National Cancer Institute–Children’s Oncology Group
Pediatric MATCH Trial

The Trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice), also known as Pediatric MATCH, is a pediatric precision medicine cancer treatment trial that explores whether targeted therapies can be effective for children and adolescents with solid tumors that harbor specific gene mutations. Pediatric MATCH is a phase 2 trial that will investigate more than eight different study drugs, each targeting a defined set of gene mutations, in order to match patients with therapies aimed at the molecular abnormalities in his or her tumor.

Patient Eligibility

Pediatric MATCH is a trial for children and adolescents ages 1 to 21 who have solid tumors, including non-Hodgkin lymphomas, brain tumors, and histiocytoses, that no longer respond to standard treatment or have recurred after treatment. A similar, but separate trial for adults, the NCI-MATCH study, has been enrolling adult patients since August 2015 and is also matching patients to treatments based on genetic mutations in tumors.

Patients must have a tumor sample (formalin fixed paraffin embedded tissue) available for molecular characterization from the time the tumor recurred or progressed after treatment, except for diffuse intrinsic pontine glioma in which case the diagnostic biopsy will be accepted.

Trial Availability and Patient Identification

Enrollment in Pediatric MATCH will be available through about 200 COG sites in the United States. To find the COG member institutions in the United States, visit the “Finding a COG Location” page at: https://www.childrensoncologygroup.org/index.php/locations/. Sites will access the trial under the protocol identification APEC1621 via the NCI Cancer Trials Support Unit (CTSU).  

The trial has two enrollment steps. Each patient will initially enroll for a screening study, in which a sample of his or her relapsed tumor will undergo DNA and RNA sequencing to detect genetic abnormalities that could be targeted by one or more of the drugs being studied. Archived tumor samples can be used as long as they were obtained after the tumor progressed following initial treatment. If there is a genetic abnormality identified in the tumor and a drug in Pediatric MATCH that targets that abnormality, the patient can then enroll in the corresponding treatment arm if he or she meets the eligibility criteria.

 



 

Pediatric MATCH will use a single sequencing test to screen for many molecular abnormalities at once. The test, which is also being used for the adult NCI-MATCH trial, was developed by the NCI Molecular Characterization Laboratory at the NCI Frederick National Laboratory for Cancer Research in Frederick, Maryland. The latest version of this test looks for alterations in more than 160 genes associated with cancer.

To ensure quality control, biopsy specimens from all patients will be sent to a single location, the COG Biopathology Center in Columbus, Ohio, for processing of DNA and RNA. The sequencing analysis will be done at one of several laboratories that are also being used for the adult NCI-MATCH trial.  

It is important to note that, in contrast to cancers that occur in adult patients, key cancer mutations for which experimental drugs are currently available are expected to be found in only 5 to 10 percent of tumors from children and adolescents with cancer. The trial investigators therefore plan to screen 200 to 300 patients a year, for a total of 1,000 patients screened, to identify patients potentially eligible for each of the sub-studies.

Treatment Overview

Patients with a matched drug will be able to receive experimental treatment for as long as their tumors are stable in size or getting smaller.

Treatment Arms

The trial currently has 7 treatment arms open (see list below). It is anticipated that another two arms will be added as the trial progresses. At least 20 patients will be enrolled in each arm.

The current treatment arms are:

  • APEC1621A: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LOXO-101 in patients with tumors harboring actionable NTRK fusions.
  • APEC1621C: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of tazemetostat for patients with tumors harboring alterations in EZH2 or members of the SWI/SNF complex
  • APEC1621D: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LY3023414 in solid tumors
  • APEC1621E: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)–  Phase 2 subprotocol of selumetinib in patients with tumors harboring activating MAPK pathway mutations
  • APEC1621F: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations
  • APEC1621G: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of vemurafenib in patients with tumors harboring actionable BRAF V600 mutations
  • APEC1621H: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of olaparib in patients with tumors harboring defects in DNA damage repair genes

Goals of Pediatric MATCH

In addition to getting further information about the proportion of pediatric patients whose tumors have genetic alterations that can be targeted by select drugs, the primary endpoint for each matched drug is the overall response rate, or the proportion of patients whose tumors shrink by a predefined amount over a specific time period. A number of other laboratory studies are planned that will help increase the scientific understanding of a range of relapsed cancers that occur in children and adolescents.

Although most of the DNA mutations identified in study patients will have occurred only in the cancers themselves (and not elsewhere in the body), some may have been inherited, which could have clinical implications for testing and cancer prevention strategies in family members. Accordingly, study investigators plan to sequence the blood of each patient in addition to their tumor sample.

As it is anticipated that only a small number of patients will have a tumor with an identified genetic abnormality that can be targeted, for those patients found not to have a matched drug, results from the screening test will be shared with their oncologists. These patients may be able to enroll in other studies found through the COG Developmental Therapeutics Program, Pediatric Brain Tumor Consortium, New Approaches to Neuroblastoma Therapy, and pharmaceutical trials located through clinicaltrials.gov.

Trial Collaborators

The study was developed and will be led jointly by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the Children’s Oncology Group (COG), one of the five NCI National Clinical Trials Network (NCTN) groups.

COG 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.

Learn More

To learn more about Pediatric MATCH, patients and their families should start by speaking with their doctors or healthcare team. 

Trained information specialists at the NCI’s Contact Center (formerly known as the Cancer Information Service) are available at 1-800-4-CANCER (1-800-422-6237) to answer questions about Pediatric MATCH in English and Spanish or visit cancer.gov and contact NCI's LiveHelp online service.  

Additional Resources

For more information on NCI-COG Pediatric MATCH, go to www.cancer.gov/pediatricmatch.