NCT03297463

Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

A Phase 1b/2 Study of Hypofractionated Radiation and Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The sequential administration of Interleukin-2 (IL-2) following radiation therapy offers a rational immunologic priming strategy to expand antigen primed T cells under the growth promoting effects of Interleukin-2 therapy. This clinical trial is designed to evaluate the combination of the T cell cytokine Interleukin-2 and the checkpoint inhibitor Ipilimumab in sequential combination following a course of hypofractionated palliative radiation therapy. The addition of single dose Ipilimumab offers rational timing of CTLA-4 checkpoint blockade to decrease activity of regulatory and suppressor T cell subsets following IL-2 based immunotherapy.

Conditions

• Metastatic Melanoma
• Pulmonary Metastases
• Hepatic Metastases
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Interleukin-2 & Ipilimumab (P-Ib)	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.
DRUG	Interleukin-2 & Ipilimumab (P-II)	Phase II: \- Interleukin-2 \& Ipilimumab will be administered at the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D).

Timeline

• Start date: 2018-01-31
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-09-29
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study