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NCI-MATCH (EAY131) Trial Update

NCI-MATCH crowd silhouettes

A series of changes were recently incorporated in NCI-MATCH (EAY131) addendum #24. First, two new correlative proposals, CS-MATCH-0014ctR and CS-MATCH-0015ctR, were adapted into appendices for the master protocol. Second, revisions were implemented for multiple pre-existing subprotocols (approximately 17 treatment arms), including the following: modifications to improve slow accruing arms--aMOI (actionable mutation of interest) additions; expansion of arms EAY131-C1 (15), H (50), M (14), and Z1C (14) with justification; modifications to affected subprotocols to account for the copy number amplification threshold; adaptation of new correlative proposal CS­ MATCH-0012 into appendices for subprotocol EAY131-Q; revisions to the immunohistochemistry (IHC) enrollment process, affecting subprotocols EAY131-Z1G and Z1H; and RRAs for trametinib, dabrafenib, and palbociclib affecting arms EAY131-H, R, S1, S2, and Z1C.

Additionally, both orthogonal assay language and nucleic acid language were added to the master screening document, as well as revised novel inclusionary and exclusionary aMOI language. Finally, minor administrative edits were made throughout the master and screening consent documents.

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