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Protocol Summary


Protocol No.
PSCI-21-026
Prinicipal Investigator
Joshi, Monika
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
D910PC00001
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 (VOLGA)
Objective
Primary: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin.

Secondary: To evaluate the efficacy of durvalumab + tremelimumab + EV on pCR rate and EFS.
Applicable Disease Sites
Urinary Bladder
Status
Open
Participating Institutions
Hershey Medical Center