Stopped: Sponsor stopped the study after meeting enrollment targets and primary objectives, and after collecting sufficient data for planned regulatory filings. The decision was not due to safety concerns, futility, or any regulatory request.
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.
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Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Timeframe: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Timeframe: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
Timeframe: Up to 3 years
Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
Timeframe: Up to approximately 5 months