NCI-MATCH, also known as National Cancer Institute-Molecular Analysis for Therapy Choice, or EAY131, is a phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of its type. Such discoveries could be eligible to move on to larger, more definitive trials.
Disclaimer: Personnel in clinical sites must review the master protocol for complete eligibility requirements and NOT rely upon this overview, which is not intended to be a comprehensive listing of inclusion and exclusion criteria.
Who is the trial for?
The trial is for cancer patients who meet all of the following pre-qualifications:
Where (at what clinical sites) is the trial available?
NCI-MATCH is nationwide trial that is open and enrolling patients at nearly 1100 cancer centers and community hospitals in every state, the District of Columbia, and Puerto Rico. For locations, visit the NCI website.
Who is leading and funding the trial?
NCI-MATCH was co-developed by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the ECOG-ACRIN Cancer Research Group, one of five NCI National Clinical Trials Network groups. The trial is publicly funded by the NCI. ECOG-ACRIN is leading the trial, a role that involves coordinating the genetic testing and supporting trial sites with training, laboratory services, trial assignments, biostatistical support, data management, auditing, quality control, and public awareness. Patient advocates were engaged in the development of the trial and are giving input on its implementation and other aspects of the study.
How are patients identified for this trial?
To find patients at participating clinical sites who may be eligible for this trial, study leaders are collaborating with designated commercial and cancer center laboratories that test patients through standard tumor testing procedures. The laboratory referral process applies to any cancer patient who gets tumor gene testing at one of the nearly 1100 clinical sites participating in the trial. Following are the basic steps:
Which laboratories are designated to identify patients for this trial?
For a current listing, visit the Genomic Testing section.
Why does this trial need designated laboratories?
The drugs or drug combinations being studied in the trial have all been selected based upon evidence that they work against a particular gene abnormality, yet several of these aberrations occur only rarely in patients. This means that tens of thousands of cancer patients must be reviewed to identify the small numbers of individuals needed to complete enrollment to several of the trial’s treatment arms. Because designated labs are able to do this, they can help cast a wider net for patients who may be candidates for the trial.
When the lab finds a tumor gene abnormality that matches one being studied in the trial, the lab will also confirm that the patient has a type of cancer that is allowed in the specific treatment arm (some arms exclude certain cancers because the treatment being studied is already available for that tumor type). If the patient meets these qualifications, the lab will notify the ordering physician directly, through phone calls and emails. The physician and patient can take the information into consideration when selecting treatment options.
No, not at all. Treating oncologists routinely order tumor gene testing to help them gather information about the molecular characteristics of their patients’ tumors, to guide them in treatment selection. The designated labs for the NCI-MATCH trial do not test patients specifically for this trial. The information that they provide in the written referral letter or email to the patient’s physician is part of their standard genomic sequencing procedures.
No, tumor gene testing by a designated lab is the only way for a physician to find out if his or her patient qualifies to enroll into NCI-MATCH for a screening assessment.
Cancer patients who register for a screening assessment in the trial will do so knowing in advance that they have a tumor gene abnormality matching one of the treatment arms in the trial. They will also know in advance that they have a type of cancer that is allowed in that arm. Each treatment arm in NCI-MATCH has specific eligibility and exclusion criteria based on molecular characteristics of patients’ tumor genes, along with disease exclusion requirements (for example, some arms exclude cancer types for which there is a standard treatment already available). Another benefit to patients is that they do not have to have a separate biopsy to determine eligibility specifically for this trial.
Right now, the commercial labs are only looking at patients they tested on or after May 11, 2017, when the demonstration project began. The purpose of this limitation is to allow the trial to adjust to the higher volume of patients during the demonstration project. Designated commercial labs may NOT reissue or amend reports to meet the effective date. The potential inclusion of patients tested before May 11 is being considered. There is no date restriction for the cancer center laboratories.
Physicians who order testing follow each designated laboratory’s standard ordering and billing procedures. Neither the NCI nor the ECOG-ACRIN Cancer Research Group provide reimbursement for testing.
Trial leaders designated these laboratories after vetting their capabilities to meet the following requirements:
Does entry into this trial require patients to have a fresh or recent biopsy?
No. The trial used to require patients to have a new or recent biopsy, but that requirement only applied to the first 6000 patients, who were biopsied and tested within the trial itself, to find those who may be eligible for the treatment arms. In July 2017, we reached our goal to sequence the tumors of 6000 patients. Now, designated laboratories identify patients at participating trial sites. Tumor testing by a designated lab is the only pathway for new patients to enroll into the trial. Please note, the designated labs do not test patients specifically for this trial. The information about a match to the trial is part of their standard genomic sequencing procedures.
A patient has a tumor gene test report done by a laboratory that is not one of the designated labs; why can’t this patient be considered for enrollment?
Each treatment arm in NCI-MATCH has specific eligibility and exclusion criteria based on molecular characteristics of patients’ tumor genes, along with disease exclusion requirements. The level of assessment required goes beyond the information provided in the standard report and underlies the necessity for a specific referral for a patient to be considered. Only the designated labs are prepared to do this at this time.
Are new clinical sites able to join the trial?
Yes. Any clinical site may join the trial with approval from the NCI Central Institutional Review Board.
Do participating clinical sites order testing from the cancer centers?
No. This study entry process intends for trial sites to order testing from the designated commercial labs. The designated cancer center labs are using their own testing platforms to identify potential trial candidates from their own patient populations.
What are the treatment arms in NCI-MATCH?
To learn more about each treatment arm and its status, visit the Treatment Arms section. The chart includes prevalence rates found thus far in the NCI-MATCH trial, to emphasize how rarely these gene abnormalities occur in patients.
How many patients are needed for the treatment arms?
Each treatment arm requires either 35 or 70 patients. To learn the status of each treatment arm, visit www.ecog-acrin.org/trials/nci-match-eay131.
Will more treatment arms be added to NCI-MATCH?
Yes. Six new treatment arms are in development for possible activation in the fall of 2017, pending approval.
For more information about genomic sequencing, send an email to the designated laboratory.
Inquiries about the NCI-MATCH (EAY131) study may be directed to:
ECOG-ACRIN Cancer Research Group
Operations Office – Boston