{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NICHE","nct_id":"NCT03026140","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=niche-nct03026140. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"NICHE","arms":[{"description":"drug: ipilimumab 1 mg/kg day 1 (IV) drug: nivolumab 3 mg/kg on day 1 and day 15 (IV)","label":"group 1 - closed","type":"EXPERIMENTAL"},{"description":"drug: ipilimumab 1 mg/kg day 1 (IV) drug: nivolumab 3 mg/kg on day 1 and day 15 (IV) drug: celecoxib 200 mg daily (oral)","label":"group 2 - closed","type":"EXPERIMENTAL"},{"description":"drug: nivolumab 3 mg/kg day 1 and day 15 (IV) drug: BMS-986253 (anti-IL8) 2400mg on day 1 and day 15 (IV)","label":"Anti-IL8 cohort 4 (pMMR/MSS tumors) - closed","type":"EXPERIMENTAL"},{"description":"drug: nivolumab 240mg IV on day 1 and day 15 drug: relatlimab 240mg IV on day 1 and day 15","label":"Relatlimab cohort 5 (pMMR/MSS tumors)","type":"EXPERIMENTAL"},{"description":"drug: nivolumab 480mg IV on day 1 and day 29 drug: relatlimab 480mg IV on day 1 and day 29","label":"Relatlimab cohort 6 (dMMR/MSI tumors) - closed","type":"EXPERIMENTAL"},{"description":"Patients with dMMR tumors will be treated with 3 cycles of neoadjuvant nivolumab (480mg) + relatlimab (160mg) on day 1, day 29 and day 57 followed by surgery within 12 weeks and not earlier than 10 weeks from enrollment","label":"Cohort 7 - dMMR - 3 cycles neoadjuvant nivolumab + relatlimab - closed","type":"EXPERIMENTAL"},{"description":"Patients with dMMR tumors will be treated with 3 cycles of neoadjuvant nivolumab (480mg) on day 1, day 29 and day 57 followed by surgery within 12 weeks and not earlier than 10 weeks from enrollment.","label":"Cohort 8 - dMMR - 3 cycles neoadjuvant nivolumab - closed","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2032-03-01","type":"ESTIMATED"},"conditions":["Colon Carcinoma"],"enrollment":{"count":353,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Nivolumab","otherNames":["nivolumab (opdivo)"],"type":"DRUG"},{"name":"Ipilimumab","otherNames":["Ipilimumab (Yervoy)"],"type":"DRUG"},{"name":"Celecoxib 200mg","otherNames":["Celebrex"],"type":"DRUG"},{"name":"BMS-986253","otherNames":["Anti-IL8"],"type":"DRUG"},{"name":"Relatlimab (BMS-986016)","otherNames":["Relatlimab"],"type":"DRUG"}],"last_update":"2026-09-30","lead_sponsor":"The Netherlands Cancer Institute","official_title":"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)","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2032-03-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of adverse events during the treatment and follow-up (safety)","timeFrame":"until 100 days after last patient last study drug treatment"},{"measure":"Disease free survival","timeFrame":"until 5 years after diagnosis"},{"measure":"Major Pathological Response","timeFrame":"From date of randomization until the date of first documented progression, assessed up to 63 months"}],"references":[{"citation":"Tan PB, Verschoor YL, van den Berg JG, Balduzzi S, Kok NFM, Ijsselsteijn ME, Moore K, Jurdi A, Tin A, Kaptein P, van Leerdam ME, Haanen JBAG, Voest EE, de Miranda NFCC, Schumacher TN, Wessels LFA, Chalabi M. Neoadjuvant immunotherapy in mismatch-repair-proficient colon cancers. Nature. 2025 Dec;648(8094):726-735. doi: 10.1038/s41586-025-09679-4. Epub 2025 Oct 20.","pmid":"41115454","type":"DERIVED"},{"citation":"de Gooyer PGM, Verschoor YL, van den Dungen LDW, Balduzzi S, Marsman HA, Geukes Foppen MH, Grootscholten C, Dokter S, den Hartog AG, Verbeek WHM, Woensdregt K, van den Broek JJ, Oosterling SJ, Schumacher TN, Kuhlmann KFD, Beets-Tan RGH, Haanen JBAG, van Leerdam ME, van den Berg JG, Chalabi M. Neoadjuvant nivolumab and relatlimab in locally advanced MMR-deficient colon cancer: a phase 2 trial. Nat Med. 2024 Nov;30(11):3284-3290. doi: 10.1038/s41591-024-03250-w. Epub 2024 Sep 15.","pmid":"39278994","type":"DERIVED"},{"citation":"Cercek A. Neoadjuvant Treatment of Mismatch Repair-Deficient Colon Cancer - Clinically Meaningful? N Engl J Med. 2024 Jun 6;390(21):2024-2025. doi: 10.1056/NEJMe2404601. No abstract available.","pmid":"38838316","type":"DERIVED"},{"citation":"Chalabi M, Verschoor YL, Tan PB, Balduzzi S, Van Lent AU, Grootscholten C, Dokter S, Buller NV, Grotenhuis BA, Kuhlmann K, Burger JW, Huibregtse IL, Aukema TS, Hendriks ER, Oosterling SJ, Snaebjornsson P, Voest EE, Wessels LF, Beets-Tan RG, Van Leerdam ME, Schumacher TN, van den Berg JG, Beets GL, Haanen JB. Neoadjuvant Immunotherapy in Locally Advanced Mismatch Repair-Deficient Colon Cancer. N Engl J Med. 2024 Jun 6;390(21):1949-1958. doi: 10.1056/NEJMoa2400634.","pmid":"38838311","type":"DERIVED"},{"citation":"Wang D, Cabalag CS, Clemons NJ, DuBois RN. Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer. Gastroenterology. 2021 Dec;161(6):1813-1829. doi: 10.1053/j.gastro.2021.09.059. Epub 2021 Oct 2.","pmid":"34606846","type":"DERIVED"},{"citation":"Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.","pmid":"32251400","type":"DERIVED"}],"start_date":{"date":"2017-03-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer","url":"https://clinicaltrials.gov/study/NCT03026140"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/niche-nct03026140"}