A Phase II Study of Olaparib Alone and with Tremelimumab Immunotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer

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A Phase II Randomized Trial of Olaparib versus Olaparib plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer (CIRB)

Purpose

Olaparib is a type of anticancer medication called a PARP inhibitor, which may slow down the process cancer cells use to repair their DNA. Cancer cells need to repair their DNA to survive and grow. Olaparib is already used to treat recurrent or metastatic ovarian cancer, but the cancer often continues to grow.

In this study, researchers want to see if adding the immunotherapy drug tremelimumab to olaparib therapy is more effective than olaparib alone in women with ovarian, fallopian tube, or peritoneal cancer that has not come back within six months of receiving platinum-containing anticancer treatment for recurrent disease. The researchers want to see if the two drugs together are more effective than olaparib alone for preventing cancer growth and spread.

Tremelimumab is an investigational drug that blocks CTLA4, a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer.

Patients in this study will be randomly assigned to receive olaparib alone or olaparib plus tremelimumab. Olaparib is taken orally (by mouth) and tremelimumab is given intravenously (by vein).

Eligibility

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

  • Patients must have recurrent ovarian, fallopian tube, or peritoneal cancer that was treated with platinum-containing anticancer drugs and did not come back within six months of treatment.
  • Prior treatment with PARP inhibitors for recurrent disease is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

20-015

Phase

II

Investigator

Co-Investigators