[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407815":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":287,"collaborators":28,"id":289,"slug":290,"hasResults":291,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":28,"eligibilityCriteria":295,"healthyVolunteers":291,"sex":296,"minAge":297,"maxAge":28,"enrollmentInfo":298,"targetDuration":28,"studyType":301,"phases":302,"briefSummary":305,"conditions":306,"keywords":311,"overallStatus":61,"whyStopped":28,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Module 1","EXPERIMENTAL","REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab",[13,14,15],"Drug: REGN5668","Drug: Cemiplimab","Drug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]",{"label":17,"type":10,"description":18,"interventionNames":19},"Module 2","REGN5668 and ubamatamab",[13,20,21],"Drug: Ubamatamab","Drug: Sarilumab",[23,29,35,40,45],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","REGN5668","Administer per the protocol",[9,17],null,{"type":24,"name":30,"description":26,"armGroupLabels":31,"otherNames":32},"Cemiplimab",[9],[33,34],"REGN2810","Libtayo®",{"type":24,"name":36,"description":26,"armGroupLabels":37,"otherNames":38},"Ubamatamab",[17],[39],"REGN4018",{"type":24,"name":41,"description":26,"armGroupLabels":42,"otherNames":43},"Sarilumab",[17],[44],"Kevzara®",{"type":24,"name":46,"description":26,"armGroupLabels":47,"otherNames":28},"Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]",[9],[49],{"name":50,"affiliation":5,"role":51},"Clinical Trial Management","STUDY_DIRECTOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":28,"email":57},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[59,73,82,91,102,112,118,128,134,144,153,163,173,183,195,207,217,227,237,246,258,267,276,281],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":28},"City of Hope Comprehensive Cancer Center","RECRUITING","Duarte","California","91010","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-117.97729,34.13945,{"lat":71,"lon":70},{"facility":74,"status":61,"city":75,"state":63,"zip":76,"country":65,"countryCode":66,"cosmosGeoPoint":77,"geoPoint":81,"contacts":28},"The City of Hope Orange County Lennar Foundation Cancer Center","Irvine","92618",{"type":68,"coordinates":78},[79,80],-117.82311,33.66946,{"lat":80,"lon":79},{"facility":83,"status":61,"city":84,"state":63,"zip":85,"country":65,"countryCode":66,"cosmosGeoPoint":86,"geoPoint":90,"contacts":28},"Chao Family Comprehensive Cancer Center","Orange","92868",{"type":68,"coordinates":87},[88,89],-117.85311,33.78779,{"lat":89,"lon":88},{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":65,"countryCode":66,"cosmosGeoPoint":97,"geoPoint":101,"contacts":28},"H. Lee Moffitt Cancer Center","COMPLETED","Tampa","Florida","33612",{"type":68,"coordinates":98},[99,100],-82.45843,27.94752,{"lat":100,"lon":99},{"facility":103,"status":61,"city":104,"state":105,"zip":106,"country":65,"countryCode":66,"cosmosGeoPoint":107,"geoPoint":111,"contacts":28},"Robert H. Lurie Comprehensive Cancer Center of Northwestern University","Chicago","Illinois","60611",{"type":68,"coordinates":108},[109,110],-87.65005,41.85003,{"lat":110,"lon":109},{"facility":113,"status":61,"city":104,"state":105,"zip":114,"country":65,"countryCode":66,"cosmosGeoPoint":115,"geoPoint":117,"contacts":28},"University of Chicago Medical Center","60637",{"type":68,"coordinates":116},[109,110],{"lat":110,"lon":109},{"facility":119,"status":61,"city":120,"state":121,"zip":122,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":127,"contacts":28},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":68,"coordinates":124},[125,126],-71.05977,42.35843,{"lat":126,"lon":125},{"facility":129,"status":61,"city":120,"state":121,"zip":130,"country":65,"countryCode":66,"cosmosGeoPoint":131,"geoPoint":133,"contacts":28},"Dana Farber Cancer Institute Brookline Avenue","02215",{"type":68,"coordinates":132},[125,126],{"lat":126,"lon":125},{"facility":135,"status":61,"city":136,"state":137,"zip":138,"country":65,"countryCode":66,"cosmosGeoPoint":139,"geoPoint":143,"contacts":28},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"type":68,"coordinates":140},[141,142],-83.04575,42.33143,{"lat":142,"lon":141},{"facility":145,"status":61,"city":146,"state":146,"zip":147,"country":65,"countryCode":66,"cosmosGeoPoint":148,"geoPoint":152,"contacts":28},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":68,"coordinates":149},[150,151],-74.00597,40.71427,{"lat":151,"lon":150},{"facility":154,"status":61,"city":155,"state":156,"zip":157,"country":65,"countryCode":66,"cosmosGeoPoint":158,"geoPoint":162,"contacts":28},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":68,"coordinates":159},[160,161],-82.99879,39.96118,{"lat":161,"lon":160},{"facility":164,"status":61,"city":165,"state":166,"zip":167,"country":65,"countryCode":66,"cosmosGeoPoint":168,"geoPoint":172,"contacts":28},"Perelman School of Medicine at the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":68,"coordinates":169},[170,171],-75.16362,39.95238,{"lat":171,"lon":170},{"facility":174,"status":61,"city":175,"state":176,"zip":177,"country":65,"countryCode":66,"cosmosGeoPoint":178,"geoPoint":182,"contacts":28},"Seattle Cancer Care Alliance at South Lake Union - G3630","Seattle","Washington","98109",{"type":68,"coordinates":179},[180,181],-122.33207,47.60621,{"lat":181,"lon":180},{"facility":184,"status":61,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":28},"Universitair Ziekenhuis Leuven","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":68,"coordinates":191},[192,193],4.70093,50.87959,{"lat":193,"lon":192},{"facility":196,"status":61,"city":197,"state":198,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":28},"Hopital Lyon Sud","Pierre-Bénite","Auvergne-Rhône","69310","France","FR",{"type":68,"coordinates":203},[204,205],4.82424,45.70359,{"lat":205,"lon":204},{"facility":208,"status":61,"city":209,"state":210,"zip":211,"country":200,"countryCode":201,"cosmosGeoPoint":212,"geoPoint":216,"contacts":28},"Centre Georges Francois Leclerc","Dijon","Bourgogne-Franche-Comté","21000",{"type":68,"coordinates":213},[214,215],5.01391,47.31344,{"lat":215,"lon":214},{"facility":218,"status":61,"city":219,"state":220,"zip":221,"country":200,"countryCode":201,"cosmosGeoPoint":222,"geoPoint":226,"contacts":28},"Institut Bergonie","Bordeaux","New Aquitaine","33076",{"type":68,"coordinates":223},[224,225],-0.58046,44.84124,{"lat":225,"lon":224},{"facility":228,"status":61,"city":229,"state":230,"zip":231,"country":200,"countryCode":201,"cosmosGeoPoint":232,"geoPoint":236,"contacts":28},"Centre Francois Baclesse (CFB)","Caen","Normandy","14076",{"type":68,"coordinates":233},[234,235],-0.35912,49.18585,{"lat":235,"lon":234},{"facility":238,"status":61,"city":239,"state":28,"zip":240,"country":200,"countryCode":201,"cosmosGeoPoint":241,"geoPoint":245,"contacts":28},"Institut Gustave Roussy","Villejuif","94805",{"type":68,"coordinates":242},[243,244],2.35992,48.7939,{"lat":244,"lon":243},{"facility":247,"status":61,"city":248,"state":249,"zip":250,"country":251,"countryCode":252,"cosmosGeoPoint":253,"geoPoint":257,"contacts":28},"Hospital Clinico Universitario Santiago de Compostela","Santiago de Compostela","A Coruna","15706","Spain","ES",{"type":68,"coordinates":254},[255,256],-8.54569,42.88052,{"lat":256,"lon":255},{"facility":259,"status":61,"city":260,"state":28,"zip":261,"country":251,"countryCode":252,"cosmosGeoPoint":262,"geoPoint":266,"contacts":28},"Institut Catala dOncologia Girona","Girona","17007",{"type":68,"coordinates":263},[264,265],2.82493,41.98311,{"lat":265,"lon":264},{"facility":268,"status":61,"city":269,"state":28,"zip":270,"country":251,"countryCode":252,"cosmosGeoPoint":271,"geoPoint":275,"contacts":28},"Ciudad Universitaria","Madrid","28040",{"type":68,"coordinates":272},[273,274],-3.70256,40.4165,{"lat":274,"lon":273},{"facility":277,"status":61,"city":269,"state":28,"zip":270,"country":251,"countryCode":252,"cosmosGeoPoint":278,"geoPoint":280,"contacts":28},"Hospital Universitario Fundacion Jimenez",{"type":68,"coordinates":279},[273,274],{"lat":274,"lon":273},{"facility":282,"status":61,"city":269,"state":28,"zip":283,"country":251,"countryCode":252,"cosmosGeoPoint":284,"geoPoint":286,"contacts":28},"Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM","28041",{"type":68,"coordinates":285},[273,274],{"lat":274,"lon":273},{"type":288,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100407815","phase-1-a-study-to-find-out-how-safe-regn5668-is-and-how-well-it-works-in-adult-women-when-given-with-either-cemiplimab-or-cemiplimab--fianlimab-or-ubamatamab-100407815",false,"NCT04590326","A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab","A Phase 1\u002F2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol\n2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.\n3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)\n4. Has adequate organ and bone marrow function as defined in the protocol\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has a life expectancy of at least 3 months\n7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy\n2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol\n3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy\n4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy\n5. Has any condition that requires ongoing\u002Fcontinuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug\n6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol\n7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol\n8. Has history of clinically significant cardiovascular disease as defined in the protocol\n9. Has known allergy or hypersensitivity to cemiplimab and\u002For components of study drug(s).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply","FEMALE","18 Years",{"count":299,"type":300},612,"ESTIMATED","INTERVENTIONAL",[303,304],"PHASE1","PHASE2","This study is researching an investigational drug called REGN5668 :\n\n* alone or,\n* combined with cemiplimab (also known as REGN2810) or,\n* combined with both cemiplimab and fianlimab (also known as REGN3767), or\n* combined with ubamatamab (also known as REGN4018), with or without sarilumab.\n\nThe main purposes of this study are to:\n\n* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus\n* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus\n\nThis study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.\n\nThe study is looking at several other research questions, including:\n\n* Side effects that may be experienced by participants taking REGN5668 alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How REGN5668 works in the body either alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood\n* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer",[307,308,309,310],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","Endometrial Cancer",[312,313,314,315],"Progressive","Recurrent","Refractory","Serum CA-125 levels >= 2x ULN","2025-11-20",{"date":318,"type":319},"2025-11-21","ACTUAL",{"date":321,"type":319},"2020-12-08",{"date":323,"type":300},"2027-11-30",{"name":5,"class":6},24]