NCI-MATCH, also known as National Cancer Institute-Molecular Analysis for Therapy Choice, or study 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 their cancer type. Such discoveries could be eligible to move on to larger, more definitive trials.
To find patients who may be eligible for this trial, study leaders are collaborating with designated commercial and academic laboratories that test patients through standard tumor testing procedures. Tumor gene testing by a designated lab is the only pathway for new patients to enroll into the trial.
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:
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.
The following commercial laboratories are designated to identify patients at participating clinical sites for the NCI-MATCH trial:
|Name||Date of Inclusion|
|Caris Life Sciences®||06/23/2017|
|Foundation Medicine, Inc.||05/11/2017|
The following academic laboratories are designated to identify their own patients for the NCI-MATCH trial using their institutional assay:
|Name||Date of Inclusion|
|Memorial Sloan Kettering Cancer Center||08/03/2017|
|The University of Texas MD Anderson Cancer Center||05/11/2017|
Collectively, the designated labs conduct genomic sequencing for tens of thousands of people with cancer, which is necessary to identify patients whose tumor gene abnormalities match those being studied in the trial. This is the first NCI-sponsored trial to use this new approach. Trial leaders are currently working together with the labs listed above in a demonstration project to develop a standard model for others to use.
The demonstration project took effect on May 11, 2017. Initially, the labs are reporting on 19 of NCI-MATCH’s treatment arms–those that address the rarest gene abnormalities being studied in the trial. This trial defines a gene abnormality as ‘rare’ if it was found in 1.5 percent or fewer of the 6000 patients tested centrally in the trial. The number of treatments arms will change as reach their enrollment goals. There is potential to include other treatment arms in the trial once the demonstration project is complete and a standard model is in place.
The demonstration project also stages laboratory involvement. Foundation Medicine, Inc. and The University of Texas MD Anderson Cancer Center began reporting to physicians on May 11, 2017. Caris Life Sciences® began reporting to physicians on June 23, 2017. Memorial Sloan Kettering Cancer Center began reporting to physicians on August 3, 2017.
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 academic laboratories.
There is also potential to include additional laboratories. To this end, the NCI, in collaboration with the NCI-MATCH trial leadership, is inviting applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing next generation sequencing assays to participate in the NCI-MATCH trial. The Federal Register Notice for letters of interest (LOIs) was issued August 2, 2017. LOIs are due January 31, 2018. Please use the following link to access the full information: Federal Register Vol. 82, No. 147. Pgs. 35976-35978.
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