[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575239":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":267,"collaborators":39,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":39,"eligibilityCriteria":275,"healthyVolunteers":271,"sex":276,"minAge":277,"maxAge":39,"enrollmentInfo":278,"targetDuration":39,"studyType":281,"phases":282,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":53,"whyStopped":39,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo.",[13,14,15],"Drug: FDC fianlimab+cemiplimab","Drug: Cemiplimab","Drug: Placebo",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort 2","Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1.",[13,14,15],[21,30,36],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","FDC fianlimab+cemiplimab","Fixed-Dose Combination (FDC) Administered per the protocol",[9,17],[27,28,29],"REGN3767","REGN2810","Libtayo",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cemiplimab","Administered per the protocol",[9,17],[35,29],"R2810",{"type":22,"name":37,"description":32,"armGroupLabels":38,"otherNames":39},"Placebo",[9,17],null,[41],{"name":42,"affiliation":5,"role":43},"Clinical Trial Management","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":39,"email":49},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[51,65,75,85,95,104,114,124,134,144,154,163,173,183,195,207,217,227,239,249,258],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":39},"University of California Los Angeles","RECRUITING","Los Angeles","California","90024","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-118.24368,34.05223,{"lat":63,"lon":62},{"facility":66,"status":53,"city":67,"state":68,"zip":69,"country":57,"countryCode":58,"cosmosGeoPoint":70,"geoPoint":74,"contacts":39},"Orlando Health","Orlando","Florida","32806",{"type":60,"coordinates":71},[72,73],-81.37924,28.53834,{"lat":73,"lon":72},{"facility":76,"status":53,"city":77,"state":78,"zip":79,"country":57,"countryCode":58,"cosmosGeoPoint":80,"geoPoint":84,"contacts":39},"Emory University School of Medicine","Atlanta","Georgia","30308",{"type":60,"coordinates":81},[82,83],-84.38798,33.749,{"lat":83,"lon":82},{"facility":86,"status":53,"city":87,"state":88,"zip":89,"country":57,"countryCode":58,"cosmosGeoPoint":90,"geoPoint":94,"contacts":39},"St. Elizabeth Healthcare","Edgewood","Kentucky","41017",{"type":60,"coordinates":91},[92,93],-84.58189,39.01867,{"lat":93,"lon":92},{"facility":96,"status":53,"city":97,"state":88,"zip":98,"country":57,"countryCode":58,"cosmosGeoPoint":99,"geoPoint":103,"contacts":39},"Norton Cancer Institute","Louisville","40202",{"type":60,"coordinates":100},[101,102],-85.75941,38.25424,{"lat":102,"lon":101},{"facility":105,"status":53,"city":106,"state":107,"zip":108,"country":57,"countryCode":58,"cosmosGeoPoint":109,"geoPoint":113,"contacts":39},"Henry Ford Cancer Institute\u002FHenry Ford Health System","Detroit","Michigan","48202",{"type":60,"coordinates":110},[111,112],-83.04575,42.33143,{"lat":112,"lon":111},{"facility":115,"status":53,"city":116,"state":117,"zip":118,"country":57,"countryCode":58,"cosmosGeoPoint":119,"geoPoint":123,"contacts":39},"Oncology Hematology West P.C. dba Nebraska Cancer Specialists","Omaha","Nebraska","68130",{"type":60,"coordinates":120},[121,122],-95.94043,41.25626,{"lat":122,"lon":121},{"facility":125,"status":53,"city":126,"state":127,"zip":128,"country":57,"countryCode":58,"cosmosGeoPoint":129,"geoPoint":133,"contacts":39},"Ohio State University","Columbus","Ohio","43210",{"type":60,"coordinates":130},[131,132],-82.99879,39.96118,{"lat":132,"lon":131},{"facility":135,"status":53,"city":136,"state":137,"zip":138,"country":57,"countryCode":58,"cosmosGeoPoint":139,"geoPoint":143,"contacts":39},"Asplundh Cancer Pavilion","Willow Grove","Pennsylvania","19090",{"type":60,"coordinates":140},[141,142],-75.11573,40.144,{"lat":142,"lon":141},{"facility":145,"status":53,"city":146,"state":147,"zip":148,"country":57,"countryCode":58,"cosmosGeoPoint":149,"geoPoint":153,"contacts":39},"University of Tennessee Medical Center","Knoxville","Tennessee","37920",{"type":60,"coordinates":150},[151,152],-83.92074,35.96064,{"lat":152,"lon":151},{"facility":155,"status":53,"city":156,"state":147,"zip":157,"country":57,"countryCode":58,"cosmosGeoPoint":158,"geoPoint":162,"contacts":39},"Vanderbilt-Ingram Cancer Center","Nashville","37232",{"type":60,"coordinates":159},[160,161],-86.78444,36.16589,{"lat":161,"lon":160},{"facility":164,"status":53,"city":165,"state":166,"zip":167,"country":57,"countryCode":58,"cosmosGeoPoint":168,"geoPoint":172,"contacts":39},"Joe Arrington Cancer Research & Treatment Center","Lubbock","Texas","79410",{"type":60,"coordinates":169},[170,171],-101.85517,33.57786,{"lat":171,"lon":170},{"facility":174,"status":53,"city":175,"state":176,"zip":177,"country":57,"countryCode":58,"cosmosGeoPoint":178,"geoPoint":182,"contacts":39},"Inova Schar Cancer Institute","Fairfax","Virginia","22031",{"type":60,"coordinates":179},[180,181],-77.30637,38.84622,{"lat":181,"lon":180},{"facility":184,"status":53,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":39},"Peter MacCallum Cancer Centre (PMCC)","Melbourne","Victoria","3050","Australia","AU",{"type":60,"coordinates":191},[192,193],144.96332,-37.814,{"lat":193,"lon":192},{"facility":196,"status":53,"city":197,"state":198,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":39},"Centre Jean Perrin","Clermont-Ferrand","Auvergne-Rhône","63011","France","FR",{"type":60,"coordinates":203},[204,205],3.08682,45.77969,{"lat":205,"lon":204},{"facility":208,"status":53,"city":209,"state":210,"zip":211,"country":200,"countryCode":201,"cosmosGeoPoint":212,"geoPoint":216,"contacts":39},"Timone Hospital - AP-HM","Marseille","Bordeaux","13005",{"type":60,"coordinates":213},[214,215],5.38107,43.29695,{"lat":215,"lon":214},{"facility":218,"status":53,"city":219,"state":220,"zip":221,"country":200,"countryCode":201,"cosmosGeoPoint":222,"geoPoint":226,"contacts":39},"Hopital Europeen Geroges Pompidou AP-HP","Paris","Île-de-France Region","75015",{"type":60,"coordinates":223},[224,225],2.3488,48.85341,{"lat":225,"lon":224},{"facility":228,"status":53,"city":229,"state":230,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":39},"Hospital Universitario Virgen del Rocio","Seville","Andalusia","41013","Spain","ES",{"type":60,"coordinates":235},[236,237],-5.97317,37.38283,{"lat":237,"lon":236},{"facility":240,"status":53,"city":241,"state":242,"zip":243,"country":232,"countryCode":233,"cosmosGeoPoint":244,"geoPoint":248,"contacts":39},"Hospital Clinic","Barcelona","Catalonia","08036",{"type":60,"coordinates":245},[246,247],2.15899,41.38879,{"lat":247,"lon":246},{"facility":250,"status":53,"city":251,"state":39,"zip":252,"country":232,"countryCode":233,"cosmosGeoPoint":253,"geoPoint":257,"contacts":39},"Centro Oncologico de Galicia","A Coruña","15009",{"type":60,"coordinates":254},[255,256],-8.396,43.37135,{"lat":256,"lon":255},{"facility":259,"status":53,"city":260,"state":39,"zip":261,"country":232,"countryCode":233,"cosmosGeoPoint":262,"geoPoint":266,"contacts":39},"Hospital Universitario La Paz","Madrid","28046",{"type":60,"coordinates":263},[264,265],-3.70256,40.4165,{"lat":265,"lon":264},{"type":268,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100575239","phase-2-a-study-to-see-if-giving-fianlimab-and-cemiplimab-together-is-better-than-cemiplimab-alone-at-treating-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100575239",false,"NCT06769698","A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression","Key Inclusion Criteria:\n\n1. Have histologically confirmed (by local pathology) R\u002FM HNSCC that is considered incurable by local therapies\n2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol\n3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol\n4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol\n5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions\n\n1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol\n2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)\n3. Head and neck SCC with unknown primary site as described in the protocol\n4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol\n5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management\n6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.\n\n   Prior\u002FConcomitant Therapy\n7. Participants who have received prior systemic anticancer therapy in the R\u002FM HNSCC setting as described in the protocol\n8. Participants with a condition requiring corticosteroid therapy (\\>10 mg prednisone\u002Fprednisolone\u002Fday or equivalent) within 14 days of the first dose of study drug as described in the protocol\n\nNote: Other protocol defined Inclusion\u002F Exclusion Criteria apply","ALL","18 Years",{"count":279,"type":280},120,"ESTIMATED","INTERVENTIONAL",[283],"PHASE2","This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called \"study drugs\" in this form.\n\nThe study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC).\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much of each study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)\n* Compatible research to better understand the study drugs and HNSCC",[286],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[288,289,290],"Recurrent or Metastatic (R\u002FM)","Positive for Programmed Death Ligand 1 (PD-L1) Expression","Human Papillomavirus (HPV)","2026-06-24",{"date":293,"type":294},"2026-06-25","ACTUAL",{"date":296,"type":294},"2026-04-14",{"date":298,"type":280},"2030-12-28",{"name":5,"class":6},21]