The following article features coverage from the American Association for Cancer Research (AACR) 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Researchers at the American Association for Cancer Research (AACR) Annual Meeting 2019 described the rationale for, and design of, a screening protocol to identify patients for enrollment in the upcoming Colorectal and Liquid Biopsy Molecularly Assigned Therapy (COLOMATE) trial.

Although the use of circulating cell-free tumor DNA (cfDNA) next-generation sequencing (NGS) has shown promise in retrospective case studies and/or correlative studies for the detection of potentially actionable genomic targets in colorectal cancer, there is a dearth of prospective evidence to support its utility in assigning molecularly targeted therapy.

The upcoming phase 2 COLOMATE umbrella trial will use the genomic profiling Guardant360 NGS assay, a plasma-based assay of more than 70 genes, to detect colorectal tumor cfDNA in order to assign patients with advanced colorectal cancer to specific targeted treatment arms based on the molecular profiles of their tumors.

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Although not yet open for enrollment (according to ClinicalTrials.gov; Identifier: NCT03765736), patients eligible for the COLOMATE trial, which is being conducted by Academic and Community Cancer Research United, will include adults aged 18 years or older who have a diagnosis of colon or rectal cancer that is metastatic and/or unresectable.

Furthermore, eligible patients must have a contraindication to, been unable to tolerate, or experienced progressive disease following, prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, antivascular endothelial growth factor (VEGF) monoclonal antibodies, and antiepidermal growth factor receptor (EGFR) monoclonal antibodies if they have disease characterized as RAS wild-type.

Patients with specific actionable genomic alterations will be enrolled in specific study arms under the COLOMATE umbrella depending upon the alteration identified. These “companion arms” are under active development and will include arms for patients with disease characterized as RAS/BRAF wild-type, HER2-amplified, FGFR-altered, and RAS-mutated, among others.

The primary objectives of the COLOMATE trial are “to perform blood-based genomic profiling on patients with treatment-refractory metastatic colorectal cancer to facilitate accrual to molecularly assigned therapies, and to obtain tumor tissue and patient-matched tumor DNA from peripheral blood to facilitate clinically annotated genomic analyses.”  Correlative research objectives are “to explore mechanisms of acquired resistance to molecularly assigned therapy, and to explore the correlation between cfDNA mutational burden (allele frequency, copy number) and clinical outcomes such as objective response rate, progression-free survival, and overall survival.”

Disclosure: Some of the presenters disclosed financial ties to pharmaceutical companies. For a full list of disclosures, please see the original abstract.

Read more of Cancer Therapy Advisor‘s coverage of AACR 2019 meeting by visiting the conference page.

Reference

  1. Ciombor KK, Ou F-S, Dodge A, et al. COLOMATE: Colorectal cancer and liquid biopsy screening protocol for molecularly assigned therapy. Presented at: American Association for Cancer Research (AACR) Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. Abstract LB235/14.