[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasms-colon\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasms-colon":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100559718","phase-2-a-study-of-neoadjuvant-dostarlimab-plus-capecitabine-plus-oxaliplatin-capeox-vs-capeox-with-previously-untreated-t4n0-or-stage-iii-mismatch-repair-proficient-mmrpmicrosatellite-stable-mss-colon-cancer-100559718",false,"NCT06567782","A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)\u002FMicrosatellite Stable (MSS) Colon Cancer","A Phase 2, Open Label, Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp\u002F MSS Colon Cancer","AZUR-4","Inclusion Criteria:\n\n* Has untreated pathologically confirmed colon adenocarcinoma\n* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III\n* Has a tumor demonstrating the presence of either-\n\n  1. MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp; MMR status may be determined local laboratory; or\n  2. MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory\n* Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required\n* Is willing to use adequate contraception male and\u002For female participants\n* Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has distant metastatic disease\n* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer\n* Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery\n* Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade \\[Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome\\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary\n* Has any history of interstitial lung disease or immune-related pneumonitis\n* Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator\n* Is considered, in investigator's opinion, a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy\n* Has received treatment with an investigational agent within \\[4 weeks\\] of the first dose of study intervention\n* Is pregnant or breastfeeding\n* Has a history of severe allergic and\u002For anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of CAPEOX","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main goal of this study is to test a new treatment approach for colon cancer. The treatment involves dostarlimab along with a specific type of chemotherapy called CAPEOX (short for \"capecitabine + oxaliplatin\") to check if using these two together works better than using just CAPEOX by itself. This treatment is given before any surgery takes place; a method referred to as \"neoadjuvant therapy.\" . The aim is to see if this new approach can show early signs of effectiveness in treating participants with a specific type of colon cancer known as mismatch repair proficient\u002F microsatellite stable (MMRp\u002FMSS), where the cells have normal repair systems and stable DNA sequences. This study will also look at specific signs in the blood and tumor to see if they can help predict how well the treatment is working. This could help better understand how dostarlimab contributes to the response of the disease to treatment.",[27],"Neoplasms, Colon",[29,30,31,32,33,34,35,36,37,38],"Colon cancer","MMRp","MSS","Dostarlimab","CAPEOX","Neoadjuvant","GSK4057190A","TSR-042","Chemotherapy","Immunotherapy","RECRUITING","2026-05-21",{"date":42,"type":43},"2026-05-22","ACTUAL",{"date":45,"type":43},"2025-02-18",{"date":47,"type":21},"2028-10-26",{"name":49,"class":50},"GlaxoSmithKline","INDUSTRY",33,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100504966","phase-3-study-of-perioperative-dostarlimab-in-participants-with-untreated-t4n0-or-stage-iii-dmmrmsi-h-resectable-colon-cancer-100504966","NCT05855200","Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR\u002FMSI-H Resectable Colon Cancer","A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR\u002FMSI-H Resectable Colon Cancer","Inclusion Criteria:\n\n* Has untreated pathologically confirmed colon adenocarcinoma\n* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III\n* Has radiologically evaluable disease\n* Has a tumor demonstrating the presence of either dMMR status or MSI-H\n\nExclusion Criteria:\n\n* Has distant metastatic disease.\n* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer\n* Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent\u002Femergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.\n* Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization\n* Has any history of interstitial lung disease or pneumonitis and\u002For history of radiation induced enteritis.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice\n* Has a history of allogenic stem cell transplantation or organ transplantation\n* Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention\n* Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study\n* Has a history of severe allergic and\u002For anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX",{"count":60,"type":21},892,[62],"PHASE3","The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair\u002F microsatellite instability high (dMMR\u002FMSI-H) colon cancer.",[65,27],"Colonic Neoplasms",[67,32,68,36,35,69,33,70,71,72,73,34,74],"JEMPERLI","dostarlimab-gxly","FOLFOX","Colon Cancer","Resectable colon cancer","dMMR\u002FMSI","Perioperative","Adjuvant","2026-01-22",{"date":77,"type":43},"2026-01-23",{"date":79,"type":43},"2023-08-01",{"date":81,"type":21},"2031-03-27",{"name":49,"class":50},266]