OncRef

Clinical Trial: NCT03142334

Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-03-10

Study Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

Conditions

Renal Cell Carcinoma

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Placebo

Other Study ID Numbers

  • 3475-564
  • 173704
  • MK-3475-564
  • KEYNOTE-564
  • U1111-1275-8289
  • 2022-501251-81-00
  • 2016-004351-75
  • 2016

Start Date (Actual)

2017-06-09

Primary Completion Date (Actual)

2020-12-14

Study Completion Date (Actual)

2026-02-04

Enrollment (Actual)

994

Study Type

Interventional

Phase

Phase 3