[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287781":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":74,"centralContacts":79,"locations":86,"responsibleParty":154,"collaborators":156,"id":160,"slug":90,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":90,"enrollmentInfo":169,"targetDuration":90,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":88,"whyStopped":90,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8,15,20,25,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"group 1 - closed","EXPERIMENTAL","drug: ipilimumab 1 mg\u002Fkg day 1 (IV) drug: nivolumab 3 mg\u002Fkg on day 1 and day 15 (IV)",[13,14],"Drug: Nivolumab","Drug: Ipilimumab",{"label":16,"type":10,"description":17,"interventionNames":18},"group 2 - closed","drug: ipilimumab 1 mg\u002Fkg day 1 (IV) drug: nivolumab 3 mg\u002Fkg on day 1 and day 15 (IV) drug: celecoxib 200 mg daily (oral)",[13,14,19],"Drug: Celecoxib 200mg",{"label":21,"type":10,"description":22,"interventionNames":23},"Anti-IL8 cohort 4 (pMMR\u002FMSS tumors) - closed","drug: nivolumab 3 mg\u002Fkg day 1 and day 15 (IV) drug: BMS-986253 (anti-IL8) 2400mg on day 1 and day 15 (IV)",[13,24],"Drug: BMS-986253",{"label":26,"type":10,"description":27,"interventionNames":28},"Relatlimab cohort 5 (pMMR\u002FMSS tumors)","drug: nivolumab 240mg IV on day 1 and day 15 drug: relatlimab 240mg IV on day 1 and day 15",[13,29],"Drug: BMS-986016",{"label":31,"type":10,"description":32,"interventionNames":33},"Relatlimab cohort 6 (dMMR\u002FMSI tumors) - closed","drug: nivolumab 480mg IV on day 1 and day 29 drug: relatlimab 480mg IV on day 1 and day 29",[13,29],{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort 7 - dMMR - 3 cycles neoadjuvant nivolumab + relatlimab","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",[13,29],{"label":39,"type":10,"description":40,"interventionNames":41},"Cohort 8 - dMMR - 3 cycles neoadjuvant nivolumab - closed","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.",[13],[43,50,56,62,68],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Nivolumab","Nivolumab 3mg\u002Fkg (day 1 and day 15), administered neoadjuvant before surgery",[21,35,39,26,31,9,16],[49],"nivolumab (opdivo)",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Ipilimumab","Ipilimumab 1 mg\u002Fkg (day 1) ,administered neoadjuvant before surgery",[9,16],[55],"Ipilimumab (Yervoy)",{"type":44,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Celecoxib 200mg","celecoxib will be administered starting day 1 until 1 day before surgery daily (if patient is randomized to group 2 (only applicable for patients with a MSS tumor)",[16],[61],"Celebrex",{"type":44,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"BMS-986253","BMS-986253 2400mg IV will be administered on day 1 and 15 (only applicable for patients with MSS tumors)",[21],[67],"Anti-IL8",{"type":44,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"BMS-986016","Relatlimab will be administered IV, in cohort 5 240mg on day 1 and day 15, in cohort 6 480mg on day 1 and day 29, in cohort 7 160mg on day 1, day 29 and day 57",[35,26,31],[73],"Relatlimab",[75],{"name":76,"affiliation":77,"role":78},"Myriam Chalabi, MD","Antoni van Leeuwenhoek","PRINCIPAL_INVESTIGATOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":84,"email":85},"Marieke van de Belt","CONTACT","+3120512","1926","m.vd.belt@nki.nl",[87,101,109,120,131,143],{"facility":81,"status":88,"city":89,"state":90,"zip":91,"country":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"RECRUITING","Amsterdam",null,"1066CX","Netherlands",{"type":94,"coordinates":95},"Point",[96,97],4.88969,52.37403,{"lat":97,"lon":96},[100],{"name":81,"role":82,"phone":83,"phoneExt":84,"email":85},{"facility":102,"status":88,"city":89,"state":90,"zip":90,"country":92,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"OLVG",{"type":94,"coordinates":104},[96,97],{"lat":97,"lon":96},[107],{"name":108,"role":82,"phone":90,"phoneExt":90,"email":90},"A van Lent",{"facility":110,"status":88,"city":111,"state":90,"zip":90,"country":92,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Catharina Ziekenhuis","Eindhoven",{"type":94,"coordinates":113},[114,115],5.47778,51.44083,{"lat":115,"lon":114},[118],{"name":119,"role":82,"phone":90,"phoneExt":90,"email":90},"P Burger",{"facility":121,"status":88,"city":122,"state":90,"zip":90,"country":92,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Spaarne Ziekenhuis","Haarlem",{"type":94,"coordinates":124},[125,126],4.63683,52.38084,{"lat":126,"lon":125},[129],{"name":130,"role":82,"phone":90,"phoneExt":90,"email":90},"S Oosterling",{"facility":132,"status":133,"city":134,"state":90,"zip":90,"country":92,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Tergooi","NOT_YET_RECRUITING","Hilversum",{"type":94,"coordinates":136},[137,138],5.17639,52.22333,{"lat":138,"lon":137},[141],{"name":142,"role":82,"phone":90,"phoneExt":90,"email":90},"E. Hendriks",{"facility":144,"status":133,"city":145,"state":90,"zip":90,"country":92,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Haga ziekenhuis","The Hague",{"type":94,"coordinates":147},[148,149],4.29861,52.07667,{"lat":149,"lon":148},[152],{"name":153,"role":82,"phone":90,"phoneExt":90,"email":90},"T Aukema",{"type":155,"investigatorFullName":90,"investigatorTitle":90,"investigatorAffiliation":90,"oldNameTitle":90,"oldOrganization":90},"SPONSOR",[157],{"name":158,"class":159},"Bristol-Myers Squibb","INDUSTRY","100287781",false,"NCT03026140","Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in 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)","NICHE","Inclusion criteria:\n\n* Signed written informed consent\n* Patients at least 18 years of age\n* Non-metastatic adenocarcinoma of the colon (and rectosigmoid considered as nonrectal and not undergoing neoadjuvant treatment)\n\n  * No signs of distant metastases on CT-scan and physical examination;\n  * dMMR cohorts 3+6: \\>cT3 and\u002For N+\n\nExclusion criteria:\n\n* No signs of distant metastases\n* No signs of obstruction or macroscopic bleeding or suspicion of perforation\n* Colonoscopy must be performed after registration to obtain study-specific biopsies. If biopsies are not possible, patients cannot be included in the study\n* WHO performance status of 0 or 1\n* No previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1\n* 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\u002For cerebrovascular disease\n* No radiotherapy prior to or planned post-surgery radiotherapy\n* 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)\n* No intercurrent illnesses, including but not limited to infections, unstable angina pectoris\n* No positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection\n* No autoimmune disease\n* 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\n* No live vaccines in the 4 weeks prior to inclusion","ALL","18 Years",{"count":170,"type":171},353,"ESTIMATED","INTERVENTIONAL",[174],"PHASE2","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.",[177],"Colon Carcinoma",[179,180,181,182,183,184,185,67,73,186],"MSI tumors","MSS tumors","short-term immunotherapy","surgical resection","nivolumab","ipilimumab","COX2","Anti-LAG3","2026-03-03",{"date":189,"type":190},"2026-03-05","ACTUAL",{"date":192,"type":190},"2017-03-29",{"date":194,"type":171},"2032-03-01",{"name":5,"class":6},6]