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

Official 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


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 tumours (Combined Positive Score [CPS] ≥10%) and in all participants (includes those participants with PD-L1 positive tumours and those with PD-L1 negative tumours [CPS <10%]).

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) Using Response Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
  • Overall Survival (OS)
Secondary Outcome:
  • Number of Participants Who Experience an Adverse Event (AE)
  • Number of Participants Who Discontinue Study Drug Due to an AE
  • Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR
  • Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR
  • PFS Using RECIST 1.1 as Assessed by BICR at Milestone Timepoints
  • Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR
  • Change from Baseline in Health-related Quality of Life Score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

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Canadian Cancer Society

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