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Screening Clinical Trial Points the Way to Treatments Informed by Genomic Sequencing

Follow-up to NCI’s MATCH study open to children, adults and older adults

A screening clinical trial underway at Roswell Park Comprehensive Cancer Center and other centers across the U.S. will take the next step toward determining the effectiveness of cancer treatments informed by genomic sequencing of the tumor. “We hope the results will help us identify better treatments for patients who have rare cancers or tumors with rare molecular abnormalities,” says Ellis Levine, MD, Chief of Breast Medicine, Department of Medicine at Roswell Park. Dr. Levine serves as site principal investigator of “Targeted Therapy Directed by Genetic Testing in Treating Patients with Locally Advanced or Advanced Solid Tumors, the ComboMATCH Screening Trial” (NCT05564377).

This study represents the second phase of the National Cancer Institute’s pioneering clinical trial Molecular Analysis for Therapy Choice (MATCH), launched in 2015. It is open to children, adults and older adults who have advanced or locally advanced solid tumors that have progressed on at least one line of standard systemic therapy or who do not have a standard treatment option that has been shown to prolong overall survival.

The original MATCH study provided evidence that some patients with advanced disease benefited when genomic sequencing of their tumor samples helped match them to FDA-approved or investigational targeted monotherapies. Eventually, however, they developed resistance to those drugs.

The current clinical trial aims to close the resistance gap by comparing the effectiveness of a targeted monotherapy with targeted combination therapies that include a drug aimed at the mechanism of resistance. The initial “gateway” segment of the clinical trial will use genomic sequencing of patients’ tumor samples to match their specific molecular abnormalities to one of 20 larger phase 2 treatment subprotocols. Combination therapies offered in the subprotocols must previously have shown evidence that both agents were effective in vivo, either clinically or preclinically (including in genetically relevant patient-derived xenografts), resulting in stable disease or better.

Investigators hope the strategy adopted by the study will become the basis for the development of molecularly targeted combination therapies that could provide treatment options for patients who otherwise might have none.

Patients are eligible if they have:

  • Advanced malignant solid neoplasm
  • Anatomic stage 3 breast cancer AJCC v8
  • Anatomic stage 4 breast cancer AJCC v8
  • Locally advanced malignant solid neoplasm
  • Metastatic HER2-negative breast carcinoma
  • Metastatic malignant solid neoplasm
  • Recurrent endometrial carcinoma
  • Recurrent fallopian tube carcinoma
  • Recurrent ovarian carcinoma
  • Recurrent primary peritoneal carcinoma
  • Unresectable HER2-negative breast carcinoma
  • Unresectable malignant solid neoplasm

Projected enrollment for the clinical trial is 2,900 nationwide.

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