Study on Selumetinib and Olaparib Combination Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05554328

Provider View

This clinical trial is testing whether a combination of two drugs, Selumetinib and Olaparib, or Selumetinib alone, can help treat ovarian and endometrial cancers that have returned or persisted after treatment and have a specific genetic mutation.

Patient Parameters

Program Overview

This study is exploring the effectiveness of two treatments for women with ovarian or endometrial cancer that has come back or hasn't gone away after treatment and has a mutation in the RAS pathway. The trial compares the use of Selumetinib alone to a combination of Selumetinib and Olaparib. Selumetinib may help stop cancer cells from growing by blocking certain enzymes, while Olaparib may prevent cancer cells from repairing their DNA, causing them to die. The study aims to see if adding Olaparib to Selumetinib can shrink tumors more effectively and keep them stable for longer compared to using Selumetinib alone.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when treated with Selumetinib and Olaparib versus Selumetinib alone. This will be tested in two groups: one with ovarian cancer and one with endometrial cancer.

The study also aims to determine the safety of both treatments and compare how well the tumors respond to each treatment. Patients who initially receive only Selumetinib and experience cancer progression may switch to the combination treatment.

Participants will be randomly assigned to one of two groups. In the first group, patients will take both Selumetinib and Olaparib by mouth twice a day in 28-day cycles. In the second group, patients will take only Selumetinib by mouth twice a day in 28-day cycles. Patients will undergo various tests, including tumor biopsies, blood tests, heart scans, and CT scans throughout the study.

After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the ComboMATCH study and have a specific genetic mutation.
  • Must have ovarian or endometrial cancer with a RAS pathway mutation.
  • Cancer must be able to be biopsied, or have a recent tissue sample available.
  • Cancer must have worsened after first-line treatment.
  • Must not be eligible for further platinum-based therapy for ovarian cancer.
  • Must have received or been offered certain treatments for endometrial cancer.
  • Can have had any number of previous treatments.
  • Must have measurable cancer that can be tracked.
  • Must be 18 years or older.
  • Must have a good performance status.
  • Must have adequate blood counts and organ function.
  • Must be able to swallow pills.
  • Women of childbearing potential must use two forms of birth control during the study and for 12 weeks after.
  • Men must use a condom and spermicide during the study and for 16 weeks after.
  • Must not have other health conditions that interfere with the study.
  • HIV-positive patients must have an undetectable viral load.
  • Patients with hepatitis B or C must have controlled or cured infections.
  • Patients with brain metastases must not need immediate treatment.
  • Must provide informed consent.

Exclusion Criteria

  • Cannot have received MEK inhibitors or progressed on a PARP inhibitor.
  • Cannot have had recent chemotherapy or radiotherapy.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have uncontrolled illnesses.
  • Cannot have severe liver dysfunction.
  • Cannot have allergies to study drugs.
  • Cannot use certain medications that interact with study drugs.
  • Cannot have certain eye conditions.
  • Cannot have severe heart or lung conditions.
  • Cannot be pregnant or breastfeeding.

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