Treatment combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or who refuse cisplatin - VOLGA
Study identifier:D910PC00001
ClinicalTrials.gov identifier:NCT04960709
EudraCT identifier:2020-005452-38
CTIS identifier:N/A
Recruiting
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 or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Medical condition
Muscle invasive bladder cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, Tremelimumab, Enfortumab Vedotin
Sex
All
Estimated Enrollment
677
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 05 Aug 2021
Estimated Primary Completion Date: 18 Jul 2025
Estimated Study Completion Date: 08 Sept 2028
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Durvalumab + Tremelimumab + Enfortumab vedotin Participants will receive 3 preoperative 21-day cycles of Durvalumab + Tremelimumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days. | Drug: Durvalumab Anti- PD-L1 Antibody Other Name: IMFINZI Other Name: MEDI4736 Drug: Tremelimumab Human IgG2 mAb Drug: Enfortumab Vedotin Nectin-4-directed antibody and microtubule inhibitor conjugate Other Name: PADCEV Procedure/Surgery: Radical Cystectomy For cisplatin-ineligible or cisplatin-refusal patients |
| Experimental: Durvalumab + Enfortumab vedotin Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days. | Drug: Durvalumab Anti- PD-L1 Antibody Other Name: IMFINZI Other Name: MEDI4736 Drug: Enfortumab Vedotin Nectin-4-directed antibody and microtubule inhibitor conjugate Other Name: PADCEV Procedure/Surgery: Radical Cystectomy For cisplatin-ineligible or cisplatin-refusal patients |
| Active Comparator: Cystectomy with or without approved Adjuvant Therapy. Participants may receive SoC (nivolumab approved as adjuvant treatment for MIBC based on high risk criteria) per approved label in the country OR Participants receive standard of care surgery (radical cystectomy) alone. | Procedure/Surgery: Radical Cystectomy For cisplatin-ineligible or cisplatin-refusal patients |
