Short-term immunotherapy for early-stage colon cancer
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)
This study is testing a new short-term immunotherapy treatment for early-stage colon cancer to see if it can help patients stay cancer-free after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 353 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | prednisone, immunotherapy, ipilimumab, nivolumab, relatlimab |
| Locations | 6 sites (Amsterdam and 5 other locations) |
| Trial ID | NCT03026140 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to treat patients with stage 1-3 adenocarcinoma of the colon using short-term immunotherapy combined with novel immune-oncology agents before surgical resection. The study will enroll 100 patients, including those with microsatellite stable (MSS) and microsatellite instability (MSI) tumors, and will evaluate the effectiveness of various treatment combinations over approximately six weeks. Patients will receive either nivolumab and ipilimumab alone or in combination with other agents like celecoxib or anti-IL8. The primary endpoint is to assess the 3-year disease-free survival for the MSI cohort.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with non-metastatic adenocarcinoma of the colon or rectosigmoid.
Not a fit: Patients with distant metastases or those who have previously received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve disease-free survival rates in patients with early-stage colon cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in treating colon cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Signed written informed consent * Patients at least 18 years of age * Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as nonrectal and not undergoing neoadjuvant treatment) * No signs of distant metastases on CT-scan and physical examination; * dMMR cohorts 3+6: \>cT3 and/or N+ Exclusion criteria: * No signs of distant metastases * No signs of obstruction or macroscopic bleeding or suspicion of perforation * Colonoscopy must be performed after registration to obtain study-specific biopsies. If biopsies are not possible, patients cannot be included in the study * WHO performance status of 0 or 1 * No previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1 * For patients with MSS tumors: no current use of NSAIDs or COX2-inhibitors at registration and no active peptic ulcer, gastrointestinal bleeding, unstable ischemic heart disease of thrombus etiology or significant established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease * No radiotherapy prior to or planned post-surgery radiotherapy * No history of allergy to study drug components, severe hypersensitivity reaction to any monoclonal antibody, allergy or severe hypersensitivity to NSAIDs or COX2-I (MSS tumors) * No intercurrent illnesses, including but not limited to infections, unstable angina pectoris * No positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * No autoimmune disease * No conditions requiring systemic treatment with either corticosteroids (10 mg daily prednisone or more and equivalents) or other immunosuppressive medications within 14 days of study drug administration * No live vaccines in the 4 weeks prior to inclusion
Where this trial is running
Amsterdam and 5 other locations
- Marieke van de Belt — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Spaarne Ziekenhuis — Haarlem, Netherlands (Recruiting)
- Tergooi — Hilversum, Netherlands (Not_yet_recruiting)
- Haga ziekenhuis — The Hague, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Myriam Chalabi, MD — Antoni van Leeuwenhoek
- Study coordinator: Marieke van de Belt
- Email: m.vd.belt@nki.nl
- Phone: +3120512
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.