A Phase 2 Study of Selumetinib and Olaparib or Selumetinib Alone for Ovarian and Endometrial Cancers with Certain Genetic Changes

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Full Title

A Randomized Trial of Selumetinib and Olaparib or Selumetinib alone in Patients with recurrent or persistent RAS Pathway Mutant Ovarian and Endometrial Cancers (NCI ComboMATCH - EAY191-N4) (CIRB)

Purpose

In this study, researchers are comparing selumetinib plus olaparib to selumetinib alone to treat endometrial or ovarian cancer. People in this study have cancer that came back or keeps growing after treatment. In addition, their cancers have a change (mutation or variant) in a RAS gene.

Selumetinib may stop cancer growth by blocking some of the enzymes cancer cells need to grow. Olaparib inhibits PARP, an enzyme that helps repair damaged DNA (genetic material). Blocking PARP may keep tumor cells from repairing their damaged DNA and cause them to die. Adding olaparib to selumetinib may work better against ovarian and endometrial cancer than selumetinib alone.

If you join this study, you will be randomly assigned to get either selumetinib plus olaparib or selumetinib alone. Both medicines are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have ovarian, fallopian tube, primary peritoneal, or endometrial cancer that came back or keeps growing after treatment.
  • Have a cancer with a RAS mutation.
  • Have completed prior therapies at least 4 weeks before getting the study treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call 646-888-4226.

Protocol

23-106

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05554328