KEYNOTE-045

Automated from the 30 newest of 35 indexed sources (May 2017 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.

• Whether PD-L1 can predict pembrolizumab benefit
• Whether pembrolizumab retreatment is appropriate after prior benefit
• Which subsequent treatments to consider after pembrolizumab

Official title

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

Phase

Phase 3

Status

Completed

Conditions

Urothelial Cancer

Interventions

pembrolizumab; paclitaxel; vinflunine; docetaxel

Arms

• Control · Active comparator
• Pembrolizumab · Experimental

Enrollment

542

Primary outcomes

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants
• Overall Survival (OS) - All Participants
• PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors
• OS - Participants With PD-L1 Positive Tumors
• PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors
• OS - Participants With Strongly PD-L1 Positive Tumors

Sponsor

Merck Sharp & Dohme LLC

Start

Oct 22, 2014

Primary completion

Sep 7, 2016

Results posted

Yes

Registry record

NCT02256436 · updated Sep 20, 2021

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