[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539178":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":78,"collaborators":80,"id":84,"slug":43,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":43,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":43,"enrollmentInfo":91,"targetDuration":43,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":65,"whyStopped":43,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Botensilimab and Balstilimab","EXPERIMENTAL","Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.",[13,14],"Drug: Botensilimab","Drug: Balstilimab",{"label":16,"type":10,"description":17,"interventionNames":18},"Botensilimab, Balstilimab, and AGEN1423","Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. On the same day as each balstilimab infusion, participants will also receive AGEN1423 infusions, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab + AGEN1423 infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.",[13,14,19],"Drug: AGEN1423",{"label":21,"type":10,"description":22,"interventionNames":23},"Botensilimab, Balstilimab, and Radiation","Participants will receive 3 doses of radiation prior to surgery. Additionally, two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.",[13,14,24],"Radiation: Radiation",[26,33,39,44],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Botensilimab","75 mg IV Q6W",[9,16,21],[32],"AGEN1181",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Balstilimab","450 mg IV Q3W",[9,16,21],[38],"AGEN2034",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"AGEN1423","30 mg\u002Fkg IV Q3W",[16],null,{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":43},"RADIATION","Radiation","8Gy x 3 between Day 0 - 18; Allowed techniques for radiation are 3D conformal, intensity modulated radiotherapy (IMRT), or SBRT",[21],[50],{"name":51,"affiliation":5,"role":52},"Manish Shah, M.D.","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":43,"email":58},"Casey Owens","CONTACT","646-962-6046","cdo4001@med.cornell.edu",{"name":60,"role":56,"phone":43,"phoneExt":43,"email":61},"Myriam Elizaire-Williams","mye4001@med.cornell.edu",[63],{"facility":64,"status":65,"city":66,"state":66,"zip":67,"country":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Weill Cornell Medicine\u002FNewYork-Presbyterian Hospital","RECRUITING","New York","10065","United States",{"type":70,"coordinates":71},"Point",[72,73],-74.00597,40.71427,{"lat":73,"lon":72},[76,77],{"name":55,"role":56,"phone":57,"phoneExt":43,"email":58},{"name":60,"role":56,"phone":43,"phoneExt":43,"email":61},{"type":79,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[81],{"name":82,"class":83},"Agenus Inc.","INDUSTRY","100539178",false,"NCT06300463","Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","Inclusion Criteria:\n\n* Diagnosis of metastatic colorectal adenocarcinoma with liver metastases\n* Participant must be planning to undergo a surgical resection of their liver metastases.\n* Tumor is non-MSI-H\u002FdMMR\n* Presence of measurable disease\n* Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes\n* Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study\n* Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.\n\nExclusion Criteria:\n\n* Not eligible for surgery\n* Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.\n* Previous allogeneic tissue\u002Forgan transplant\n* Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents\n* Participants must not have any contraindications to immune checkpoint inhibitors\n* Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed","ALL","18 Years",{"count":92,"type":93},24,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:\n\n* whether these combinations of immunotherapy change the tumor microenvironment in the liver\n* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases\n\nParticipants will be randomly assigned to one of the following:\n\n* Botensilimab and balstilimab\n* Botensilimab, balstilimab, and AGEN1423\n* Botensilimab, balstilimab, and radiation\n\nParticipants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.",[99,100,101],"Colorectal Cancer Metastatic","Liver Metastases","Colorectal Cancer",[28,34,103],"Immunotherapy","2026-05-13",{"date":106,"type":107},"2026-05-15","ACTUAL",{"date":109,"type":107},"2024-03-26",{"date":111,"type":93},"2027-12",{"name":5,"class":6},1]