IRB #

STUDY00019408

Title

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to test the safety of the study drugs, pembrolizumab/MK-3475 in combination with Bacillus Calmette-Guerin (BCG) and see how well pembrolizumab in combination with BCG works compared to BCG alone.

Medical Condition(s)

High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that has continued or returned following BCG induction.

Eligibility Criteria

Must have a confirmed diagnosis of bladder cancer, must have been treated with one course of BCG induction therapy and have persistent or recurrent cancer. Must have also undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Up to five years

Minors Included

No

Contact

Email: trials@ohsu.edu

Phone: 503-494-1080

Sponsor

Merck Sharp & Dohme Corp

Recruitment End

02/01/2022

Compensation Provided

No


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