Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease

Launched by M.D. ANDERSON CANCER CENTER · Mar 10, 2025

Keywords

ClinConnect Summary

The Precision-MRD clinical trial is a research study focused on understanding how specific treatments, called biomarker-directed therapies, can help patients with colorectal cancer who have minimal residual disease (MRD). MRD means that even after treatment, there may still be a small amount of cancer left that can’t be seen on scans. This study will monitor patients receiving these targeted therapies, which are chosen by their cancer doctors based on certain characteristics of their tumors.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with a specific type of colorectal cancer. You must also have certain markers in your tumor or blood that can be targeted by the therapies being studied. Participants will receive standard treatments while being observed for how these therapies affect their cancer. It's important to note that this study is not currently recruiting participants, so it will be a while before anyone can join. Overall, this trial aims to gather important information that could improve treatment options for colorectal cancer patients in the future.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Male or female subjects aged \> 18 years.
• • 2. Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
• • 3. Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring \< 10 mm may be permitted at the discretion of the principal investigator.
• • 4. Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D).
• • 5. Positive ctDNA blood test obtained \> 21 days after surgery or last administration of adjuvant therapy.
• • 6. Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +/- anti-CTLA-4 antibody for MMRd/MSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors.
• • Exclusion Criteria
• • 1. Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies
• • 2. Presence of a concurrent malignancy requiring active treatment
• • 3. Inability to provide informed consent
• • 4. Children will not be enrolled in this study
• • 5. Pregnant women will not be enrolled in this study
• • 6. Cognitively Impaired subjects will not be enrolled in this study