Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

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)

Complete title: A Phase III, 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)

Research Study Number 20171511
 
Principal Investigator Scott Tykodi, MD
 
Phase III

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20171511
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Kidney Cancer; Renal Cancer; Solid Tumors; Urogenital Neoplasms; Urologic Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Renal Cell

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