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
    Not Recruiting
  • End date
    Dec 28, 2025
  • participants needed
    950
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 April 2021
systemic therapy
carcinoma
metastasis
pembrolizumab
kidney tumor
nephrectomy
metastasectomy

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.

Description

Participants will be assigned to receive study treatment until disease recurrence, unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the participant, noncompliance with study treatment or procedural requirements, administrative reasons requiring cessation of treatment, or until the participant has received 17 cycles of study treatment (approximately 1 year). Each cycle is 3 weeks long.

Details
Condition Renal Cell Carcinoma
Treatment Pembrolizumab, Placebo (saline solution)
Clinical Study IdentifierNCT03142334
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 April 2021

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