Study on Enfortumab Vedotin and Pembrolizumab with Bladder-Sparing Approach for Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Must provide written consent and agree to share health information.
• Be 18 years or older.
• Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
• Have muscle-invasive bladder cancer that has not spread to other parts of the body.
• Have had a recent procedure to remove as much of the bladder tumor as possible.
• Have enough tumor tissue available for testing.
• Be eligible for bladder removal surgery if needed.
• 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 if sexually active with women of childbearing potential.

Exclusion Criteria

• Have nerve damage or other significant side effects from previous treatments.
• Have had previous chemotherapy or radiation for bladder cancer.
• Have another active cancer within the last two years, except for certain low-risk cancers.
• Have uncontrolled diabetes or active infections.
• Have active hepatitis B or C, or tuberculosis.
• Be pregnant or breastfeeding.
• Have received certain immune therapies or vaccines recently.
• Have a history of severe allergic reactions to the study drugs.
• Have an autoimmune disease requiring treatment in the past two years.
• Have lung disease or other conditions that could interfere with the study.
• Have had an organ transplant.
• Be participating in another clinical trial or using investigational treatments.