Evaluating the effects of immune checkpoint inhibitors on colorectal cancer genetics
A Multi-center Observational Clinical Trial Evaluating the Dynamics of Microsatellite Instability and Genomic Profile of Colorectal Cancer in the Course of Treatment With Immune Checkpoint Inhibitors
This study is testing how treatment with immune checkpoint inhibitors affects the genetics of colorectal cancer in patients with specific tumor types to see if it helps improve their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OncoAtlas LLC Industry-sponsored |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT06414304 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to assess how microsatellite instability (MSI) and genomic profiles of colorectal cancer (CRC) change during treatment with immune checkpoint inhibitors (ICI). Patients with confirmed MSI/dMMR-positive tumors will provide tumor and blood samples before and during treatment. The study will analyze these samples using advanced genomic sequencing techniques to correlate changes in MSI and genomic profiles with treatment outcomes. Imaging methods will be used to evaluate disease response based on established criteria.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed colorectal cancer who have MSI/dMMR-positive tumors and are scheduled to start ICI treatment.
Not a fit: Patients who have previously received immune checkpoint inhibitors or do not have measurable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify biomarkers that predict patient responses to immune checkpoint inhibitors in colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches in understanding the dynamics of tumor genetics during immunotherapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow and 1 other locations
- N.N.Blokhin National Medical Research Center of Oncology — Moscow, Russian Federation (Recruiting)
- State Budgetary Institution of Healthcare of the City of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Health of the City of Moscow — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Maxim Ivanov, PhD — OncoAtlas LLC
- Study coordinator: Maxim Ivanov, PhD
- Email: maxim.ivanov@oncoatlas.ru
- Phone: +7 909 677-52-74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.