USO 20403
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 D910PC00001:(VOLGA)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
-Muscle invasive transitional cell cancer of bladder ineligible to receive neoadjuvant cisplatin and medically appropriate to have radical cystectomy
-No: evidence of more than 2 positive lymph nodes or metastatic disease; taking immunosuppressive medicine greater than the equivalent of 10 mg/day of prednisone within past 14 days; autoimmune or inflammatory disorders; allogenic organ transplant that requires use of immunosuppressive medication; history of allogenic stem cell transplant;
history of active primary immunodeficiency; TB, HIV, Hepatitis B, or Hepatitis C (past or resolved hepatitis B or C allowed); ongoing significant sensory or motor neuropathy; Class IV New York Heart Association heart failure; prior radiation for bladder cancer; active keratitis or corneal ulceration (superficial punctate keratitis allowed if treated).
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