NCT03850691

Radiation and Combination Immunotherapy for Melanoma

A Phase 2 Study of Palliative Radiation and Combination Sequential Immunotherapy for Metastatic Cutaneous Melanoma and Ocular Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study designed to evaluate the combination of checkpoint blockade and aldesleukin (IL-2) therapy after a course of standard of care palliative radiation in the management of unresectable metastatic melanoma. To be eligible, a patient must have a minimum of 3 (preferably \>5) radiographically distinct, measurable (\>1.5 cm) lesions based on RECIST 1.1. Metastatic cutaneous melanoma must be refractory to standard immunotherapy drugs, molecular targeted agents and/or chemotherapy. Patients with ocular melanoma subtypes may enroll in this study without prior therapy, as there is no standard front-line therapy for this subset of patients.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-28
• Primary completion: 2021-05-04
• Completion: 2022-12-12
• First posted: 2019-02-22
• Last updated: 2024-01-17
• Results posted: 2023-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study