Study on Pembrolizumab for Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Must be 18 years or older.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have muscle-invasive bladder cancer that has not spread to lymph nodes or other parts of the body.
• Must have had a procedure to remove as much of the bladder tumor as possible within 60 days before starting the study.
• Must have enough tumor tissue available for testing.
• Must not be able to receive cisplatin-based chemotherapy or have chosen not to receive it.
• Must have adequate organ function based on specific blood tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use contraception.

Exclusion Criteria

• Have had chemotherapy for bladder cancer before.
• Have had another active cancer in the past 2 years, except for certain skin or prostate cancers.
• Have had radiation therapy for bladder cancer.
• Have an active infection requiring treatment.
• Have a history of Hepatitis B or C, unless resolved or controlled.
• Have a history of HIV infection.
• Have active tuberculosis.
• Are pregnant or breastfeeding.
• Have received certain immunotherapy drugs before.
• Have received a live vaccine within 30 days before starting the study.
• Have an immune deficiency or are on high-dose steroids or other immunosuppressive drugs.
• Have severe allergies to pembrolizumab.
• Have an autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung disease requiring steroids.
• Have any condition that might interfere with the study.
• Have had an organ transplant.
• Are currently in another clinical trial or have been in one recently.