OncRef

Clinical Trial: NCT02853331

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-02-02

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).

The primary hypotheses of this study are:

  1. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  2. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).

Official Title

A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

Conditions

Renal Cell Carcinoma

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Axitinib
  • Drug: Sunitinib

Other Study ID Numbers

  • 3475-426
  • 163460
  • MK-3475-426
  • KEYNOTE-426
  • 2023-507294-18-00
  • U1111-1295-6836
  • 2016-000588-17
  • 2016
  • 2023

Start Date (Actual)

2016-09-16

Primary Completion Date (Actual)

2018-10-18

Study Completion Date (Actual)

2025-12-26

Enrollment (Actual)

861

Study Type

Interventional

Phase

Phase 3