A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

Exclusion Criteria

• •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• •Known active central nervous system metastases and/or carcinomatous meningitis.
• •Has Grade ≥2 peripheral neuropathy.
• •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
• •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease and/or serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
• •Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator.
• •Has a history of uncontrolled diabetes.
• •Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• •Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
• •PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
• •PART 2 ONLY: Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
• •Is human immunodeficiency virus (HIV)-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• •Has active Hepatitis B or Hepatitis C virus infection.
• •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• •Has an active infection requiring systemic therapy.
• •PART 2 ONLY: History of allogeneic tissue/solid organ transplant.
• •Has not adequately recovered from major surgery or has ongoing surgical complications.