A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 172 sites in 4 countries. Open to participants aged 12 Months to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Screening
This phase II Pediatric MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
PRIMARY OBJECTIVES:
I. To utilize clinical and biological data to screen for eligibility to phase 2 pathway-targeting specific subprotocols of pathway-targeting agents in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders.
II. To determine the proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs. (Completed as of Amendment #4. Patients enrolled on or after Amendment 4 will not be included in this analysis as screening of unselected patients will no longer be conducted.)
SECONDARY OBJECTIVE:
I. To obtain preliminary information on the response rate to targeted therapy in patients whose tumors lack actionable alterations as defined for the molecular analysis for therapy choice (MATCH) study, for selected agents for which efficacy is observed in the primary matched cohort.
EXPLORATORY OBJECTIVES:
I. To increase knowledge of the genomic landscape of advanced pediatric solid tumors, non-Hodgkin lymphomas, and histiocytic disorders.
II. To describe the genomic changes that occur in advanced pediatric cancers between the time of initial diagnosis and relapse, in cases for which paired tumor specimens are available.
III. To explore approaches to diagnosing and profiling genomics of advanced pediatric cancers through evaluation of circulating tumor deoxyribonucleic acid (DNA).
IV. To determine the frequency and spectrum of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas and assess the feasibility of return of those results in the National Clinical Trial Network (NCTN) group setting.
OUTLINE:
STEP 1 (SCREENING): 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.
STEP 2 (TREATMENT): Patients with a mutation targeted by one or more of the investigational drugs used in this study or those without mutations are assigned to 1 of 13 treatment subprotocols.
APEC1621A: Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate orally (PO) or via nasogastric- or gastric-tube twice daily (BID) on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621B: Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, computed tomography (CT scan), magnetic resonance imaging (MRI), radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
APEC1621C: Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621D: Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621E: Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621F: Patients with an ALK or ROS1 gene alteration receive ensartinib (ALK Inhibitor X-396) PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
APEC1621G: Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621H: Patients with deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621I: Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621J: Patients with MAPK Pathway Mutations receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621K: Patients with IDH1 gene mutations receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
APEC1621M: Patients with HRAS gene alterations receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
APEC1621N: Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.
After completion of study treatment, patients are followed up periodically.
81 studies on the registry are indexed under Histiocytosis, Langerhans-Cell; 23 are open to participants now.
This study's enrollment of 1,377 is above the median of 24 across 64 interventional studies indexed under Histiocytosis, Langerhans-Cell.
Browse Histiocytosis, Langerhans-Cell studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor molecular profiling report availability requirement for Stage 2 of Pediatric MATCH (patients enrolled starting 2022): In stage 2 of the study, no tumor samples will be submitted for centralized clinical tumor profiling; instead, a tumor molecular profiling report from a College of American Pathologists (CAP)/ Clinical Laboratory Improvements Amendments (CLIA)-approved testing laboratory must be submitted for review by the Molecular Review Committee (MRC)
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have radiographically ; measurable disease based on imaging obtained less than or equal to 56 days prior to enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
Note: The following do not qualify as measurable disease:
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard MRI or CT
Note: The following do not qualify as measurable disease:
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Stem cell infusions (with or without total-body irradiation [TBI]):
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: or radioisotope (GFR) >= 70 ml/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
Exclusion Criteria:
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate PO or via nasogastric- or gastric-tube BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Drug: Larotrectinib Sulfate · Procedure: Mutation Carrier Screening · Other: Pharmacological Study
Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Erdafitinib · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Procedure: Radionuclide Imaging · Procedure: X-Ray Imaging
Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Tazemetostat
Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Samotolisib
Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Selumetinib Sulfate
Patients with an ALK or ROS1 gene alteration receive ensartinib PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Ensartinib · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Procedure: Positron Emission Tomography · Procedure: Radionuclide Imaging · Procedure: X-Ray Imaging
Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Vemurafenib
Patients deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Drug: Olaparib · Other: Pharmacological Study
Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Drug: Palbociclib · Other: Pharmacological Study
Patients with MAPK pathway mutations receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Ulixertinib
Patients with IDH1 gene mutations receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Drug: Ivosidenib · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study
Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Other: Laboratory Biomarker Analysis · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Drug: Tipifarnib
Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.
Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Laboratory Biomarker Analysis · Procedure: Magnetic Resonance Imaging · Procedure: Mutation Carrier Screening · Other: Pharmacological Study · Procedure: Positron Emission Tomography · Procedure: Radionuclide Imaging · Drug: Selpercatinib · Procedure: X-Ray Imaging
Undergo biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo a bone marrow and/or biopsy
Undergo a bone scan
Also known as: Bone Scintigraphy
Undergo CT, PET/Ct, and/or CT/MRI
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Given PO
Also known as: X 396, X-396, X396
Given PO
Also known as: Balversa, JNJ 42756493, JNJ-42756493, JNJ42756493
Given PO
Also known as: AG 120, AG-120, AG120, Tibsovo
Undergo molecular analysis
Given PO or via nasogastric- or gastric-tube
Also known as: ARRY 470 Sulfate, LOXO 101 Sulfate, LOXO-101 Sulfate, Vitrakvi
Undergo MRI, PET/MRI, and/or CT/MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo tumor tissue mutation screening
Given PO
Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281
Given PO
Also known as: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991
Correlative studies
Undergo PET, PET/CT, and/or PET/MRI
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Undergo radionuclide imaging
Also known as: Gamma Scan, NM, Nuclear Medicine, nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan, Scintigraphy
Given PO
Also known as: 2H-Imidazo(4,5-C)quinolin-2-one, 1,3-Dihydro-8-(5-(1-hydroxy-1-methylethyl)-3-pyridinyl)-1-((2S)-2-methoxypropyl)-3-methyl-, LY 3023414, LY-3023414, LY3023414, PI3K/mTOR Inhibitor LY3023414, WHO 10889
Given PO
Also known as: LOXO 292, LOXO-292, LOXO292, RET Kinase Inhibitor LOXO-292, Retevmo, Retsevmo, WHO 10967
Given PO
Also known as: AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate
Given PO
Also known as: E 7438, E-7438, E7438, EPZ 6438, EPZ-6438, EPZ6438
Given PO or via nasogastric or gastric tube
Also known as: R115777, Zarnestra
Receive PO
Also known as: BVD-523, VRT752271
Given PO
Also known as: BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX 4032, PLX-4032, PLX4032, RG 7204, RG-7204, RG7204, RO 5185426, RO-5185426, Zelboraf
Undergo an x-ray
Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray
Proportion of Pediatric Patients Whose Advanced Tumors Have Pathway Alterations That Can be Targeted by Select Anti-cancer Drugs
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.
Time frame: Up to 2 years from study entry
Objective Response Rate (ORR) to Targeted Therapy in Tumors Lacking Actionable Alterations
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.
Time frame: Up to 2 years from study entry
Genomic Landscape of Advanced Pediatric Solid Tumors, Non-Hodgkin Lymphomas, and Histiocytic Disorders
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Time frame: Up to 4 years
Change in Genomics in Advanced Pediatric Cancers
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Time frame: Baseline up to 4 years
Diagnostic and Profiling Genomics of Tumor Approach
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.
Time frame: Up to 4 years
Frequency of Germline Cancer Susceptibility Mutations in Children With Relapsed Solid Tumors and Non-Hodgkin Lymphomas
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.
Time frame: Up to 4 years
Spectrum of Germline Cancer Susceptibility Mutations in Children With Relapsed Solid Tumors and Non-Hodgkin Lymphomas
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 NCTN group setting.
Time frame: Up to 4 years
| Milestone | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Started | 1377 |
| Completed | 0 |
| Not completed | 1377 |
| Withdrew: Death | 903 |
| Withdrew: Lost to follow-up | 25 |
| Withdrew: Physician decision | 27 |
| Withdrew: Withdrawal by subject | 15 |
| Withdrew: Ineligible | 16 |
| Withdrew: 5th anniversary of the most recent date of patient enrollment onto a subprotocol | 25 |
| Withdrew: Two years from date of patient enrollment onto apec1621sc if not enrolled onto a subprotocol | 348 |
| Withdrew: Two years from date of technical failure | 6 |
| Withdrew: Still on study/in follow-up on apec621sc | 12 |
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.
| Percentage of patients | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Proportion of Pediatric Patients Whose Advanced Tumors Have Pathway Alterations That Can be Targeted by Select Anti-cancer Drugs | 28 (25.5 to 30.6) |
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.
Results for this outcome have not been posted.
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Results for this outcome have not been posted.
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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 NCTN group setting.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol | 906/1,377 (65.8%) | 2/1,343 (0.1%) | 1/1,343 (0.1%) |
| Event | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Infections and infestations - Other, specifyInfections and infestations | 1/1343 |
| MeningitisInfections and infestations | 1/1343 |
| Laryngeal edemaRespiratory, thoracic and mediastinal disorders | 1/1343 |
| Event | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| HeadacheNervous system disorders | 1/1343 |
| Age, Categorical(Participants) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| <=18 years | 1211 |
| Between 18 and 65 years | 166 |
| >=65 years | 0 |
| Age, Continuous(years) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Mean | 12.1 ± 5.4 |
| Sex: Female, Male(Participants) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Female | 602 |
| Male | 775 |
| Ethnicity (NIH/OMB)(Participants) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| Hispanic or Latino | 315 |
| Not Hispanic or Latino | 999 |
| Unknown or Not Reported | 63 |
| Race (NIH/OMB)(Participants) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| American Indian or Alaska Native | 5 |
| Asian | 54 |
| Native Hawaiian or Other Pacific Islander | 11 |
| Black or African American | 201 |
| White | 928 |
| More than one race | 21 |
| Unknown or Not Reported | 157 |
| Region of Enrollment(participants) | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
|---|---|
| United States | 1377 |
Showing the first 100 of 172 sites across 4 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Mar 2025, 92 months.
Results were first posted in Apr 2026, 1 year after primary completion.
Of 32 phase 2 interventional studies under Histiocytosis, Langerhans-Cell, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 55 and three quarters within 85. This study's 92 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ensartinib · Erdafitinib · Ivosidenib · Larotrectinib · Olaparib · Palbociclib · LY3023414 · Selpercatinib · Selumetinib sulfate · Tazemetostat · Tipifarnib · Ulixertinib · Vemurafenib
Histiocytosis, Langerhans-Cell →
National Cancer Institute (NCI) →