Phase 3 Study Comparing 9MW2821 with Toripalimab to Standard Chemotherapy for First Treatment of Advanced or Metastatic Urothelial Cancer

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and immune response of a combination treatment of 9MW2821 and Toripalimab compared to standard chemotherapy for adults with locally advanced or metastatic urothelial cancer who have not had prior systemic treatment. This phase 3 randomized, controlled, open-label study involves multiple centers and aims to provide new options for this serious condition. Participants will be randomly assigned to receive either the experimental combination of 9MW2821 at 1.25 mgkg and Toripalimab at 240 mg, both given by intravenous infusion, or standard chemotherapy consisting of Gemcitabine with either Cisplatin or Carboplatin, also given by intravenous infusion. The study includes two treatment groups and is designed to compare these approaches as first-line therapy. During the study, participants will undergo regular assessments including imaging to measure tumor response using criteria up to 50 months, overall survival tracking, and evaluations of side effects and immune responses. Researchers will monitor progression-free survival and other outcomes, along with safety and tolerability. Follow-up visits and evaluations will be conducted throughout the study period to gather comprehensive data on the treatments impact and participant health.

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer