[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287781":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":74,"centralContacts":79,"locations":86,"responsibleParty":155,"collaborators":157,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":163,"sex":169,"minAge":170,"maxAge":90,"enrollmentInfo":171,"targetDuration":90,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":88,"whyStopped":90,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"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",[87,102,110,121,132,144],{"facility":81,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"RECRUITING","Amsterdam",null,"1066CX","Netherlands","NL",{"type":95,"coordinates":96},"Point",[97,98],4.88969,52.37403,{"lat":98,"lon":97},[101],{"name":81,"role":82,"phone":83,"phoneExt":84,"email":85},{"facility":103,"status":88,"city":89,"state":90,"zip":90,"country":92,"countryCode":93,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"OLVG",{"type":95,"coordinates":105},[97,98],{"lat":98,"lon":97},[108],{"name":109,"role":82,"phone":90,"phoneExt":90,"email":90},"A van Lent",{"facility":111,"status":88,"city":112,"state":90,"zip":90,"country":92,"countryCode":93,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Catharina Ziekenhuis","Eindhoven",{"type":95,"coordinates":114},[115,116],5.47778,51.44083,{"lat":116,"lon":115},[119],{"name":120,"role":82,"phone":90,"phoneExt":90,"email":90},"P Burger",{"facility":122,"status":88,"city":123,"state":90,"zip":90,"country":92,"countryCode":93,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Spaarne Ziekenhuis","Haarlem",{"type":95,"coordinates":125},[126,127],4.63683,52.38084,{"lat":127,"lon":126},[130],{"name":131,"role":82,"phone":90,"phoneExt":90,"email":90},"S Oosterling",{"facility":133,"status":134,"city":135,"state":90,"zip":90,"country":92,"countryCode":93,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Tergooi","NOT_YET_RECRUITING","Hilversum",{"type":95,"coordinates":137},[138,139],5.17639,52.22333,{"lat":139,"lon":138},[142],{"name":143,"role":82,"phone":90,"phoneExt":90,"email":90},"E. Hendriks",{"facility":145,"status":134,"city":146,"state":90,"zip":90,"country":92,"countryCode":93,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Haga ziekenhuis","The Hague",{"type":95,"coordinates":148},[149,150],4.29861,52.07667,{"lat":150,"lon":149},[153],{"name":154,"role":82,"phone":90,"phoneExt":90,"email":90},"T Aukema",{"type":156,"investigatorFullName":90,"investigatorTitle":90,"investigatorAffiliation":90,"oldNameTitle":90,"oldOrganization":90},"SPONSOR",[158],{"name":159,"class":160},"Bristol-Myers Squibb","INDUSTRY","100287781","phase-2-neoadjuvant-immune-checkpoint-inhibition-and-novel-io-combinations-in-early-stage-colon-cancer-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":172,"type":173},353,"ESTIMATED","INTERVENTIONAL",[176],"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.",[179],"Colon Carcinoma",[181,182,183,184,185,186,187,67,73,188],"MSI tumors","MSS tumors","short-term immunotherapy","surgical resection","nivolumab","ipilimumab","COX2","Anti-LAG3","2026-03-03",{"date":191,"type":192},"2026-03-05","ACTUAL",{"date":194,"type":192},"2017-03-29",{"date":196,"type":173},"2032-03-01",{"name":5,"class":6},6]