NCT02256436

A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 542 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy will be randomly assigned to receive Investigator's choice of paclitaxel, docetaxel, or vinflunine (Control), or pembrolizumab. The primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.

Detailed description

For the purposes of this study, participants with a programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥10% were considered to have a strongly PD-L1 positive tumor status and participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. Effective with Amendment 15, eligible participants who are allocated to the Control arm (Investigator's Choice) and experience disease progression will be provided with the opportunity to switch over to receive pembrolizumab 200 mg one time every three weeks (Q3W) for up to two years of treatment.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	IV infusion
DRUG	paclitaxel	IV infusion
DRUG	vinflunine	IV infusion
DRUG	docetaxel	IV infusion

Timeline

• Start date: 2014-10-22
• Primary completion: 2016-09-07
• Completion: 2020-10-01
• First posted: 2014-10-03
• Last updated: 2021-09-20
• Results posted: 2017-08-31

Regulatory

• FDA-regulated drug study