A Phase II Study of Olaparib and Durvalumab Immunotherapy in Prostate Cancer

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Full Title

A Phase II Study of Olaparib and Durvalumab in Men with Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair

Purpose

The purpose of this study is to assess the safety and effectiveness of giving durvalumab immunotherapy plus olaparib in men with prostate cancer who have had the prostate removed and show evidence that the cancer has come back (rising PSA level), but is not visible on a CT or bone scan.

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 had prostatectomy and have rising PSA levels that indicate the cancer has come back.
  • Patients cannot have evidence on a CT or bone scan that the cancer has spread.
  • Patients’ cancers must have mutations in the genes involved in DNA damage repair.
  • Patients may not be receiving androgen deprivation (hormonal) therapy.
  • Patients may not have previously received immunotherapy (drugs like durvalumab) or a PARP inhibitor (drugs like olaparib).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the study research team/Dr. Karen Autio at 646-422-4632.

Protocol

18-480

Phase

II

Investigator

Co-Investigators