Molecular Analysis for Combination Therapy Choice (ComboMATCH)
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Krishnan, Mridula
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05564377?term=NCT05564377&rank=1#participation-criteria
Summary
Primary Objectives
-To register, allocate, and assign patients to ComboMATCH Treatment Trials.
Secondary Objectives
-To evaluate the rate of positive outcomes in defined cohorts within treatment trials of treatment combinations including targeted therapies for molecularly defined populations, and also in the subset of treatment trials where the treatments are supported by in vivo models. -To perform quality control of the patients registered in the form of pathological confirmation of disease and sub-type to confirm diagnosis and treatment arm allocation.
Secondary Correlative Objectives
-Assess the concordance of the central molecular characterization of the pre-treatment biopsy samples with the genetic readouts from the Designated Laboratories (DLs) for patients enrolled on the ComboMATCH Treatment Trials.
-To assess how the registration diagnostic tumor mutation profile and pre-treatment biopsy profile compare to the ctDNA mutation profile from plasma.
Exploratory Objectives
-Assess association between ComboMATCH Treatment Trials outcomes (positive or negative) with the type of rationale for the selected drug combinations (described in Section 1.6) and the type of rationale for the gene variant/combination for selection (described in Section 1.7 (e.g., whether the trial was based on targeted therapies for molecularly defined populations, those that were supported by in vivo models, and those that were supported by empiric clinical data).