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)

NCT03155620 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: NCI-2017-01251APEC1621SCU10CA180886
• Study Type: interventional
• Target: 1,377
• Locations: 4 countries
• Sites: 172

Brief Summary

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.

Conditions

Ann Arbor Stage III Non-Hodgkin Lymphoma; Recurrent Malignant Germ Cell Tumor; Wilms Tumor; Histiocytic Sarcoma; Advanced Malignant Solid Neoplasm; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Refractory Rhabdoid Tumor; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years from study entry

Secondary Outcomes (1)

• Objective Response Rate (ORR) to Targeted Therapy in Tumors Lacking Actionable Alterations

  Up to 2 years from study entry

Other Outcomes (5)

• Genomic Landscape of Advanced Pediatric Solid Tumors, Non-Hodgkin Lymphomas, and Histiocytic Disorders

  Up to 4 years

• Change in Genomics in Advanced Pediatric Cancers

  Baseline up to 4 years

• Diagnostic and Profiling Genomics of Tumor Approach

  Up to 4 years

Study Arms (13)

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion)

EXPERIMENTAL

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

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation)

EXPERIMENTAL

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

Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation)

EXPERIMENTAL

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

Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation)

EXPERIMENTAL

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

Subprotocol E (activating MAPK pathway gene mutation)

EXPERIMENTAL

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

Subprotocol F (ALK or ROS1 gene alteration)

EXPERIMENTAL

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

Subprotocol G (BRAF V600 gene mutation)

EXPERIMENTAL

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

Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations)

EXPERIMENTAL

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

Subprotocol I (Rb positive, alterations in cell cycle genes)

EXPERIMENTAL

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

Subprotocol J (MAPK pathway mutations)

EXPERIMENTAL

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

Subprotocol K (IDH1 gene mutation)

EXPERIMENTAL

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

Subprotocol M (HRAS gene alterations)

EXPERIMENTAL

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

Subprotocol N (activating RET mutations)

EXPERIMENTAL

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

Interventions

Ensartinib DRUG

Given PO

Also known as: X 396, X-396, X396

Subprotocol F (ALK or ROS1 gene alteration)

Erdafitinib DRUG

Given PO

Also known as: Balversa, JNJ 42756493, JNJ-42756493, JNJ42756493

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation)

Ivosidenib DRUG

Given PO

Also known as: AG 120, AG-120, AG120, Tibsovo

Subprotocol K (IDH1 gene mutation)

Laboratory Biomarker Analysis OTHER

Undergo molecular analysis

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion); Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation); Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation); Subprotocol E (activating MAPK pathway gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol G (BRAF V600 gene mutation); Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations); Subprotocol I (Rb positive, alterations in cell cycle genes); Subprotocol J (MAPK pathway mutations); Subprotocol K (IDH1 gene mutation); Subprotocol M (HRAS gene alterations); Subprotocol N (activating RET mutations)

Palbociclib DRUG

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

Subprotocol I (Rb positive, alterations in cell cycle genes)

Positron Emission Tomography PROCEDURE

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

Subprotocol F (ALK or ROS1 gene alteration); Subprotocol N (activating RET mutations)

Radionuclide Imaging PROCEDURE

Undergo radionuclide imaging

Also known as: Gamma Scan, NM, Nuclear Medicine, nuclear medicine scan, radioimaging, Radionuclide Scanning, Scan, Scintigraphy

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol N (activating RET mutations)

Selumetinib Sulfate DRUG

Given PO

Also known as: AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate

Subprotocol E (activating MAPK pathway gene mutation)

Tipifarnib DRUG

Given PO or via nasogastric or gastric tube

Also known as: R115777, Zarnestra

Subprotocol M (HRAS gene alterations)

Ulixertinib DRUG

Receive PO

Also known as: BVD-523, VRT752271

Subprotocol J (MAPK pathway mutations)

Vemurafenib DRUG

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

Subprotocol G (BRAF V600 gene mutation)

Larotrectinib Sulfate DRUG

Given PO or via nasogastric- or gastric-tube

Also known as: ARRY 470 Sulfate, LOXO 101 Sulfate, LOXO-101 Sulfate, Vitrakvi

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion)

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion); Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation); Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation); Subprotocol E (activating MAPK pathway gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol G (BRAF V600 gene mutation); Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations); Subprotocol I (Rb positive, alterations in cell cycle genes); Subprotocol J (MAPK pathway mutations); Subprotocol K (IDH1 gene mutation); Subprotocol M (HRAS gene alterations); Subprotocol N (activating RET mutations)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion); Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation); Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation); Subprotocol E (activating MAPK pathway gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol G (BRAF V600 gene mutation); Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations); Subprotocol I (Rb positive, alterations in cell cycle genes); Subprotocol J (MAPK pathway mutations); Subprotocol K (IDH1 gene mutation); Subprotocol M (HRAS gene alterations); Subprotocol N (activating RET mutations)

Bone Scan PROCEDURE

Undergo a bone scan

Also known as: Bone Scintigraphy

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration)

Computed Tomography PROCEDURE

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

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol N (activating RET mutations)

Bone Marrow Aspiration and Biopsy PROCEDURE

Undergo a bone marrow and/or biopsy

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration)

Magnetic Resonance Imaging PROCEDURE

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

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol N (activating RET mutations)

Mutation Carrier Screening PROCEDURE

Undergo tumor tissue mutation screening

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion); Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation); Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation); Subprotocol E (activating MAPK pathway gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol G (BRAF V600 gene mutation); Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations); Subprotocol I (Rb positive, alterations in cell cycle genes); Subprotocol J (MAPK pathway mutations); Subprotocol K (IDH1 gene mutation); Subprotocol M (HRAS gene alterations); Subprotocol N (activating RET mutations)

Olaparib DRUG

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281

Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations)

Pharmacological Study OTHER

Correlative studies

Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion); Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation); Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation); Subprotocol E (activating MAPK pathway gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol G (BRAF V600 gene mutation); Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations); Subprotocol I (Rb positive, alterations in cell cycle genes); Subprotocol J (MAPK pathway mutations); Subprotocol K (IDH1 gene mutation); Subprotocol M (HRAS gene alterations); Subprotocol N (activating RET mutations)

Samotolisib DRUG

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

Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation)

Selpercatinib DRUG

Given PO

Also known as: LOXO 292, LOXO-292, LOXO292, RET Kinase Inhibitor LOXO-292, Retevmo, Retsevmo, WHO 10967

Subprotocol N (activating RET mutations)

Tazemetostat DRUG

Given PO

Also known as: E 7438, E-7438, E7438, EPZ 6438, EPZ-6438, EPZ6438

Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation)

X-Ray Imaging PROCEDURE

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

Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation); Subprotocol F (ALK or ROS1 gene alteration); Subprotocol N (activating RET mutations)

Eligibility Criteria

• Age: 12 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis \[LCH\], juvenile xanthogranuloma \[JXG\], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma are not eligible
• 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 biopsy 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
• Please note: Samples that have been decalcified using standardly utilized acid-based decalcification methods are not generally suitable for MATCH study testing; the nucleic acids will have been degraded in the decalcification process
• 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)
• This molecular profiling must have been performed on a tumor sample that was obtained at any point after initial tumor recurrence/progression and must be accompanied by a pathology report for the same tumor specimen; a molecular profiling report for a diagnostic (pre-treatment) tumor sample will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus. In the event that molecular profiling reports are available from multiple timepoints, the most recent report should be prioritized for study submission
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age); note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have radiographically measurable disease; 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:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or CSF
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

You may not qualify if:

• Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid
• Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (172)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner Children's at Desert

Mesa, Arizona, 85202, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

Location

Valley Children's Hospital

Madera, California, 93636, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Naval Medical Center -San Diego

San Diego, California, 92134, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

Location

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

OSF Children's Hospital of Illinois

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Michigan State University

East Lansing, Michigan, 48823, United States

Location

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Corewell Health Children's

Royal Oak, Michigan, 48073, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

El Paso Children's Hospital

El Paso, Texas, 79905, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415, United States

Location

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

Location

University Pediatric Hospital

San Juan, 00926, Puerto Rico

Location

Related Publications (3)

• Scollon S, Plon SE, Joffe S, Biegel JA, Kulkarni S, Miles G, Patton DR, Coffey B, Winter CL, Tsongalis GJ, Routbort MJ, Ramirez NC, Saguilig L, Piao J, Alonzo TA, Berg SL, Fox E, Weigel B, Hawkins DS, Abrams JS, Mooney M, Takebe N, Tricoli JV, Janeway KA, Seibel NL, Parsons DW; NCI-COG Pediatric MATCH Germline Reporting Committee. Germline Cancer Predisposition Results From the National Cancer Institute-Children's Oncology Group Pediatric MATCH Trial. JCO Precis Oncol. 2025 Oct;9:e2500742. doi: 10.1200/PO-25-00742. Epub 2025 Oct 30.

  PMID: 41166674 DERIVED

• Parsons DW, Janeway KA, Patton DR, Winter CL, Coffey B, Williams PM, Roy-Chowdhuri S, Tsongalis GJ, Routbort M, Ramirez NC, Saguilig L, Piao J, Alonzo TA, Berg SL, Fox E, Hawkins DS, Abrams JS, Mooney M, Takebe N, Tricoli JV, Seibel NL; NCI-COG Pediatric MATCH Team. Actionable Tumor Alterations and Treatment Protocol Enrollment of Pediatric and Young Adult Patients With Refractory Cancers in the National Cancer Institute-Children's Oncology Group Pediatric MATCH Trial. J Clin Oncol. 2022 Jul 10;40(20):2224-2234. doi: 10.1200/JCO.21.02838. Epub 2022 Mar 30.

  PMID: 35353553 DERIVED

• Jain J, Sutton KS, Hong AL. Progress Update in Pediatric Renal Tumors. Curr Oncol Rep. 2021 Feb 16;23(3):33. doi: 10.1007/s11912-021-01016-y.

  PMID: 33591402 DERIVED

MeSH Terms

Conditions

Histiocytic Sarcoma; Xanthogranuloma, Juvenile; Histiocytosis, Langerhans-Cell; Glioma; Ependymoma; Sarcoma, Ewing; Hepatoblastoma; Medulloblastoma; Neuroblastoma; Lymphoma, Non-Hodgkin; Osteosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Central Nervous System Neoplasms; Rhabdoid Tumor; Sarcoma; Rhabdomyosarcoma; Wilms Tumor

Interventions

Biopsy; Specimen Handling; ensartinib; erdafitinib; ivosidenib; larotrectinib; Magnetic Resonance Spectroscopy; olaparib; palbociclib; Nuclear Medicine Department, Hospital; LY3023414; selpercatinib; tazemetostat; tipifarnib; ulixertinib; Vemurafenib; X-Rays; Phantoms, Imaging

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Histiocytosis, Non-Langerhans-Cell; Skin Diseases; Skin and Connective Tissue Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Neuroectodermal Tumors, Primitive; Lymphoma; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Myosarcoma; Neoplasms, Muscle Tissue; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Equipment and Supplies

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

6262411500

Study Officials

• Donald W Parsons

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: July 31, 2017
• Primary Completion: March 31, 2025
• Study Completion (Estimated): January 6, 2027
• Last Updated: June 1, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-01

Locations

US (168); AU (1); CA (1); PR (2)