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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 psci-cto@pennstatehealth.psu.edu or 717-531-5471
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04960709
STUDY00018157
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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
Cancer
Approved drug(s)
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,