Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.

ABSTRACT:

Purpose

Nivolumab is a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC).

Patients and methods

Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety.

Result

SUBMITTER: Motzer RJ 

PROVIDER: S-EPMC4806782 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature