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Protocol No. UW17154

Principal Investigator Emamekhoo, Hamid

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title Phase Ib/II Study of Concurrent Durvalumab And Radiation Therapy (DUART) Followed by Adjuvant Durvalumab in Patients with Urothelial Cancer (T2-4 N0-2 M0) of the Bladder

Objective The main purpose of this study is to find the safe dose of study drug durvalumab in combination with radiation therapy, and to find out the length of time the study combination controls cancer. Durvalumab has been approved by the U.S. Food and Drug Administration (FDA) to treat advanced bladder cancer. The use of durvalumab with radiation therapy is investigational. “Investigational” means this combination has not been approved by the FDA.

Treatment Everyone on this study will receive durvalumab with radiation therapy. Participants whose disease stays stable or improves will continue on durvalumab alone for up to one year

Description Phase 1b/II Durvalumab and Radiation Therapy in Urothelial cancer of the bladder

Key Eligibility Phase Ib subjects
Locally advanced urothelial cancer of bladder who have any of the following:
  • T3-4, N0-2 M0, OR Tx N1-2 M0 OR T2 N1-2 M0 treatment naïve who are either unresectable, OR medically unfit for surgery OR cisplatin ineligible. Please note that T3 N0 M0 patients can be included if they are cisplatin ineligible
  • Patients who have T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 post-neoadjuvant chemotherapy who become unresectable OR are medically unfit for surgery
    Phase II subjects: Locally advanced urothelial cancer of bladder with any of the following:
  • T3-4, N0-2 M0 OR Tx N1-2 M0 OR T2 N1-2 M0: Treatment naïve, unresectable, OR medically unfit for surgery OR cisplatin ineligible Please note that T3 N0 M0 patients can be included if they are cisplatin ineligible
  • T3-4, N0-1 M0 OR Tx N1-2 M0 OR T2 N1-2 M0 patients postneoadjuvant chemotherapy who become unresectable OR unfit for surgery
  • T2, N0, M0 patients, treatment naïve, who are cisplatin ineligible can be included in the study
    All subjects:
  • Age > 18 years at time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy of >6 months
  • Histologically proven urothelial carcinoma of bladder with predominant transitional cell component. Adenocarcinoma, squamous cell differentiation, or other atypical histology (such as plasmacytoid or sarcomotoid) of the bladder will be allowed on the study, provided they form <50% of the histology
  • Subjects must have archival tissue available from previous TURBT (preferred) or lymph node core biopsy
  • Adequate normal organ and marrow function
  • No previous systemic immunotherapy. Previous use of intravesical BCG is acceptable
  • No previous radiation therapy to the pelvic area

  • Applicable Disease Sites Bladder

    Status Open

    Participating Institutions UW Hospital and Clinics