NCI-ComboMATCH / EAY191 RFP
Request for Subprotocol Proposals
Submission: ECOG-ACRIN is accepting NCI-ComboMATCH concept sheets until further notice
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and the National Cancer Institute (NCI) are developing NCI-ComboMATCH, a successor to the NCI-MATCH / EAY131 precision medicine trial. NCI-ComboMATCH will concentrate on targeted drug combination signal-seeking studies supported by preclinical in vivo evidence.
ECOG-ACRIN introduced the concept of NCI-ComboMATCH to the broader scientific community on June 2, 2019, at the annual meeting of the American Society of Clinical Oncology (ASCO). After this meeting, ECOG-ACRIN began accepting high-level concepts for NCI-ComboMATCH subprotocols. Proposals may be general and do not need to be a full design.
The NCI-ComboMATCH Agents and Genes Working Group (C-AGWG) will review the subprotocol concept proposals. The review will be by 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 Principles
- 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. Proposals 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 preclinical 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 Experimental Therapeutics Clinical Trials Network (ETCTN) for phase I study by the C-AGWG.
ECOG-ACRIN requests that members of the NCTN send their NCI-ComboMATCH Concept Sheet to the NCI-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.