drugset / Trial / NCT03297463

Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

NCT03297463

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-01-31
Primary completion
2020-02-01
Completion
2020-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 0.1 mg/kg
Subject Ipilimumab Monoclonal antibody 0.3 mg/kg
Subject Ipilimumab Monoclonal antibody 1.5 mg/kg
Subject Ipilimumab Monoclonal antibody 3 mg/kg
Subject aldesleukin Protein / enzyme biologic