Study on Pembrolizumab and Enfortumab Vedotin with Surgery for Muscle-Invasive Bladder Cancer in Patients Who Can't Use Cisplatin

Inclusion Criteria

• Diagnosed with muscle-invasive bladder cancer (MIBC) with a specific type of cancer cell structure.
• Cancer has not spread beyond the bladder area as confirmed by imaging.
• Eligible and willing to undergo surgery to remove the bladder and nearby lymph nodes.
• Cannot use cisplatin due to certain health conditions or choose not to use it.
• Have had a procedure to remove part of the bladder tumor for testing.
• Have a performance status score of 0, 1, or 2, indicating good overall health.
• Have adequate organ function based on medical tests.
• Male participants must agree to use contraception and not donate sperm during and after treatment.
• Female participants must not be pregnant or breastfeeding and agree to use effective contraception during and after treatment.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have another type of cancer that is progressing or required treatment within the last 3 years, with some exceptions.
• Cancer has spread to lymph nodes beyond a certain point or to other parts of the body.
• Have received previous treatments for bladder cancer, including chemotherapy or radiation.
• Have used certain immune therapies or investigational drugs within the last 3 years.
• Have had a partial bladder removal surgery.
• Have received a live vaccine within 30 days before starting the study.
• Are currently in another clinical trial or have used an investigational device recently.
• Have ongoing nerve damage or neuropathy.
• Have an immune deficiency or are on long-term steroid therapy.
• Have allergies to the study drugs or their components.
• Have active eye conditions like keratitis or corneal ulcers.
• Have an autoimmune disease requiring treatment in the past 2 years.
• Have uncontrolled diabetes or a history of lung inflammation requiring steroids.
• Have an active infection needing treatment.
• Have had a tissue or organ transplant.