Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)

Complete title: A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma

Research Study Number 20162614
 
Principal Investigator Evan Yu, MD
 
Phase III

Research Study Description

The purpose of this study is to determine the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma (bladder cancer).

The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in participants with programmed cell death ligand 1 (PD-L1) positive tumors and in all participants (includes those participants with PD-L1 positive tumors and those with PD-L1 negative tumors).

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 20162614
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Solid Tumors; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Urothelial Cancer; Immunotherapy; Carcinoma, Transitional Cell

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