Study Comparing Datopotamab Deruxtecan with Standard Chemotherapy in Advanced Urothelial Cancer

Inclusion Criteria

• Adults aged 18 or older.
• Diagnosed with advanced urothelial cancer that cannot be removed by surgery or has spread to other parts of the body.
• Cancer must be primarily urothelial, even if there are other cell types present.
• Must not have certain types of cancer like urachal, small cell, or adenocarcinoma.
• If there is a history of prostate cancer, it must not be active or spreading.
• Must provide a tumor sample for testing.
• Eligible to receive chemotherapy with cisplatin or carboplatin.
• Cancer must have progressed after treatment with enfortumab vedotin and pembrolizumab.
• If previous treatment was stopped due to side effects, cancer must have progressed after stopping.
• Must not have received certain chemotherapy drugs within the last year if used for early-stage cancer.

Exclusion Criteria

• Previous treatment with systemic therapy other than enfortumab vedotin and pembrolizumab for advanced urothelial cancer.
• History of bone marrow or organ transplant.
• Currently taking medications not allowed in the study.
• Previous treatment with TROP2 directed therapy.
• Uncontrolled heart disease or recent heart attack.
• Severe lung disease or history of lung inflammation requiring steroids.
• Severe side effects from previous cancer treatments that have not improved.
• Certain chronic conditions related to previous cancer treatments, like stable nerve damage or hormone imbalances, may be allowed if they are well-managed.