Keynote Trials for Bladder Cancer

As the sponsor of the Keynote Oncology Clinical Trials, Merck is passionate about improving health. We are committed to accelerating every step in the journey in our quest to bring treatment options to people with cancer.

Below are trials currently being conducted in bladder cancer, evaluating the investigational study drug, pembrolizumab (MK-3475).

Active Clinical Trials

The cancer types listed below currently have active trial listings on clinicaltrials.gov. Click on a study name to be directed to that trial's information, or call 1-888-577-8839 to find a study site near you for the trial you are interested in.

MK-3475 Study for Urothelial Cancer

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

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

more about the study
Advanced Urothelial Cancer Trial

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

This is a study using pembrolizumab for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study hypothesis is that pembrolizumab treatment will result in a clinical meaningfully overall response rate (ORR) in participants whose tumors rely on programmed cell death ligand 1 (PD-L1) protein.

more about the study
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Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

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

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).

more about the study

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.