NCI-MATCH Information for Researchers

NCI-MATCH (National Cancer Institute-Molecular Analysis for Therapy Choice), or EAY131, is a phase II precision medicine trial with 39 treatment arms. The trial 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.ย Such discoveries could be eligible to move on to larger, more definitive trials.

NCI-MATCH was co-developed by the National Cancer Institute and the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN). It is being co-led by the NCI and ECOG-ACRIN through its Biomarker Sciences Program.

Listed below is general information to assist research personnel who are interested in participating in the study.

Site Qualification

To become a participating trial location in the NCI-MATCH study, medical facilities (sites) must meet ALL of the criteria listed below.

  • Located in the United States
  • Utilizing the NCI Central Institutional Review Board (CIRB) as the site IRB of record for the study
  • Participating in one or more NCI-sponsored program
    • NCI National Clinical Trials Network (NCTN)
    • NCI Community Oncology Research Program (NCORP)
    • Minority/Underserved NCORP
  • Belonging to one or more NCTN group
    • Alliance for Clinical Trials in Oncology
    • Childrenโ€™s Oncology Group
    • ECOG-ACRIN Cancer Research Group
    • NRG Oncology
    • SWOG Cancer Research Network

Protocol Identification

EAY131 is the master protocol identification (ID) for the overall trial. Each treatment/genetic abnormality being studied in this trial is a treatment arms (substudy or subprotocol) of EAY131. The treatment arms are identified with additional letters and numbers added to the end of the master protocol ID; EAY131-A, for example. All subprotocols must be used in conjunction with the master protocol, EAY131.

Access to Protocol Documents

The master protocol and all subprotocol documents, along with related material, are password protected. Research personnel may access the documents on the NCI Cancer Trial Support Unit (CTSU) website, www.ctsu.org.

Timeline

NCI-MATCH (EAY131) opened to patient enrollment on August 12, 2015, with the master protocol and ten subprotocols. Additional subprotocols were added on a rolling basis through amendments to the master protocol. View the NCI-MATCH Treatment Arms Table.

Patient Registration via OPEN

In this trial, investigators register patients via the NCI Oncology Patient Enrollment Network (OPEN) Registration System, which is accessible 24 hours a day, seven days a week at the CTSU website, www.ctsu.org.

Electronic Data Capture via Medidata Raveยฎ

NCI-MATCH (EAY131) is being conducted exclusively in Medidata Raveยฎ. There are no paper case report forms for this trial. Clinical research associates (CRAs) at the sites enter data directly into Rave at The ECOG-ACRIN Data Management Team performs central office data management in Rave.

Training Requirements

This clinical trial requires research personnel at participating institutions to complete training prior to starting data entry. Medidata Raveยฎ assigns training courses as eLearnings. Listed below are the required eLearnings that pertain to NCI-MATCH (EAY131):

Required for CRAs performing data entry in Rave:

  • Electronic Data Capture (EDC) Essentials for Clinical Research Coordinators
  • ECOG-ACRIN Supplemental Training

Required for Principal Investigators and Study Chairs performing sign off on case report forms in Rave:

  • EDC Essentials for Investigators with Data Entry
  • ECOG-ACRIN Supplemental Training

Optional eLearnings for all:

  • EDC Inspection Readiness for Clinical Sites
  • Data Privacy Considerations for Clinical Sites
 
ECOG-ACRIN Cancer Research Group