ComboMATCH Screening Trial for Advanced Solid Tumors

This study, called ComboMATCH, is a screening trial to help find the right treatment for people with locally advanced (spread to nearby tissue or lymph nodes) or advanced (spread to other parts of the body) solid tumors. You might be eligible if your cancer has progressed after standard treatments or if there are no standard treatments known to prolong survival. The trial uses genetic testing of your tumor cells to find specific changes or abnormalities (mutations). If mutations are found, you could be matched to a ComboMATCH treatment trial that uses drugs like alpelisib or binimetinib, which are designed to target those specific genetic changes. The goal is to see how many people can be matched and enrolled in these targeted treatment trials.

Study design
This is an interventional study with a planned enrollment of 2900 participants. It is designed to register, allocate, and assign patients to ComboMATCH treatment trials.
What's involved
You would undergo a biopsy procedure and blood collection. Bone marrow aspiration may also be performed. The duration of participation is not specified in this record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as patient accrual and assignment to treatment trials, are measured for up to 8 years.

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NCT05564377

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Recruiting
PHASE2All AgesInterventionalScreening
National Cancer Institute (NCI)
~2,900 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:AlpelisibBinimetinibBiopsy ProcedureBiospecimen CollectionBone Marrow AspirationBone Marrow Biopsy

At a glance

Recruiting sites
435 of 482 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accrual of patients to ComboMATCH treatment trials
Measured over Up to 8 years
+2 more outcomes measured
Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Unresectable HER2-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
482 sites across 45 states
Illinois62
Ohio55
Michigan45
Wisconsin45
California23
Pennsylvania21
Missouri17
Minnesota15
  • James M Ford · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

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Eligibility criteria

Inclusion

Patient must have measurable disease
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50%
Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
Patients must have progressed on at least one line of standard systemic therapy OR
Patients whose disease has no standard treatment that has been shown to prolong overall survival
Patient must meet one of the following requirements:
Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue
Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
  • Accrual of patients to ComboMATCH treatment trialsUp to 8 years

    Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).

  • Assignment of patients to ComboMATCH treatment trialsUp to 8 years

    Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).

  • Enrollment rates to ComboMATCH treatment trialsUp to 8 years

    Will be estimated over time and considered in relationship to changes in treatment trial cohort status (activations, suspensions, terminations).