Spots Global Cancer Trial Database for Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer

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Trial Identification

Brief Title: Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer

Official Title: Multi-Institutional Phase II Study of Radiation Therapy and Anti-PD-L1 Checkpoint Inhibition (Durvalumab) With or Without Anti-CTLA-4 Inhibition (Tremelimumab) in Patients With Unresectable, Muscle-Invasive or Metastatic Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy

Study ID: NCT03150836

Conditions

Bladder Cancer

Interventions

Durvalumab

Tremelimumab

Radiation Therapy

Study Description

Brief Summary: This is a multi-site, randomized, prospective, open-label phase II study. Patients in this study will have localized (cT3-cT4), or metastatic bladder cancer with a symptomatic, intact primary bladder tumor. In this study, patients will undergo stereotactic body radiation therapy (SBRT) to the bladder tumor and will receive durvalumab with or without tremelimumab.

Detailed Description: The study will commence with a safety lead-in phase at UCSF in which 6 patients are accrued to Regimen A1 (RT + durvalumab). If this is not tolerated then an alternative Regimen A2, containing a lower total radiation dose will accrue 6 patients. If either A1 or A2 is tolerated then patients will be accrued to Regimen B1 (durvalumab, tremelimumab x 2 doses, and RT dose determined from Regimen A) following a 3+3 design for safety. If Regimen B1 is not tolerated an alternative Regimen B2 (durvalumab, tremelimumab x 1 dose, and RT dose determined from regimen A) will accrue following a 3+3 design for safety. After the safety lead-in for each group is completed, an expansion cohort will accrue patients. In this expansion cohort, patients will be randomized 1:1 to be treated with either regimen A or regimen B dose selected from the safety lead-in stratified by patient population (localized patients and metastatic patients).