Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy

Launched by ONCOATLAS LLC · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain genetic changes in colorectal cancer (CRC) can affect patients' responses to a type of treatment called immune checkpoint inhibitors (ICIs). Colorectal cancer can sometimes have a specific condition known as microsatellite instability (MSI), which is found in about 20% of cases. While ICIs have shown promise in treating MSI-positive CRC, some patients do not respond well, and the researchers want to understand why. They will study blood samples from patients receiving ICIs to see how the MSI status changes over time and what factors might influence treatment outcomes.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of colorectal cancer with verified MSI positivity. Eligible patients should be starting treatment with an immune checkpoint inhibitor soon and must be able to provide blood samples during the treatment. Participants will help researchers gather important information that could lead to better treatment strategies for individuals with MSI-positive colorectal cancer. If you are considering joining, you'll need to provide consent and meet specific health criteria, but you will be helping to advance understanding in this important area of cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer.
• • Verified MSI/dMMR positivity as measured by 5-loci PCR or 4-antibody IHC.
• • The patient is scheduled to start treatment with any of the immune checkpoint inhibitors 2-4 weeks after the inclusion in the study.
• • Have provided an archival tumor tissue sample obtained prior to the start of treatment with immune checkpoint inhibitor(s). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
• • Patient has to be able to provide serial blood samples during the course of treatment, as well as on every follow-up tumor scan.
• • The participant (or legally acceptable representative if applicable) provides written informed consent to participate in the trial.
• • Have measurable disease based on RECIST 1.1.
• • Have adequate organ function.
• Exclusion Criteria:
• • Prior treatment with immune checkpoint inhibitors.
• • For female participants: pregnancy or planned pregnancy.
• • The unavailability of the tumor or serial liquid biopsy samples.