Tests immunotherapy combinations before surgery for early colon cancer
Tests immunotherapy drugs given before surgery in adults with early colon cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
Key facts
- Where
- Amsterdam, Eindhoven, Haarlem, Hilversum, and The Hague, NetherlandsSee the 6 sites
- Phase
- Phase 2
Where in Netherlands
- Marieke van de BeltAmsterdam, NetherlandsTaking people
- OLVGAmsterdam, NetherlandsTaking people
- Catharina ZiekenhuisEindhoven, NetherlandsTaking people
- Spaarne ZiekenhuisHaarlem, NetherlandsTaking people
- TergooiHilversum, NetherlandsNot yet recruiting
- Haga ZiekenhuisThe Hague, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT03026140EU 2024-513314-35-00
- Record updated
- 30 September 2026
- Original description
In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.Read full original descriptionShow less
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)
In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.
Inclusion: 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: No previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1; No radiotherapy prior to or planned post-surgery radiotherapy; 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; No signs of obstruction or macroscopic bleeding or suspicion of perforation; 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 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 signs of distant metastases; 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.