A Phase II Study of Durvalumab Immunotherapy plus Olaparib as Initial Treatment of Patients with Metastatic Urothelial Cancer

Full Title

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

Purpose

The purpose of this study is to determine whether durvalumab immunotherapy plus olaparib is more effective than durvalumab alone to treat metastatic urothelial cancer in people who cannot be treated with standard platinum-based chemotherapy drugs or surgery. Patients will be randomly assigned to receive durvalumab plus olaparib or durvalumab plus a placebo (inactive pill).

Durvalumab is given intravenously (by vein) and olaparib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable metastatic urothelial cancer (including cancer of the renal pelvis, ureters, urinary bladder, or urethra) and may not have received systemic therapy (such as chemotherapy or immunotherapy) for metastatic disease.
  • Patients may not be eligible to receive platinum-based therapy or cancer surgery.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-888-4741.

Protocol

18-330

Phase

II

Investigator

Co-Investigators