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

830

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 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria