National Cancer Institute NCI-Match Clinical Trials Are Now Open

8/13/2015, National Clinical Trials Network

National Cancer Institute-Molecular Analysis for Therapy Choice, known as NCI-MATCH 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.

Precision medicine refers to the tailoring of treatment based on the characteristics of each individual. Treatment focuses on molecular abnormalities instead of the organ site of the cancer.

There are several broad categories of resources for this trial to help website visitors locate the most relevant information. Please see the buttons to the right to access additional information for the trial.

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

A Unique Trial

• NCI-MATCH is a unique cancer treatment trial because it is the largest, most scientifically rigorous precision medicine cancer trial to date 
   
• NCI-MATCH is considered the largest precision medicine cancer trial to date based on the number of patients, treatment options, and types of cancer being studied in a single clinical trial
  • About 3000 patients will receive genetic testing to identify about 1000 eligible for one of 22 treatment options
  • The 22 treatment options explore a large number of genetic abnormalities and drugs—far more than any other cancer trial
  • It includes a large number of cancer types (most other trials address a single cancer) and has many more drugs available than most other cancer trials
  • A network of four molecular diagnostics laboratories provides capacity for the large number of patients
     
• NCI-MATCH is considered the most scientifically rigorous precision medicine cancer trial to date
  • A single DNA sequencing test was especially developed for this trial to look for 143 genes associated with cancer
  • The use of a unique kit for biospecimen collection, shipment, and centralized processing assures high-quality analysis
  • Cutting edge molecular analysis will be performed by four laboratories. All four labs demonstrated consistent results in pilot testing—an important aspect of quality assurance in a trial of this scope and scale.

Other Ways that NCI-MATCH is Unique

• Unlike many clinical trials, this trial is not comparing the drugs or drug combinations with each other, but is studying each treatment’s effectiveness on its own
   
• The depth and breadth of expertise among the investigators and staff involved in the trial is unprecedented, and includes hundreds of translational scientists, clinical oncologists, community practitioners, and research personnel all with deep experience in clinical trials
   
• The inclusion of uncommon types of cancer in NCI-MATCH offers patients an unusual opportunity to have their disease assessed to see if it has the same genetic abnormalities found in more common cancer types
   
• It also offers researchers a unique opportunity to study the effectiveness of new treatments on rare diseases
   
• Use of the NCI Central Institutional Review Board is mandatory

Patient Eligibility

• The trial is for adults 18 years of age and older with any type of solid tumor or lymphoma (cancer in the cells of the immune system) that has returned or gotten worse after standard systemic therapy (oral or intravenous)
   
• Patients may also be eligible if they have a rare type of cancer for which there is no standard treatment
   
• The trial’s design calls for at least 25 percent of the 1000-patient enrollment to be people with rare types of cancer

Patient Selection (Enrollment)

• About 3000 patients who meet these eligibility requirements will enroll in the initial screening step of the trial and have a new biopsy
   
• The biopsy samples will undergo genetic testing to identify molecular abnormalities
   
• If a molecular abnormality is detected that is targeted by one of the drugs being studied in the trial, patients will undergo further evaluation to determine if they meet the specific eligibility requirements of that treatment arm and can be accepted in the trial

Treatment Overview

• Trial researchers expect that about 1000 patients—one third of those screened—will have one or more molecular abnormalities that match one of the 22 treatment options being studied
   
• Once enrolled, patients will be treated with a drug or drug combination that targets the molecular changes in their tumor for as long as their tumor shrinks or remains stable
   
• The drugs included in the trial have all either been approved by the U.S. Food and Drug Administration (FDA) for specific cancer types or are still being tested in other clinical trials but have shown some effectiveness against tumors with a particular genetic alteration(s)

Trial Leadership

• 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
   
• 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 will help oversee the protocol and other aspects of the study

Trial Availability

• NCI-MATCH is a nationwide trial that is locally available at community hospitals as well as at large cancer centers. Availability will grow as sites join.
   
• The trial is open with ten treatment options and will expand to 22 as treatments are added on a rolling basis
   
• Patients can enroll in the trial on a rolling basis as hospitals and cancer centers join and as the additional treatments become available
   
• To learn more about this trial, patients should start by speaking with their doctor or healthcare team
   
• Trained information specialists at the NCI Cancer Information Service are available to answer cancer-related questions in English and Spanish

Click here for more information or see the attached infographic.

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