[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100243502":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":36,"locations":44,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":25,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Vaccinogen Inc","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"OncoVAX and Surgery","EXPERIMENTAL","Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer",[13,14],"Biological: OncoVAX and Surgery","Procedure: Surgery",{"label":16,"type":17,"description":18,"interventionNames":19},"Surgery","ACTIVE_COMPARATOR","Surgical resection of Stage II colon cancer",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer",[9],null,{"type":27,"name":16,"description":18,"armGroupLabels":28,"otherNames":25},"PROCEDURE",[9,16],[30,33],{"name":31,"affiliation":5,"role":32},"Michael G Hanna, Jr, PhD","STUDY_CHAIR",{"name":34,"affiliation":5,"role":35},"Herbert C. Hoover, MD","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Michael G Hanna, PhD","CONTACT","‪(347) 644-9396","active-trial@vaccinogentx.com",{"name":43,"role":39,"phone":25,"phoneExt":25,"email":25},"LaTonjia S Wallace, MS, MBA",[45],{"facility":46,"status":25,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Halifax Health Medical Center","Port Orange","Florida","32127","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-80.99561,29.13832,{"lat":56,"lon":55},[59,61],{"name":60,"role":39,"phone":25,"phoneExt":25,"email":25},"Ammar Hemaidan, MD",{"name":60,"role":62,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100243502","phase-3-a-multicenter-study-of-active-specific-immunotherapy-with-oncovax-in-patients-with-stage-ii-colon-cancer-100243502",false,"NCT02448173","A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer","A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer","Inclusion Criteria:\n\n* Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.\n* Patients must have undergone curative resection and have no evidence of residual or metastatic disease.\n* Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.\n\nExclusion Criteria:\n\n* Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.\n* Patients with more than one malignant primary colon cancer will be excluded.","ALL","18 Years",{"count":75,"type":76},550,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","OncoVAX® is the first cancer therapy that both prevents cancer recurrence and\n\naddresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase\n\nIIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's\n\nown cancer cells to mobilize the body's immune system to prevent the return of colon\n\ncancer following surgery.",[82],"Stage II Colon Cancer","NOT_YET_RECRUITING","2026-01-29",{"date":86,"type":87},"2026-02-02","ACTUAL",{"date":89,"type":76},"2026-08",{"date":91,"type":76},"2033-08",{"name":5,"class":6},1]