A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive ladder Cancer
We are doing this study to learn more about if the combination of medications (durvalumab, tremelimumab and enfortumab vedotin)before and after bladder removal surgery will work and be safe for the treatment of muscle invasive bladder cancer. Also to better understand the disease and associated health problems.
In the main study, approximately 810 participants will be randomized in a 1:1:1 ratio to one of the following intervention groups to achieve 270 evaluable participants per arm in the main study.
-Neoadjuvant treatment for three 21-day cycles (ie, Neoadjuvant Weeks 1 through 9) with durvalumab 1500 mg (Day 1 of each cycle) +tremelimumab 75 mg (Cycle 1 Day 1 and Cycle 2 Day 8 only) + EV 1.25 mg/kg (Day 1 and Day 8 of each cycle)
- Radical cystectomy
- Adjuvant treatment for nine 28-day cycles (ie, Adjuvant Weeks 1 through 36) with durvalumab 1500 mg (Day 1 of each cycle) + tremelimumab 75 mg (Day 1 of first cycle only)
-Neoadjuvant treatment for three 21-day cycles (ie, Neoadjuvant Weeks 1 through 9) with durvalumab 1500 mg (Day 1 of each cycle) + EV 1.25 mg/kg (Day 1 and Day 8 of each cycle)
-Adjuvant treatment for nine 28-day cycles (ie, Adjuvant Weeks 1 through 36) with durvalumab 1500 mg (Day 1 of each cycle)
-No neoadjuvant treatment
-No adjuvant treatment
1) Participant must be 18 or older years at the time of screening
2) Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage of T2-4aN0-N1M0
3) Medically fit for cystectomy and able to receive neoadjuvant therapy
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