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Radiation and Combination Immunotherapy for Melanoma

NCT03850691 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-01-17

Study results available
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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

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

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Evidio Domingo-Musibay, MD · Division of Hematology, Oncology and Transplantation, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2021-05-04
Completion
2022-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03850691 on ClinicalTrials.gov