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PSCI 21-026 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)

A clinical trial for adults with Muscle Invasive Bladder Cancer. The study is looking at alternative treatments for those persons who cannot tolerate certain forms of chemotherapy.

This protocol contains two portions. The safety run in (SRI) and the main portion of the trial. The SRI will take place over three cycles of treatment prior to having cystectomy or 9 cycles if you have had a previous cystectomy. The main study will have the same schedule of activities. The only difference between the two is the SRI will look at how safe the drug combinations are and the main trial will look at how effective they are on treating muscle invasive bladder cancer.,

Monika Joshi
CI-CTO at or 717-531-5471

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Bladder Cancer
body weight above 30kg/66 pounds

Exclusion Criteria:
Metastatic disease
history or an organ transplant
inflammatory bowel disease
Approved drug(s)
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Location Contacts
Hershey, PA ,