The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and the National Cancer Institute (NCI) assembled an Agents and Genes Working Group to review subprotocol concept proposals for NCI-ComboMATCH. Researchers across the NCI Clinical Trials Network (NCTN) were invited to submit high-level concepts following the brief scientific principles listed below. Proposals were general and did not need to be a full design. The concept sheet submission period is now closed.
The review was by four members from each NCTN cooperative group along with additional members with developmental therapeutics and precision oncology expertise. Accepted subprotocols are now being assembled 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 direct questions 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|