NCT05554328 · National Cancer Institute (NCI)
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
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tumor biopsy
PROCEDURE
Biospecimen Collection
Undergo blood collection
PROCEDURE
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration or biopsy
PROCEDURE
Computed Tomography
Undergo CT scan
PROCEDURE
Echocardiography Test
Undergo ECHO
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
DRUG
Olaparib
Given PO
DRUG
Selumetinib Sulfate
Given PO
Primary outcome measures
Progression-free survival
Time frame: The duration of time from enrollment to the date of progression or death, whichever occurs first, assessed up to 5 years
Disease progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria, as determined by the treating physician. The primary analyses will be based on logrank tests stratified by the stratification factors as recorded at randomization. All enrolled patients will be included, regardless of compliance with their assigned study regimen. Patients will be grouped by their randomized treatment for intention-to-treat analyses. Treatment hazard ratios and 90% confidence intervals will be estimated using proportional hazards models specified with a main-effect for the randomized treatment assignment (experimental versus \[vs\] reference), and stratified using the stratification factors recorded at randomization. Treatment group differences will be graphed using Kaplan-Meier methods.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, if disease cannot be safely biopsied, or have archival tissue available from within 12 months prior to r
Where
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Goodyear, Arizona
- Kingman, Arizona
- Arroyo Grande, California
- Los Angeles, California
- Orange, California
- Palo Alto, California
- Whittier, California
- Aventura, Florida
- Coral Gables, Florida
And 221 more locations — see the full list below.
Collaborators
NRG Oncology
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations