[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Solstice Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100654919","phase-2-neoadjuvant-pembrolizumab-and-porustobart-in-resectable-pmmrmss-colon-cancer-100654919",false,"NCT07808151","Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR\u002FMSS Colon Cancer","A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR\u002FMSS Colon Cancer","Inclusion Criteria:\n\n≥18 years of age at consent\n\nAdenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR\u002FMSS status\n\nAny T3 or T4, N any, M0; disease amenable to surgical resection\n\nECOG Performance Status 0-1\n\nAdequate tumor tissue sample with associated pathology report\n\nAdequate hematologic, hepatic, and renal function\n\nReproductive status\u002Fcontraception requirements per protocol\n\nExclusion Criteria:\n\nInvestigational agent within 3 weeks of first dose\n\nImminent or urgent need for surgery\n\nPrior treatment with ICIs targeting CTLA-4, PD-1, or PD-L1\n\nSystemic corticosteroid\u002Fimmunosuppressive therapy within 1 week of first dose (exceptions apply)\n\nHistory of severe hypersensitivity to a fully human mAb; interstitial lung disease; pneumonitis requiring corticosteroids\n\nActive or history of autoimmune disease requiring systemic treatment within 2 years\n\nMajor surgery within 4 weeks of first dose; active infection requiring treatment","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer.\n\nThe main questions this study wants to answer:\n\nHow well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines?\n\nResearchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22).\n\nParticipants will:\n\nComplete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery",[26,27,28],"Colon Cancer","Microsatellite Stable (MSS) Colon Cancer","Proficient Mismatch Repair (pMMR) Colon Cancer",[30,31,32,33,34,35,36,37,38,39,40],"neoadjuvant therapy","Immune checkpoint inhibitor","CTLA-4","PD-1","Porustobart","HBM4003","Pembrolizumab","Major pathologic response","pMMR\u002FMSS colon cancer","Resectable colon cancer","Fc-enhanced CTLA-4","NOT_YET_RECRUITING","2026-09-03",{"date":44,"type":45},"2026-09-08","ACTUAL",{"date":47,"type":20},"2026-09-30",{"date":49,"type":20},"2029-09-30",{"name":51,"class":52},"Solstice Oncology, Inc.","INDUSTRY",30,""]