NCI Requests Letters of Intent for Laboratories to Participate in the NCI-ComboMATCH Clinical Trial

03/19/2020

NCI and the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) are developing NCI-ComboMATCH, a successor precision medicine trial to NCI-MATCH. ComboMATCH will concentrate on targeted drug combination signal-seeking studies supported by preclinical in vivo evidence.

NCI-ComboMATCH trial leadership 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-ComboMATCH trial.

NCI has published two solicitations for the recruitment of CLIA accredited laboratories to support NCI-ComboMATCH:

• Laboratory sites identifying cases from the general population
• Laboratory sites identifying exclusively pediatric cases

These laboratories will join a network of 30 designated laboratories already put in place last year to identify cases for NCI-MATCH. To support ComboMATCH, the designated laboratories will identify patients for the specific gene abnormalities needed for trial eligibility using assays performed as standard-of-care. Laboratories will be required to contact any of the National Clinical Trial Network sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a gene abnormality that would potentially make the patient eligible for one of the treatment arms.

Applicants have until 5:00 PM on June 30, 2020 to submit their letters of intent.

General:

Main site:
https://www.federalregister.gov/documents/2020/03/11/2020-04915/request-for-letters-of-interest-loi-for-nci-match-laboratories

PDF:
https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/2020-04915.pdf

Pediatric:

Main site:
https://www.federalregister.gov/documents/2020/03/11/2020-04916/request-for-letters-of-interest-loi-for-pediatric-focused-nci-match-laboratories

PDF:
https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/2020-04916.pdf