Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 29, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ComboMATCH Screening Trial is a study that aims to find effective treatments for patients with advanced solid tumors, such as certain types of breast cancer and other cancers that have spread either locally or throughout the body. This trial focuses on using genetic testing to identify specific changes in the tumor’s genes, which can help doctors determine the best targeted therapy for each patient. To participate, patients should have measurable cancer that has either worsened after at least one standard treatment or for which there are no proven treatments available.
Eligible participants must be 18 years or older and able to undergo a biopsy to provide tumor samples for testing. They should have a performance status that indicates they can tolerate treatment and must have a documented diagnosis of a locally advanced or advanced solid tumor. Throughout the trial, participants will have access to personalized treatment plans based on their tumor’s genetic profile, and they will be closely monitored by healthcare professionals. If a patient is not eligible for the initial treatment trial, there may be opportunities to join another trial within the ComboMATCH program.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Grand Rapids, Michigan, United States
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Saint Joseph, Michigan, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Sandpoint, Idaho, United States
Ontario, Oregon, United States
Dearborn, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
Royal Oak, Michigan, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Paducah, Kentucky, United States
Madison, Wisconsin, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Macomb, Michigan, United States
Ankeny, Iowa, United States
Des Moines, Iowa, United States
Sheboygan, Wisconsin, United States
Waukee, Iowa, United States
South Portland, Maine, United States
Scarborough, Maine, United States
Rockford, Illinois, United States
Patients applied
Trial Officials
James M Ford
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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