Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor: Masonic Cancer Center, University of Minnesota
Study ID: NCT03297463
Phase: PHASE1/PHASE2
Status: Withdrawn

Conditions

Brain Metastases
Hepatic Metastases
Metastatic Melanoma
Pulmonary Metastases

Eligibility Criteria

Sex: ALL
Age: 18 Years - 85 Years
Healthy Volunteers: Not accepted

Interventions

Interleukin-2 & Ipilimumab (P-Ib) — DRUG
Phase Ib: \- Ipilimumab will be administered in a 3 + 3 dose escalation design. * The starting dose will be 0.3 mg/kg administered within 7 days of day 1 cycle 2 ALdesleukin (IL-2). * If dose limiting autoimmune toxicities (DLTs) are not observed, the next cohort will receive 1.5 mg/kg. * The final cohort will receive 3 mg/kg, in the event that cohort 2 does not exhibit DLTs. * In the event of excessive toxicity in cohort 1, then a -1 dose level of 0.1 mg/kg may be evaluated in subsequent cohorts. Cohort sizes will increase to 6 patients if 1 of 3 patients in a cohort experience a DLT. * Once the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) is declared, no staggering of enrollment is required for accrual.
Interleukin-2 & Ipilimumab (P-II) — DRUG
Phase II: \- Interleukin-2 \& Ipilimumab will be administered at the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D).

Study Details

This is a Phase 1b/2 study designed to evaluate combination of the human T-cell cytokine Interleukin-2 (IL-2) and a checkpoint inhibitor Ipilimumab immediately following a course of hypofractionated palliative radiation therapy in the management of unresectable, relapsed/refractory metastatic melanoma.