Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

Exclusion Criteria

• •Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
• •History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
• •Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.
• •* CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
• •* Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
• •History of or active autoimmune disease that has required systemic treatment in the past 2 years.
• •Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
• •Prior solid organ or bone marrow transplantation.
• •Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
• •Estimated life expectancy \<12 week
• •Prior treatment with an MMAE agent or anti-HER2 therapy