June 28, 2019 Extended Until Further Notice
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), in collaboration with the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN), is developing the successor precision medicine trial to NCI-MATCH (EAY131). The trial is being called ComboMATCH and will concentrate on targeted drug combination signal-seeking studies supported by preclinical in vivo evidence.
ComboMATCH Request for Subprotocol Proposals:
ECOG-ACRIN introduced the concept of ComboMATCH to the wider scientific community on June 2, 2019, at the annual meeting of the American Society of Clinical Oncology (ASCO). Subsequent to this meeting, ECOG-ACRIN is accepting high-level concepts for ComboMATCH subprotocols. Proposals may be general and are not required to be fully designed at this time.
The hypothesis behind this trial is that in vivo evidence, in particular, PDX and cell-line derived xenograft data, can be used to predict the benefit of drug combination therapy in multiple specified patient subgroups.
Like NCI-MATCH (EAY131), ComboMATCH is conceived as a signal-seeking study. To distinguish ComboMATCH from the original NCI-MATCH trial, this study will focus on rational combinations of agents supported by preclinical in vivo evidence.
ComboMATCH is envisioned as having an overall Master Control document, managed by ECOG-ACRIN, that will coordinate four separate NCTN group-specific treatment “cassettes.” Each cassette will have four to six subprotocols. Therefore, the four cassettes, each with up to four to six subprotocols, will be administratively managed by a cooperative group in coordination with ECOG-ACRIN. Like with NCI-MATCH, ComboMATCH hopes to have multiple investigators involved in each arm, with junior and senior investigators and translational researchers.
Subprotocol concept proposals will be reviewed by the ComboMATCH Agents and Genes Working Group (C-AGWG). This will consist of four members from each NCTN cooperative group along with additional members with developmental therapeutics and precision oncology expertise. Accepted subprotocols will be assembled into the different cassettes by this committee in coordination with each of the cooperative groups.
Brief scientific principals:
- Subprotocol proposals must be supported by both a strong scientific rationale and in vivo evidence of efficacy
- Combination therapy proposals are desired. There should be evidence that both agents in the combination are required for efficacy. The proposed need to have safety data available or justification of why a short run-in design may be considered.
- Single arm, sequential or randomized designs can be considered
- Selected monotherapy arms can be considered for agents with strong rationale or preliminary signal of efficacy
- Combinations involving immunotherapy agents are discouraged unless they are supported by pre-clinical models. A separate NCI initiative is being planned that will provide relevant immune-oncology diagnostic support for signal-seeking studies involving immune-oncology agents.
- Combinations with strong preclinical data but lacking safety data can be considered for future arms after safety data is obtained. Such combinations may be referred to the NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN) for phase I study by the C-AGWG.
ECOG-ACRIN requests that members of the NCTN send their ComboMATCH Concept Sheet to the ComboMATCH representative of their respective group, listed below:
|Alliance||Geoff Shapiro||Send an email|
|ECOG-ACRIN||Peter O’Dwyer||Send an email|
|NRG||Roisin O’Cearbhaill||Send an email|
|SWOG||Gary Lyman||Send an email|
Send an email to Erin Mendelsohn, ECOG-ACRIN Project Manager, or call her at 215-399-0428.