Frequently Asked Questions About NCI-MATCH

Listed below are common questions about NCI-MATCH, 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:

• Age: adults 18 years of age and older
• Cancer Types: any solid tumor, lymphoma (cancer in the cells of the immune system), or myeloma (cancer in the bone or soft tissue) that has returned or gotten worse after standard systemic therapy (oral or intravenous) OR a type of cancer for which no standard treatment exists that has been shown to prolong overall survival
• Geography: patients receiving care at a participating clinical site in the United States
• Tumor Gene Testing: patients with a referral from a designated commercial or cancer center laboratory that shows they have gene abnormality and disease characteristics that match one of the treatment arms in the trial.

Where (at what clinical sites) is the trial available?

NCI-MATCH is a 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.

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 tumor 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:

1. The process begins when a physician at a participating trial site orders routine genomic sequencing from a designated lab to guide clinical care for his or her patient
2. The designated lab looks for tumor gene abnormalities being studied in NCI-MATCH as part of its standard testing procedure
3. If the patient matches to the trial, the lab contacts the patient’s physician and provides a written referral letter or email
4. If the patient and the physician decide to pursue NCI-MATCH as a treatment option, the physician uses the laboratory referral letter or email to register the patient into the trial for a screening assessment (Step 0). Cancer patients who enroll in the NCI-MATCH trial for a screening assessment will do so knowing in advance that they have a tumor gene abnormality matching one of the treatment arms in the trial, and that they have a type of cancer that is allowed in that arm.
5. Centrally, trial leaders review the referral. If they verify the referral, they formally assign the patient to the treatment arm and notify their physician.
6. During the screening assessment (Step 0), the physician will evaluate the patient further for the specific eligibility requirements for the treatment arm to which they match
7. Once enrolled into the treatment arm, the patient 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

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 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.

Are patients with lab referrals guaranteed to get treated in the trial?

No. The lab referral provides patients the opportunity to enter the trial for an assessment of their eligibility for treatment on the trial. It is important for patients to know that the assessment may find that they do not meet all of the eligibility requirements for treatment on NCI-MATCH.

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:

1. A mechanism that can review large numbers of patient cases is necessary to identify small subsets with tumor gene abnormalities being studied in the NCI-MATCH trial, and these labs are already testing a high volume of patients
2. The comprehensive and highly-validated genomic profiles are particularly sensitive to the tumor gene abnormalities being studied in the trial
3. Collaboration requires that the labs provide assay results in a format that can be uploaded into MATCHbox, the trial’s informatics system that generates treatment assignment information for the trial’s panel of experts to review

For a current listing of designated labs, visit the Genomic Testing section.

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. Generally, 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 35 patients although some of the arms were expanded to accommodate more patients, especially arms addressing more common tumor genes. To learn the status of each treatment arm, visit Treatment Arms section.