TY - JOUR
T1 - National Cancer Institute Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH)
AU - ComboMATCH study team
AU - Meric-Bernstam, Funda
AU - Ford, James M.
AU - O’Dwyer, Peter J.
AU - Shapiro, Geoffrey I.
AU - McShane, Lisa M.
AU - Freidlin, Boris
AU - O’Cearbhaill, Roisin E.
AU - George, Suzanne
AU - Glade-Bender, Julia
AU - Lyman, Gary H.
AU - Tricoli, James V.
AU - Patton, David
AU - Hamilton, Stanley R.
AU - Gray, Robert J.
AU - Hawkins, Douglas S.
AU - Ramineni, Bhanumati
AU - Flaherty, Keith T.
AU - Grivas, Petros
AU - Yap, Timothy A.
AU - Berlin, Jordan
AU - Doroshow, James H.
AU - Harris, Lyndsay N.
AU - Moscow, Jeffrey A.
N1 - Funding Information:
This work was supported in part by the MD Anderson Cancer Center Support Grant (P30 CA016672) and the UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1 grant (UG1 CA233329). R.E. O’Cearbhaill is funded in part by the NIH/NCI Cancer Center Support Grant P30 CA008748. We thank Amy Ninetto from the MD Anderson Research Medical Library for her editorial assistance and Susanna Brisendine for administrative assistance.
Publisher Copyright:
© 2023 The Authors; Published by the American Association for Cancer Research.
PY - 2023/4
Y1 - 2023/4
N2 - 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.
AB - 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.
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U2 - 10.1158/1078-0432.CCR-22-3334
DO - 10.1158/1078-0432.CCR-22-3334
M3 - Article
C2 - 36662819
AN - SCOPUS:85152593180
SN - 1078-0432
VL - 29
SP - 1412
EP - 1422
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 8
ER -