Trial Outcomes & Findings for Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma (NCT NCT03061188)

Last Updated: 2024-06-12

Results Overview

The MTD will be defined as the highest dose that causes dose-limiting toxicities (DLTs) in \<2 of 6 patients. Toxicity will be assessed using CTCAEv4.03. A DLT is defined as an Adverse Event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days (1 cycle) following the first dose of veliparib and nivolumab and meets any of the following criteria: Grade ≥ 3 non-hematologic toxicities that represent at least a 2-grade increase from baseline excluding Nausea, vomiting, diarrhea lasting ≤48 hours, Electrolyte abnormalities resolving within ≤24 hours, Hypersensitivity reactions,and Alopecia. Grade 4 thrombocytopenia (platelets \< 25.0 x 109 /L) Grade 3 thrombocytopenia with bleeding (platelets \< 0.5 x 109 /L) 5. Grade 3 febrile neutropenia with fever lasting for \> 7 days 6. Grade 4 febrile neutropenia of any duration 7. Dosing delay due to toxicity for \> 14 consecutive days from the date nivolumab or veliparib is due.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

First Cycle of Treatment with velaparib and nivolumab (28 days)

Results posted on

2024-06-12

Participant Flow

Opened for accrual on May 23, 2017 with goal of 50 patients. Due to funding issues the goal was reduced to 15. First patient started treatment June 1, 2017. Study design for Phase 1 was 3 + 3 escalation. The study closed Aug. 5, 2019 with accrual for the study design having been met.

Participant milestones

Participant milestones
Measure	Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab) Patients receive veliparib 300 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Completed 1st Cycle STARTED	3	6	6
Completed 1st Cycle COMPLETED	3	6	6
Completed 1st Cycle NOT COMPLETED	0	0	0
Went on to Cycle 2 and Beyond STARTED	3	6	6
Went on to Cycle 2 and Beyond Received Dose of Study Drugs	3	5	5
Went on to Cycle 2 and Beyond COMPLETED	3	5	5
Went on to Cycle 2 and Beyond NOT COMPLETED	0	1	1
On Follow-up for 3 Years STARTED	3	6	6
On Follow-up for 3 Years COMPLETED	0	1	1
On Follow-up for 3 Years NOT COMPLETED	3	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab) Patients receive veliparib 300 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Went on to Cycle 2 and Beyond Adverse Event	0	1	1
On Follow-up for 3 Years Death	3	5	4
On Follow-up for 3 Years Withdrawal by Subject	0	0	1

Baseline Characteristics

Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velaparib PO Twice Daily + Nivolumab (Cohort -1) Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Velaparib dose in Phase 1: Cohort -1: 200mg * Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 \& 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Velaparib PO Twice Daily + Nivolumab (Cohort 1) n=3 Participants Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Velaparib dose in Phase 1: Cohort 1: 300 mg, * Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 \& 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Velaparib PO Twice Daily + Nivolumab (Cohort 2) n=6 Participants Velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Velaparib dose: 400 mg * Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 \& 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Velaparib PO Twice Daily + Nivolumab (Phase 2) n=6 Participants Patients in all Phase 1 cohorts and Phase 2 receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Velaparib dose 400 mg * Nivolumab dose: Cycle 1-4: 240 mg IV every 14 days (Days 1 \& 15) + Cycle 5+: 480mg IV every 28 days (Day 1) Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Total n=15 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	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants	4 Participants n=7 Participants	11 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	8 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	1 Participants n=7 Participants	7 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=7 Participants	14 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	3 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants	4 Participants n=7 Participants	12 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Region of Enrollment United States	—	3 participants n=107 Participants	6 participants n=206 Participants	6 participants n=7 Participants	15 participants n=31 Participants
Mutation in DNA repair gene present Yes	—	1 participants n=107 Participants	3 participants n=206 Participants	5 participants n=7 Participants	9 participants n=31 Participants
Mutation in DNA repair gene present No	—	2 participants n=107 Participants	3 participants n=206 Participants	1 participants n=7 Participants	6 participants n=31 Participants
Lymphoma vs Solid Tumor Lymphoma	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Lymphoma vs Solid Tumor Solid Tumor	0 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	15 Participants n=31 Participants

PRIMARY outcome

Timeframe: First Cycle of Treatment with velaparib and nivolumab (28 days)

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=9 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Maximum Tolerated Dose (MTD)	400 mg	—	—

SECONDARY outcome

Timeframe: Up to 30 days after treatment discontinuation, where 1 cycle =28 days, and range of cycles is 1-12.

Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Hyponatremia	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Alkaline phosphatase increased	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Anemia	1 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 4 Anemia	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Platelet count decreased	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Fatigue	0 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Hypokalemia	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Hypertension	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Aspartate aminotransferase increased	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5 Grade 3 Alanine aminotransferase increased	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: after 2 cycles at first response time point (1 cycle = 28 days)

Overall response rate or ORR, (partial response (PR) + complete response (CR)) will be evaluated using RECIST criteria v1.1 or Lugano 2014 classification for assessment of Lymphoma. Per RECIST v. 1.1: PR= : At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Per Lugano 2014 classification, scored on a Deauville 5-point scale (an internationally-recommended scale using FDG PET-CT in the initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). * Partial metabolic response (PMR): score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. * Complete metabolic response (CMR): Score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
ORR (Overall Response Rate) Complete Response	0 participants	0 participants	0 participants
ORR (Overall Response Rate) Partial Response	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From the start of treatment and every 2 cycles during treatment where 1 cycle =28 days, average number of cycles is 4 and range of cycles is 1-12.

CBR= stable disease for ≥12 weeks + Partial Response + Complete Response per RECIST v1.1 for solid tumors or Lugano 2014 classification for lymphomas. Lugano scored on a Deauville 5-point scale. RECIST v. 1.1: PR= : At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Lugano 2014 classification: PR: score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. CR: Score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass. SD: No metabolic response, Score 4 or 5 with no significant change in FDG uptake from baseline at interim or end of treatment.

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab n=6 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Clinical Benefit Rate (CBR) Complete Response	0 participants	0 participants	0 participants
Clinical Benefit Rate (CBR) Partial Response	0 participants	0 participants	0 participants
Clinical Benefit Rate (CBR) Stable Disease for or ≥12 weeks	0 participants	4 participants	2 participants

SECONDARY outcome

Timeframe: From the start of treatment and every 2 cycles during treatment, and up to three years, where 1 cycle =28 days, and range of cycles is 1-12.

To evaluate Progression Free Survival (PFS) for patients treated with nivolumab and veliparib, defined as the time from treatment initiation to documented disease progression. Evaluated by RECIST criteria v1.1 for solid tumors or Lugano 2014 classification for assessment of Lymphoma. RECIST v. 1.1 definition for PD (Progressive disease): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Lugano 2014 classification, scored on a Deauville 5-point scale (an internationally-recommended scale using FDG PET-CT in the initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). Per Lugano criteria: Partial metabolic disease (PMD):Score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=11 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Progression Free Survival (PFS)	2.07 months Interval 2.0 to The upper limit of the confidence interval would be outside of the limits of the observed values and thus cannot be reported.	1.94 months Interval 1.77 to The upper limit of the confidence interval would be outside of the limits of the observed values and thus cannot be reported.	—

SECONDARY outcome

Timeframe: From the start of treatment and up to 3 years, where 1 cycle =28 days, and range of cycles is 1-12.

Overall Survival is defined as the time from treatment initiation until death due to any cause, assessed up to 3 years from the start of treatment.

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=12 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Overall Survival (OS)	5.82 months Interval 4.73 to 95% UCL for median survival was calculated by finding the smallest observed death time whose upper 95% CI was just above 0.5. but no observed death time met this criteria.	11.79 months Interval 6.18 to 95% UCL for median survival was calculated by finding the smallest observed death time whose upper 95% CI was just above 0.5. but no observed death time met this criteria.	—

SECONDARY outcome

Timeframe: At 24 weeks

Population: 2 patients not included in these results as they came off treatment before 24 weeks - one withdrew consent and 1 came off treatment for palliative radiation.

To evaluate the number of patients alive and progression free at 24 weeks. -Per RECIST v. 1.1 (for solid tumors) progression is defined as : At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) -Lugano 2014 classification, scored on a Deauville 5-point scale (an internationally-recommended scale using FDG PET-CT in the initial staging and assessment of treatment response i Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). Per Lugano criteria: Partial metabolic disease (PMD):Score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

Outcome measures

Outcome measures
Measure	Velaparib PO Twice Daily + Nivolumab (Phase 1) n=3 Participants Patients in all Phase 1 cohorts receive velaparib (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \*Velaparib dose in Phase 1: Cohort -1: 200mg, Cohort 1: 300 mg, Cohort 2: 400 mg Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=5 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab n=5 Participants Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Number of Patients Alive and Progression Free at 24 Weeks	0 participants	1 participants	2 participants

Adverse Events

Phase 1:Cohort-1 (Velaparib 200 mg PO Twice Daily + Nivolumab)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab)

Serious events: 6 serious events

Other events: 6 other events

Deaths: 6 deaths

Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1:Cohort-1 (Velaparib 200 mg PO Twice Daily + Nivolumab) Patients receive veliparib 200 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 1 (Velaparib 300 mg PO Twice Daily + Nivolumab) n=3 participants at risk Patients receive veliparib 300 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 1:Cohort 2 (Velaparib 400 mg PO Twice Daily + Nivolumab) n=6 participants at risk Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO	Phase 2 MTD: Velaparib 400 mg PO Twice Daily + Nivolumab n=6 participants at risk Patients receive veliparib 400 mg (oral medication) twice daily and nivolumab IV over 30 minutes on days 1 and 15 of courses 1-4 and IV over 60 minutes on day 1 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pharmacological Study: Correlative studies Veliparib: Given PO
Infections and infestations Sepsis	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	66.7% 2/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	50.0% 3/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Hepatobiliary disorders Hepatobiliary disorder - Other:Cholangitis	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	33.3% 1/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	50.0% 3/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
General disorders Fever	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	66.7% 2/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Gastrointestinal disorders GI bleed	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	33.3% 1/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Infections and infestations Hepatic Infection	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	33.3% 1/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Gastrointestinal disorders Gastric outlet obstruction	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	33.3% 1/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Cardiac disorders Pericarditis	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Gastrointestinal disorders Gastric Hemorrhage	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Cardiac disorders Cardiac Arrest	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Gastrointestinal disorders Abdominal pain	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Nervous system disorders Movements Involuntary	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Gastrointestinal disorders Diarrhea	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	— 0/0 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 3 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment, where 1 Cycle = 28 days the range of cycles attempted was 1-12. The starting dose was Cohort level 1. There were no dose-limiting toxicities on Cohort 1 so the dose was never de-escalated, Cohort -1 never opened to enrollment.

Other adverse events

Additional Information

Young Kwang Chae, MD, MPH, MBA

Northwestern University, Feinberg School of Medicine

Phone: 312-926-4248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place