4 (Pembrolizumab and cART) n=24 participants at risk Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT	Total n=58 participants at risk Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
Blood and lymphatic system disorders Anemia	50.0% 5/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	83.3% 10/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	58.3% 7/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	45.8% 11/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	56.9% 33/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Cardiac disorders Sinus tachycardia	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Endocrine disorders Hypothyroidism	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Eye disorders Blurred vision	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Eye disorders Dry eye	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Abdominal pain	40.0% 4/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	19.0% 11/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Bloating	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Constipation	50.0% 5/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.8% 5/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.3% 17/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.8% 5/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Nausea	50.0% 5/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.2% 7/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	32.8% 19/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	19.0% 11/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Chills	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Blood and lymphatic system disorders Edema limbs	50.0% 5/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Fatigue	60.0% 6/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	75.0% 9/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 6/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	37.5% 9/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	51.7% 30/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Fever	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Night sweats	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Non-cardiac chest pain	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
General disorders Pain	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.8% 5/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	22.4% 13/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Upper respiratory infection	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Infections and infestations Urinary tract infection	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	24.1% 14/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Alkaline phosphatase increased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 6/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	22.4% 13/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.2% 7/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	31.0% 18/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Blood bilirubin increased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	15.5% 9/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations CD4 lymphocytes decreased	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 6/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.8% 5/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.3% 17/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations CPK increased	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	62.5% 15/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	36.2% 21/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Creatinine increased	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 6/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 8/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	31.0% 18/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Lymphocyte count decreased	60.0% 6/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	75.0% 9/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 10/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	48.3% 28/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Neutrophil count decreased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 6/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.7% 12/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Platelet count decreased	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	17.2% 10/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Weight loss	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations White blood cell decreased	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.2% 7/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.3% 17/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Metabolism and nutrition disorders Anorexia	50.0% 5/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	24.1% 14/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypercalcemia	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hyperglycemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	37.5% 9/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	29.3% 17/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hyperkalemia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypoalbuminemia	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	24.1% 14/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypocalcemia	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypokalemia	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 6/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.7% 12/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypomagnesemia	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hyponatremia	40.0% 4/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 6/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	50.0% 12/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	44.8% 26/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Investigations Hypophosphatemia	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 6/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.9% 15/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.7% 12/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Nervous system disorders Dizziness	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Nervous system disorders Headache	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 6/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	20.7% 12/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Psychiatric disorders Anxiety	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Psychiatric disorders Depression	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Psychiatric disorders Insomnia	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Hematuria	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Renal and urinary disorders Proteinurea	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	41.7% 5/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	19.0% 11/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	13.8% 8/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	5.2% 3/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.1% 7/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	4.2% 1/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	6.9% 4/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	25.0% 3/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	0.00% 0/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	10.3% 6/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.0% 1/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 2/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.6% 5/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	8.3% 1/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	12.5% 3/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	17.2% 10/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
Skin and subcutaneous tissue disorders Rash maculo-papular	30.0% 3/10 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 2/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	33.3% 4/12 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	16.7% 4/24 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.	22.4% 13/58 • Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months. Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.

Additional Information

Kathryn Lurain, M.D.

HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute

Phone: 240-858-3257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60