Radiation and Combination Immunotherapy for Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

May 4, 2021

Study Completion Date

December 12, 2022

Conditions
Metastatic Melanoma
Interventions
DRUG

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)"

DRUG

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"

DRUG

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"

DRUG

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"

Trial Locations (1)

55337

University of Minnesota Masonic Cancer Center, Burnsville

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT03850691 - Radiation and Combination Immunotherapy for Melanoma | Biotech Hunter | Biotech Hunter