NCI-MATCH will use a single DNA sequencing test to identify gene mutations in patients' tumors. The NCI Molecular Characterization Laboratory at the NCI Frederick National Laboratory for Cancer Research in Frederick, Maryland, has developed the test which looks for 143 genes associated with cancer that can be targeted by drugs in the trial. To ensure quality control, biopsy specimens from all 3,000 screened patients will be sent to a single location for processing: the ECOG-ACRIN Central Biorepository and Pathology Facility at the University of Texas MD Anderson Cancer Center in Houston. The DNA sequencing analysis will be done at one of four facilities using a standardized process.
"The use of a unique kit for specimen collection, shipment, and centralized tissue processing, assures high-quality analysis," said ECOG-ACRIN laboratory lead, Stanley R. Hamilton, M.D., head of pathology and laboratory medicine at the MD Anderson Cancer Center. "The network of four molecular diagnostics labs provides capacity for large numbers of patients to be screened in the trial. Pilot testing of specimens across the four locations showed remarkable reproducibility of the molecular results — another important aspect of quality assurance in trials of this scope and scale."
The cancer treatment drugs being used in NCI-MATCH include both US Food and Drug Administration approved drugs as well as investigational agents that are being contributed by a number of pharmaceutical companies. Most of the arms in the trial will incorporate single-agent drugs that are either commercially available or are still being tested in clinical trials. However, a few arms will contain combinations of drugs for which there are enough safety data and evidence that they might be active against a particular genetic abnormality.
Since NCI-MATCH is designed to explore whether drugs are effective against specific molecular abnormalities, patients who have tumors that can be treated with a drug already approved by the FDA for their molecular abnormality will not be eligible to use the same drug in NCI-MATCH. They could be considered for other drugs within NCI-MATCH if they have already received an approved therapy and have a different genetic abnormality that could be targeted with a new drug.
There are two main clinical endpoints in the NCI-MATCH trial. The primary endpoint is the overall response rate, which is the proportion of patients in the trial whose tumors shrink by a predefined amount over a specific time period. The secondary endpoint is 6-month progression-free survival, which is a measure of whether a patient's disease remains stable.
"For our purposes, a response rate of 5 percent or less in a molecularly-defined population will not be considered promising, whereas a response rate of 16 percent to 25 percent will be encouraging," said NCI study co-chair Barbara A. Conley, M.D., associate director of the NCI’s Cancer Diagnosis Program. "After starting treatment in NCI-MATCH, a 6-month progression-free survival of 15 percent will not be considered promising, whereas a progression-free survival at six months of 35 percent will indicate that we would want to develop that treatment further."
Enrollment in NCI-MATCH will be available across the country through NCTN sites. In addition, the trial will be available through sites nationwide that participate in the NCI Community Oncology Research Program. All of the approximately 2,400 sites that participate in the trial will use the NCI Central Institutional Review Board as the institutional review board of record. Sites will access the trial under the protocol identification EAY131 via the NCI Cancer Trials Support Unit.
The principal investigators who will lead the substudies are situated throughout the NCTN and its participating network groups: ECOG-ACRIN, the Alliance for Clinical Trials in Oncology, NRG Oncology and SWOG. All of these investigators have expertise in molecular studies, and many are junior researchers involved with, and being mentored by, experienced senior investigators. Patient advocates were engaged in the development of the trial and will help oversee the protocol and other aspects of the study.
The National Cancer Institute leads the National Cancer Program and the NIH's efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER.
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