NCI-MATCH Precision Medicine Trial Will Begin Enrolling Patients in July

Doug Lowy, MD, and Keith T. Flaherty, MD, Comment

The National Cancer Institute (NCI)-supported precision medicine trial known as NCI-MATCH (Molecular Analysis for Therapy Choice) will begin enrollment in July 2015. The goal of the trial is to determine whether select cancer treatments are effective against specific molecular abnormalities, regardless of tumor type.

“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,” said Doug Lowy, MD, Acting Director, NCI.

“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, MD, Medical Oncologist at Massachusetts General Hospital and Associate Professor, Harvard Medical School, both in Boston.

Trial Design
Each arm of the trial will enroll adults 18 years of age and older with advanced solid tumors and lymphomas that have advanced following administration of at least 1 standard systemic therapy. It is expected that 20 to 25 drugs will be tested in different substudies (see Table for a preliminary list of molecular targets and matching medication).

Following enrollment, patients will undergo tumor biopsy and samples of their tumors will undergo DNA sequencing to detect genetic abnormalities that are linked to tumor growth. Advanced gene sequencing techniques will be used to screen for more than 4,000 variants across 143 genes associated with malignancies that can be targeted by drugs in the substudies. If the patient has a genetic abnormality that matches one targeted by a drug used in the trial, they will undergo further evaluation to determine if they meet the eligibility criteria for that study.

The investigators plan to screen approximately 3,000 patients and enroll about 1,000 patients into the various substudies, with up to 35 patients enrolled in each substudy. NCI-MATCH hopes that at least 25% of participants will have rare cancers. The studies will be performed at up to 2,400 clinical sites across the United States that participate in the NCI’s National Clinical Trials Network.

FDA-Approved and Investigational Agents Are Included in the Trial
The cancer treatments included in NCI-MATCH include both U.S. Food and Drug Administration approved drugs as well as investigational agents. Most of the substudies involve monotherapy, but a few substudies will assess combinations of drugs for which there are enough safety data and evidence that they might be active against a particular genetic abnormality.

The primary endpoint of the trial is the overall response rate, which is the defined as the proportion of patients in the trial whose tumors shrink by at least 30% in 1 dimension (thickness, width, or length) amount over a specific time period. The secondary endpoint is 6-month progression-free survival.

“For our purposes, a response rate of 5% or less in a molecularly-defined population will not be considered promising, whereas a response rate of 25% will be encouraging,” said NCI study co-chair Barbara A. Conley, MD, Associate Director of the NCI’s Cancer Diagnosis Program.

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 coordinated by ECOG-ACRIN and is part of NCI's precision medicine program.

Patients interested in participating in NCI-MATCH can contact the NCI Contact Center—Cancer Information Services

June 11, 2015

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