drugset / Trial / NCT02796352

A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study

NCT02796352 ↗

Phase 2 Terminated 1 enrolled Ahmad Tarhini Prometheus Laboratories · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is for patients with advanced stage III or stage IV melanoma not adequately treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression on nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is also being done to look at the severity of side effects of IL-2 in patients. IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma.

Timeline

Start
2016-09
Primary completion
2017-02-16
Completion
2017-04

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 600000 iu/kg Intravenous

Indications