High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma

Phase 2 Terminated 6 enrolled Gregory Daniels

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this single arm phase 2 trial is to assess the response rate \[complete response (CR) + partial response (PR)\] of combined nivolumab and HD IL-2 in subjects with metastatic melanoma and renal cell carcinoma. Response will be performed after each course of nivolumab and IL-2 using RECIST 1.1. Patients will be treated for one course past best response for a maximum of 3 courses.

Timeline

Start: 2019-05-23
Primary completion: 2025-01-01
Completion: 2025-01-01

Outcome

Outcome not reported

Stopped (Business): “Lack of funding”

Publications

Azenkot T, Nikanjam M, Mhatre S, Mullen JT, Barkauskas DA, McKay RR, Baumgartner JM, Daniels GA. High dose interleukin-2 in combination with anti-programmed cell death protein 1 to overcome immune checkpoint inhibitor resistance in metastatic melanoma and renal cell carcinoma. Melanoma Res. 2026 Apr 30. doi: 10.1097/CMR.0000000000001102. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IL-2	Protein / enzyme biologic	—	—
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous