NCI-MATCH Precision MedicineTrial: Determining whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type

Cancer institutes

Investigators for the nationwide trial, NCI-MATCH: Molecular Analysis for Therapy Choice, announced at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago that the precision medicine trial will open to patient enrollment in July. The trial seeks to determine whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type. NCI-MATCH will incorporate more than 20 different study drugs or drug combinations, each targeting a specific gene mutation, in order to match each patient in the trial with a therapy that targets a molecular abnormality in their tumor. The study was co-developed by the National Cancer Institute (NCI), part of the National Institutes of Health, and the ECOG-ACRIN Cancer Research Group, part of the NCI-sponsored National Clinical Trials Network (NCTN). It is being led by ECOG-ACRIN.

NCI-MATCH is a phase II trial with numerous small substudies (arms) for each treatment being investigated. It will open with approximately 10 substudies, moving to 20 or more within months. The study parameters for the first 10 arms are being sent to 2,400 participating sites in the NCTN for review in preparation for patient enrollment beginning in July. The exact date for the opening of patient enrollment will be decided shortly after the ASCO meeting. Additional substudies are in development and will be added over time as the trial progresses.

The NCI-MATCH trial has two enrollment steps. Each patient will initially enroll for screening in which samples of their tumor will be removed (biopsied). The samples will undergo DNA sequencing to detect genetic abnormalities that may be driving tumor growth and might be targeted by one of a wide range of drugs being studied. If a molecular abnormality is detected for which there is a specific substudy available, to be accepted in NCI-MATCH patients will be further evaluated to determine if they meet the specific eligibility requirements within that arm. Once enrolled, patients will be treated with the targeted drug regimen for as long as their tumor shrinks or remains stable. Overall, trial investigators plan to screen about 3,000 patients during the full course of the NCI-MATCH trial to enroll about 1,000 patients in the various treatment arms.

Adults 18 years of age and older with solid tumors or lymphomas that have advanced following at least one line of standard systemic therapy, or with tumors for which there is no standard treatment, will be eligible. Each arm of the trial will enroll up to 35 patients. The trial’s design calls for at least a quarter of the 1,000-patients enrolled to involve people with rare types of cancer.

"NCI-MATCH is a unique, ground-breaking trial, said Doug Lowy, M.D., NCI acting director. "It is the first study in oncology that incorporates all of the tenets of precision medicine. There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities. It holds the potential to transform cancer care.

Since many gene mutations in tumors are infrequent or unique, screening for individual mutations is not cost-effective or efficient in clinical trials. Instead, NCI-MATCH will use advanced gene sequencing techniques to screen for many molecular abnormalities at once. Large numbers of patient tumors will need to be screened because most gene mutations occur in 10 percent or less of cancer patients. Most patients are expected to have one, or at most two, treatable mutations in their tumors. By having multiple treatments available for these genetic abnormalities in a single clinical trial, several different study drugs or drug combinations can be evaluated simultaneously.

"In addition to exploring very fundamental aspects of cancer biology and therapy, this trial will bring cutting-edge molecular analysis and a large portfolio of targeted therapy treatment regimens to patients being treated at oncology practices large and small," said ECOG-ACRIN study chair, Keith T. Flaherty, M.D., a medical oncologist at Massachusetts General Hospital and associate professor, Harvard Medical School, both in Boston.

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NCI-MATCH Precision MedicineTrial: Determining whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type

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