Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin (VOLGA)
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin (VOLGA)
Brief Summary:
A Global 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 Bladder Cancer
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Bladder Cancer
Actual Study Start Date: August 5, 2021
Estimated Primary Completion Date: July 18, 2025
Estimated Study Completion Date: September 8, 2028
Arm:
- Experimental: Durvalumab + Tremelimumab + Enfortumab vedotin
- Experimental: Durvalumab + Enfortumab vedotin
- Active Comparator: Straight to cystectomy
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 830 |
| Actual Study start date | 05 August 2021 |
| Estimated Study Completion Date | 08 September 2028 |