Study on Pembrolizumab and Enfortumab Vedotin with or without Additional Investigational Drugs for First-Line Treatment of Metastatic Urothelial Carcinoma

Inclusion Criteria

• Must have advanced or metastatic urothelial carcinoma confirmed by lab tests.
• If the cancer has mixed cell types, at least 50% must be urothelial cells.
• Cannot have any neuroendocrine cancer cell types.
• Must not have received prior systemic therapy for advanced urothelial carcinoma, but previous chemotherapy for earlier stages is allowed.
• Must provide a tumor sample for testing, preferably a new biopsy.
• Any side effects from previous cancer treatments must have improved to mild levels or returned to baseline.

Exclusion Criteria

• Cannot have another active cancer unless it was treated successfully and has not returned for at least 3 years.
• If cancer has spread to the brain, it must be stable for at least 4 weeks, with no new growth, and the patient must be on a low dose of steroids if needed.
• Cannot have received a live vaccine within 30 days before starting the study.
• Cannot have used experimental treatments or devices within 4 weeks before starting the study.
• Cannot have immune system deficiencies or be on long-term steroid or immunosuppressive therapy, except for certain conditions.
• Cannot have active eye infections or ulcers unless they are being treated effectively.
• Cannot have an active autoimmune disease needing treatment in the past 2 years, except for hormone replacement.
• Cannot have uncontrolled diabetes.
• Cannot have a history of lung inflammation needing steroids or current lung inflammation.
• Cannot have an active infection needing treatment.
• Cannot have HIV, hepatitis B, or hepatitis C.
• Cannot have had major surgery within 4 weeks before starting the study.
• Cannot have had a tissue or organ transplant.