Trial Outcomes & Findings for Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (NCT NCT03155620)

Last Updated: 2026-05-05

Results Overview

Match rate will be calculated as the percent of eligible patients who have an actionable mutation of interest and are matched to at least one of the subprotocols, and confidence intervals will be constructed using the Wilson score interval method. Patients enrolled on or after Amendment 4 will not be included in this analysis as screening of unselected patients will no longer be conducted.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

1377 participants

Primary outcome timeframe

Up to 2 years from study entry

Results posted on

2026-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Overall Study STARTED	1377
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1377

Reasons for withdrawal

Reasons for withdrawal
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Overall Study Death	903
Overall Study Lost to Follow-up	25
Overall Study Physician Decision	27
Overall Study Withdrawal by Subject	15
Overall Study Ineligible	16
Overall Study 5th anniversary of the most recent date of patient enrollment onto a subprotocol	25
Overall Study Two years from date of patient enrollment onto APEC1621SC if not enrolled onto a subprotocol	348
Overall Study Two years from date of technical failure	6
Overall Study Still On Study/in Follow-Up on APEC621SC	12

Baseline Characteristics

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol n=1377 Participants Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Age, Categorical <=18 years	1211 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	166 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants
Age, Continuous	12.1 years STANDARD_DEVIATION 5.4 • n=54 Participants
Sex: Female, Male Female	602 Participants n=54 Participants
Sex: Female, Male Male	775 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	315 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	999 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	63 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=54 Participants
Race (NIH/OMB) Asian	54 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	11 Participants n=54 Participants
Race (NIH/OMB) Black or African American	201 Participants n=54 Participants
Race (NIH/OMB) White	928 Participants n=54 Participants
Race (NIH/OMB) More than one race	21 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	157 Participants n=54 Participants
Region of Enrollment United States	1377 participants n=54 Participants

PRIMARY outcome

Timeframe: Up to 2 years from study entry

Population: Patients enrolled after Amendment 4 are not included in this analysis

Outcome measures

Outcome measures
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol n=1158 Participants Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Proportion of Pediatric Patients Whose Advanced Tumors Have Pathway Alterations That Can be Targeted by Select Anti-cancer Drugs	28 Percentage of patients Interval 25.5 to 30.6

SECONDARY outcome

Timeframe: Up to 2 years from study entry

Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 4 years

A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

Will be evaluated through circulating tumor deoxyribonucleic acid (DNA). A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the National Clinical Trial Network (NCTN) group setting.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

Adverse Events

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Serious events: 2 serious events

Other events: 1 other events

Deaths: 906 deaths

Serious adverse events

Serious adverse events
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol n=1343 participants at risk Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Infections and infestations Infections and infestations - Other, specify	0.07% 1/1343 • The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years. Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.
Infections and infestations Meningitis	0.07% 1/1343 • The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years. Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.07% 1/1343 • The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years. Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.

Other adverse events

Other adverse events
Measure	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol n=1343 participants at risk Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
Nervous system disorders Headache	0.07% 1/1343 • The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years. Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 6262411500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60