The National Cancer Institute (NCI) in collaboration with the NCI Molecular Analysis for Therapy Choice (MATCH) trial leadership (NCT 02465060) invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next Generation Sequencing (NGS) assays to participate in the NCI MATCH trial. The NCI MATCH trial has implemented a new process for identifying patients for arms with rare variant eligibility criteria. Laboratories will contact any of the approximately 1100 sites that have activated NCI MATCH if a specimen sent from one of these sites has a rare variant that would potentially make the patient eligible for one of the treatment arms open in this initiative.
NCI-MATCH aims to establish whether patients with tumor mutations, amplifications or translocations in one of the genetic pathways of interest are likely to derive clinical benefit (primary objective: Objective response; secondary objective: Progression-free survival of at least 6 months) if treated with agents targeting that specific pathway in a single-arm design (see current arms below).
Patients with histologically documented solid tumors, lymphomas and multiple myeloma whose disease has progressed following at least one line of standard systemic therapy or for whom no standard therapy exists are eligible if they meet the eligibility criteria for the trial. Further information about the NCI-MATCH trial may be found at http://ecog-acrin.org/trials/nci-match-eay131.
The selected collaborating laboratories may only act (i.e., refer patients) on any of the rare variant arms for which their assay reports actionable mutations of interest (aMOIs). The assay must also report all exclusionary variants for the arm unless these occur at a frequency of >1% in cancer patients.
CLIA accredited/certified laboratories located in the United States may be Start Printed Page 35977considered for addition to the laboratory network.
More information is available via the Federal Register notice.