National Cancer Institute Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH).


Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
14 04 2023
Historique:
received: 28 10 2022
revised: 09 01 2023
accepted: 17 01 2023
medline: 17 4 2023
pubmed: 21 1 2023
entrez: 20 1 2023
Statut: ppublish

Résumé

Over the past decade, multiple trials, including the precision medicine trial National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH, EAY131, NCT02465060) have sought to determine if treating cancer based on specific genomic alterations is effective, irrespective of the cancer histology. Although many therapies are now approved for the treatment of cancers harboring specific genomic alterations, most patients do not respond to therapies targeting a single alteration. Further, when antitumor responses do occur, they are often not durable due to the development of drug resistance. Therefore, there is a great need to identify rational combination therapies that may be more effective. To address this need, the NCI and National Clinical Trials Network have developed NCI-ComboMATCH, the successor to NCI-MATCH. Like the original trial, NCI-ComboMATCH is a signal-seeking study. The goal of ComboMATCH is to overcome drug resistance to single-agent therapy and/or utilize novel synergies to increase efficacy by developing genomically-directed combination therapies, supported by strong preclinical in vivo evidence. Although NCI-MATCH was mainly comprised of multiple single-arm studies, NCI-ComboMATCH tests combination therapy, evaluating both combination of targeted agents as well as combinations of targeted therapy with chemotherapy. Although NCI-MATCH was histology agnostic with selected tumor exclusions, ComboMATCH has histology-specific and histology-agnostic arms. Although NCI-MATCH consisted of single-arm studies, ComboMATCH utilizes single-arm as well as randomized designs. NCI-MATCH had a separate, parallel Pediatric MATCH trial, whereas ComboMATCH will include children within the same trial. We present rationale, scientific principles, study design, and logistics supporting the ComboMATCH study.

Identifiants

pubmed: 36662819
pii: 716092
doi: 10.1158/1078-0432.CCR-22-3334
pmc: PMC10102840
mid: NIHMS1868727
doi:

Substances chimiques

Antineoplastic Agents 0

Types de publication

Clinical Trial Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

1412-1422

Subventions

Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA016672
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180886
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233329
Pays : United States

Informations de copyright

©2023 The Authors; Published by the American Association for Cancer Research.

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Auteurs

Funda Meric-Bernstam (F)

Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.

James M Ford (JM)

Department of Medicine - Oncology, Stanford University, Stanford, California.

Peter J O'Dwyer (PJ)

Division of Hematology-Oncology, Department of Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Geoffrey I Shapiro (GI)

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Lisa M McShane (LM)

Biometric Research Program, DCTD, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

Boris Freidlin (B)

Biometric Research Program, DCTD, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

Roisin E O'Cearbhaill (RE)

Department of Medicine, Memorial Sloan Kettering Cancer Center; Weill Cornell Medical College, New York, New York.

Suzanne George (S)

Sarcoma and Bone Oncology Division, Medical Oncology Department, Dana-Farber Cancer Institute, Boston, Massachusetts.

Julia Glade-Bender (J)

Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York.

Gary H Lyman (GH)

Clinical Research Division, Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington.

James V Tricoli (JV)

Diagnostic Biomarkers and Technology Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland.

David Patton (D)

Center for Biomedical Informatics and Information Technology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

Stanley R Hamilton (SR)

Department of Pathology, City of Hope National Medical Center, Duarte, California.

Robert J Gray (RJ)

Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Douglas S Hawkins (DS)

Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington.

Bhanumati Ramineni (B)

Cancer Therapy Evaluation Program, Regulatory Affairs Branch, DCTD, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

Keith T Flaherty (KT)

Division of Medical Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts.

Petros Grivas (P)

Department of Medicine, Division of Medical Oncology, University of Washington, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, Washington.

Timothy A Yap (TA)

Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Jordan Berlin (J)

Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.

James H Doroshow (JH)

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.

Lyndsay N Harris (LN)

Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.

Jeffrey A Moscow (JA)

Investigational Drug Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

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