RecruitingPhase 2

Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial

United States, Puerto Rico165 participantsStarted 2023-04-25

Plain-language summary

This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191 * Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191 * Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment * Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1) * Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1) * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191) * Patients must have progressed after first-line treatment for recurrent or persistent disease * Patients with ovarian cancer should not be eligible for further platinum-based therapy * Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib * Patients may have recei…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial testing selumetinib with or without olaparib — since it's still in Phase 2, what do we know so far about how safe and effective this combination tends to be for ovarian or endometrial cancers with a RAS pathway mutation?
2The trial is specifically for people with a RAS pathway mutation — has my tumor already been tested for that, and if not, how would we find out whether I'd even be eligible to be considered for this study?
3The trial is measuring progression-free survival as the main outcome — what does that mean in practical terms for me, and how does that compare to what I might expect from standard treatment options for recurrent or persistent disease?
4Since one group in this trial receives selumetinib plus olaparib and another receives selumetinib alone, would I have any say in which group I'm assigned to, and do you have any sense of which approach might be a better fit given my specific situation?
5Given that my cancer has already come back or hasn't fully responded to prior treatment, would you recommend considering this trial before, after, or instead of other available options — and are there standard treatments I should try first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival

Timeframe: The duration of time from enrollment to the date of progression or death, whichever occurs first, assessed up to 5 years

Trial details

NCT IDNCT05554328

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-10-01

View on ClinicalTrials.gov More Recurrent Endometrial Carcinoma trials