Trial Outcomes & Findings for Radiation and Combination Immunotherapy for Melanoma (NCT NCT03850691)

Last Updated: 2024-01-17

Results Overview

Determine the objective response rate (ORR). The ORR will be presented as the proportion of patients who achieved complete response (CR) or partial response (PR). In general, categorical data measurements will be summarized as counts and percentages (or proportions). The disease control rate (DCR) will be presented as the proportion of patients with CR, PR, or stable disease. The best overall response (BOR) will be measured as the maximum change from baseline in the sum of the longest diameter for each of the target lesions over the full 2 year follow-up period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

up to approximately 2 Years

Results posted on

2024-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Nivolumab Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Overall Study STARTED	1	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation and Combination Immunotherapy for Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Nivolumab n=1 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29	Total n=4 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	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 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	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to approximately 2 Years

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab n=1 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Objective Response Rate (ORR)	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Approximately up to 2 Years

This will be achieved by the number of adverse event (AE) reports. AEs, SAEs, deaths, and abnormal laboratory values will be summarized by the proportion of patients who experience them. Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All on-study AEs, Grade 3-4 AEs, treatment-related AEs, Grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs leading to discontinuation will be tabulated using the worst grade per NCI CTCAE v 5.0 criteria by system organ class.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab n=1 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Adverse Events)	3 Adverse events	0 Adverse events

PRIMARY outcome

Timeframe: Approximately up to 2 Years

This will be measured by the number of participants who are suspended from the trial as noted by a stopping rule event. These events are determined after serious adverse events are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The following events count toward an early stopping rule event: 1) Any Grade 2 or greater drug-related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 7 days of checkpoint inhibitor OR requires systemic treatment with corticosteroids, 2) Any Grade 3 or greater non-skin, drug-related adverse event lasting \> 7 days, including uveitis, pneumonitis, bronchospasm, diarrhea, colitis, neurologic toxicity, hypersensitivity reactions, and infusion reactions. In addition, the trial would be stopped and re-evaluated if there is ≥ 1 treatment-related mortality event.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab n=1 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 Participants Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of Stopping Rule Events)	0 Participants	0 Participants

Adverse Events

Cohort 1: Nivolumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort 2: Nivolumab & Ipilimumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Nivolumab n=1 participants at risk Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 participants at risk Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.	0.00% 0/3 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.
Metabolism and nutrition disorders Other	100.0% 1/1 • Number of events 1 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.	0.00% 0/3 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.

Other adverse events

Other adverse events
Measure	Cohort 1: Nivolumab n=1 participants at risk Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 1 (Cutaneous): Cycle 1: 6 Week Duration Nivolumab 240 mg IV Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29 Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15 Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study	Cohort 2: Nivolumab & Ipilimumab n=3 participants at risk Aldesleukin: All Patients: Cycle 1: (600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient. Days 1-5 and Days 15-19 (all patients) Nivolumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Nivolumab 1 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29. Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study Ipilimumab: Cohort 2 (Ocular): Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29 OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator: Ipilimumab 3 mg/kg IV on Day 29 Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29 Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.	0.00% 0/3 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.
Investigations Infections and infestations - Other, specify	100.0% 1/1 • Number of events 1 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.	0.00% 0/3 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.
Investigations Investigations - Other, specify	100.0% 1/1 • Number of events 1 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.	0.00% 0/3 • From first visit dose to end of trial visit (16 weeks if received all cycles). The end of trial visit date is approximately 4 weeks after the last dose of the study drug. Follow-up for disease status and survival will continue for up to 2 years from study enrollment by electronic/phone contact every 3 months (± 2 weeks) unless the patient withdraws consent. This gives an approximate timeline of up to 2 years, as the survival status at 2 years could potentially include death as an SAE.

Additional Information

Evidio Domingo-Musibay, MD

Masonic Cancer Center, University of Minnesota

Phone: 612-625-9604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place