Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-52)

Official Title

A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer

Summary:

This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants, in participants whose tumours rely on programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumours), and in participants with strongly PD-L1-positive tumours.

Trial Description

Primary Outcome:

• ORR by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) for All Participants (Independent Radiology Review)
• ORR by RECIST 1.1 for Participants with PD-L1-positive Tumours (Independent Radiology Review)
• ORR by RECIST 1.1 for Participants with Strongly PD-L1-positive Tumours (Independent Radiology Review)

Secondary Outcome:

• Duration of Response (DOR) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumours and Participants with Strongly PD-L1-positive Tumours (Independent Radiology Review)
• Progression-free Survival (PFS) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumours and Participants with Strongly PD-L1-positive Tumours (Independent Radiology Review)
• Overall Survival (OS) for All Participants, Participants with PD-L1-positive Tumours and Participants with Strongly PD-L1-positive Tumours

Participants receiving pembrolizumab who attain a complete response (CR) may consider stopping trial treatment if they meet criteria for holding therapy. Participants who stop trial treatment after receiving 24 months of trial treatment for reasons other than progressive disease (PD) or intolerability, or participants who attain a CR and stop trial treatment may be eligible for up to one year of retreatment upon experiencing PD.

View this trial on ClinicalTrials.gov