Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer

Phase 2 Completed 27 enrolled H. Lee Moffitt Cancer Center and Research Institute Merck Sharp & Dohme LLC · collab Prometheus Laboratories · collab

NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab. Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™. Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.

Timeline

Start: 2017-04-25
Primary completion: 2019-03-26
Completion: 2025-10-30

Outcome

Met primary endpoint

paper The study met its primary endpoint with an overall response rate exceeding the pre-specified threshold of 45%. PMID 42185255 ↗

Publications

Johnson JS, Miller JW, Hatoum F, Schell MJ, Yu X, Roman Souza G, Mizelle S, Gullapalli K, Fazili A, Jain R, Chatzkel J, Cen L, Dhillon J, Cubitt C, Yao J, Whiting J, Li J, Swank J, Jameel G, Zhang J, Wang X, Spiess PE, Fishman M, Chahoud J. Pembrolizumab plus high-dose IL-2 in advanced clear cell renal cell carcinoma: six-year survival outcomes and molecular signatures from a phase 2 trial. Nat Commun. 2026 May 25. doi: 10.1038/s41467-026-73336-1. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	aldesleukin	Protein / enzyme biologic	600000 iu/kg	Intravenous