NCT Dermatoonkologie -Hautklinik Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR 55131 Mainz (Rheinland-Pfalz) GermanyRekrutierend» Google-MapsCharite- Universitaetsmedizin Berlin 10117 Berlin (Berlin) GermanyRekrutierend» Google-Maps
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital 44791 Bochum (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsElbekliniken Buxtehude 21614 Buxtehude (Niedersachsen) GermanyRekrutierend» Google-MapsUniversity Hospital Dresden 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Essen (AoR) 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsSLK-Kliniken Heilbronn GmbH 74078 Heilbronn (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Schleswig-Holstein, Campus Kiel 24105 Kiel (Schleswig-Holstein) GermanyRekrutierend» Google-MapsKlinikum der Universitaet zu Koeln 50937 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsLMU Munchen 80337 Muenchen (Bayern) GermanyRekrutierend» Google-MapsUniversity Hospital Tuebingen 72076 Tuebingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsBanner MD Anderson Cancer Center 85234 Gilbert United StatesRekrutierend» Google-MapsMayo Clinic Hospital 85054 Phoenix United StatesRekrutierend» Google-MapsRegeneron Study Site 85724-5024 Tucson United StatesAbgeschlossen» Google-MapsThe Angeles Clinic 90025 Los Angeles United StatesAbgeschlossen» Google-MapsUniversity of Southern California (USC) 90033 Los Angeles United StatesRekrutierend» Google-MapsStanford Cancer Institute, Stanford Medicine at Stanford University 94304 Palo Alto United StatesRekrutierend» Google-MapsUniversity Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center 94143-0981 San Francisco United StatesAbgeschlossen» Google-MapsGeorge Washington University School of Medicine and Health Sciences 20037 Washington United StatesRekrutierend» Google-MapsUniversity of Florida Health 032608 Gainesville United StatesAbgeschlossen» Google-MapsSylvester Comprehensive Cancer Center 33136 Miami United StatesAbgeschlossen» Google-MapsMiami Cancer Institute at Baptist Health, Inc. 33176 Miami United StatesRekrutierend» Google-MapsUniversity of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute 33612 Tampa United StatesRekrutierend» Google-MapsRegeneron Study Site 30342 Atlanta United StatesAbgeschlossen» Google-MapsRegeneron Study Site 60611 Chicago United StatesAbgeschlossen» Google-MapsRegeneron Study Site 40202 Louisville United StatesAbgeschlossen» Google-MapsRegeneron Study Site 21287 Baltimore United StatesAbgeschlossen» Google-MapsMassachusetts General Cancer Center 02114 Boston United StatesRekrutierend» Google-MapsDana Farber/Harvard Cancer Center 02215 Boston United StatesRekrutierend» Google-MapsMichigan Medicine- University of Michigan 48109 Ann Arbor United StatesRekrutierend» Google-MapsUniversity of Missouri Health Care - University Physicians - Medicine Specialty Clinic 65212 Columbia United StatesRekrutierend» Google-MapsWashington University in Saint Louis 63110 Saint Louis United StatesRekrutierend» Google-MapsNebraska Methodist Hospital 68114 Omaha United StatesRekrutierend» Google-MapsMemorial Sloan Kettering 07920 Basking Ridge United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 07748 Middletown United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 07645 Montvale United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 08903 New Brunswick United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 11725 Commack United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 10604 Harrison United StatesAktiv, nicht rekrutierend» Google-MapsNYU Langone Health 10016 New York United StatesAbgeschlossen» Google-MapsColumbia University 10032 New York United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 10065 New York United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering 11553 Uniondale United StatesAktiv, nicht rekrutierend» Google-MapsRegeneron Research Site 45267 Cincinnati United StatesAbgeschlossen» Google-MapsThe Ohio State University 43230 Gahanna United StatesRekrutierend» Google-MapsPenn State Hershey Children's Hospital 17025 Hershey United StatesRekrutierend» Google-MapsUniversity of Pennsylvania 19104 Philadelphia United StatesRekrutierend» Google-MapsSarah Cannon Research Institute - Tennessee Oncology 37203 Nashville United StatesRekrutierend» Google-MapsTexas Oncology - Baylor Charles A. Simmons Cancer Center 75246 Dallas United StatesAbgeschlossen» Google-MapsUT Southwestern Medical Center 75390 Dallas United StatesRekrutierend» Google-MapsUniversity Of Virginia Health System 22908 Charlottesville United StatesRekrutierend» Google-MapsThe Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre 2640 Albury AustraliaRekrutierend» Google-MapsCoffs Harbour Health Campus 2450 Coffs Harbour AustraliaAktiv, nicht rekrutierend» Google-MapsCentral Coast Cancer Centre-Gosford and Wyong Hospitals 2250 Gosford AustraliaRekrutierend» Google-MapsSt George Hospital 2217 Kogarah AustraliaRekrutierend» Google-MapsNorth Shore Private Hospital 2065 St Leonards AustraliaRekrutierend» Google-MapsCancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC) 2650 Wagga Wagga AustraliaRekrutierend» Google-MapsCalvary Mater Newcastle 2298 Waratah AustraliaRekrutierend» Google-MapsWestmead Hospital 2145 Westmead AustraliaRekrutierend» Google-MapsIllawarra Cancer Care Centre (ICCC) 2500 Wollongong AustraliaRekrutierend» Google-MapsMelanoma Institute 2060 Sydney AustraliaRekrutierend» Google-MapsWide Bay Hospital and Health Service - Cancer Care Services 4670 Bundaberg AustraliaRekrutierend» Google-MapsCairns Hospital 4870 Cairns AustraliaRekrutierend» Google-MapsThe Royal Brisbane and Women's Hospital 4029 Herston AustraliaRekrutierend» Google-MapsICON Cancer Care 4215 Southport AustraliaRekrutierend» Google-MapsToowoomba Hospital 4350 Toowoomba AustraliaRekrutierend» Google-MapsGenesis Care Tugun - John Flynn Private Hospital 4224 Tugun AustraliaRekrutierend» Google-MapsWide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay 4655 Urraween AustraliaRekrutierend» Google-MapsPrincess Alexandra Hospital 4102 Woolloongabba AustraliaRekrutierend» Google-MapsAshford Cancer Centre Research-Adelaide Cancer Centre 5037 Kurralta Park AustraliaRekrutierend» Google-MapsRoyal Hobart Hospital-Hobart Hospital 7000 Hobart AustraliaRekrutierend» Google-MapsRoyal Hobart Hospital 7000 Hobart AustraliaRekrutierend» Google-MapsBendigo Health 3550 Bendigo AustraliaRekrutierend» Google-MapsSt. Vincent's Hospital 3065 Fitzroy AustraliaRekrutierend» Google-MapsOlivia Newton -John Cancer Wellness & Research Centre 3084 Heidelberg AustraliaRekrutierend» Google-MapsPeter Maccallum Cancer Centre (PMCC) 3000 Melbourne AustraliaRekrutierend» Google-MapsSir Charles Gairdner Hospital 6009 Nedlands AustraliaRekrutierend» Google-MapsRoyal Adelaide Hospital 5000 Adelaide AustraliaRekrutierend» Google-MapsLiverpool Cancer Therapy Center 2170 Liverpool AustraliaRekrutierend» Google-MapsUniversity of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre 2170 Liverpool AustraliaRekrutierend» Google-MapsThe Townsville Hospital and Health Service 4814 Townsville AustraliaRekrutierend» Google-MapsUniversitair Ziekenhuis Leuven Gasthuisberg Campus 3000 Leuven BelgiumRekrutierend» Google-MapsCliniques Universitaires Saint-Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsFundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I 35160-158 Ipatinga BrazilRekrutierend» Google-MapsFundacao Pio XII - Hospital de Cancer de Barretos 90610-000 Barretos BrazilRekrutierend» Google-MapsInstituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA 20220-410 Santo Cristo BrazilRekrutierend» Google-MapsHospital Sao Vicente de Paulo (HSVP) 99010-080 Passo Fundo BrazilRekrutierend» Google-MapsCentro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS 90610-000 Porto Alegre BrazilRekrutierend» Google-MapsCentro De Novos Tratamentos Itajai 88301-220 Itajai BrazilRekrutierend» Google-MapsANIMI 88501-001 Lajes BrazilRekrutierend» Google-MapsCentro Oncologico Mogi das Cruzes 08730-500 Mogi das Cruzes BrazilRekrutierend» Google-MapsHospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP 14049-900 Ribeirao Preto BrazilRekrutierend» Google-MapsYnova pesquisa clinica 88020-210 Florianopolis BrazilRekrutierend» Google-MapsInstituto do Cancer do Estado de Sao Paulo - ICESP 05403-000 Sao Paulo BrazilRekrutierend» Google-MapsUniversity Health Network- Princess Margaret Cancer Center M5G 2M9 Toronto CanadaRekrutierend» Google-MapsCentre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage 21079 Dijon FranceRekrutierend» Google-MapsHopital Saint Andre - CHU de Bordeaux 33604 Bordeaux FranceRekrutierend» Google-MapsHopital Ambroise Pare 92100 Boulogne Billancourt FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon 38700 La Tronche FranceRekrutierend» Google-MapsCentre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez 59037 Lille FranceRekrutierend» Google-MapsCentre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) 69008 Lyon FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu 44093 Nantes FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nice,Hopital l Archet 06202 Nice FranceRekrutierend» Google-MapsHospital Saint-Louis - 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Dermatologia - University of Bologna 40138 Bologna ItalyRekrutierend» Google-MapsASST Spedali Civili Brescia 089263 Brescia ItalyRekrutierend» Google-MapsUniversity of Brescia 25121 Brescia ItalyRekrutierend» Google-MapsUniversita di Firenze - Azienda Sanitaria Firenze 50125 Firenze ItalyRekrutierend» Google-MapsUniversity L'Aquila 67100 L'Aquila ItalyRekrutierend» Google-MapsIRCCS-Istituto Europeo di Oncologia 20141 Milan ItalyRekrutierend» Google-MapsU.O.S.C Di Oncologia Medica E Terapie Innovative 43100 Napoli ItalyRekrutierend» Google-MapsA. Gemelli University Hospital, Catholic University of the Sacred Heart 00168 Rome ItalyRekrutierend» Google-MapsIRCCS Istituto Clinico Humanitas 20089 Rozzano ItalyRekrutierend» Google-MapsAOU Citta della Salute e della Scienza di Torino 10126 Torino ItalyRekrutierend» Google-MapsSapporo Medical University Hospital 060-8543 Sapporo JapanRekrutierend» Google-MapsShizuoka Cancer Center - Oncology 411-8777 Nagaizumi-Cho JapanRekrutierend» Google-MapsNational Cancer Center Hospital - Gastrointestinal Oncology 104-0045 Chuo-ku JapanRekrutierend» Google-MapsNiigata Cancer Center Hospital 951-8566 Niigata JapanRekrutierend» Google-MapsOsaka International Cancer Institute - Clinical Oncology 541-8567 Osaka JapanRekrutierend» Google-MapsRegeneron Study Site 1023 Auckland New ZealandAbgeschlossen» Google-MapsPalmerston North Hospital 4410 Palmerston North New ZealandRekrutierend» Google-MapsNarodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach 44-102 Gliwice PolandRekrutierend» Google-MapsRegeneron Study Site 30-820 Krakow PolandAbgeschlossen» Google-MapsRegeneron Study Site 61-306 Poznan PolandAbgeschlossen» Google-MapsRegeneron Study Site 04-141 Warsaw PolandAbgeschlossen» Google-MapsNarodowy Instytut Onkologii im. 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1. DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. (Time Frame - Up to 54 months): For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
Secondary outcome:
1. Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive. (Time Frame - Up to 78 months)
2. FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death. (Time Frame - Up to 54 months): For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
3. Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death. (Time Frame - Up to 54 months): For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
4. Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study. (Time Frame - Up to 54 months)
5. Incidence and severity of treatment-emergent adverse events (TEAE) (Time Frame - Up to 78 months)
6. Incidence of deaths (Time Frame - Up to 78 months)
7. Incidence of laboratory abnormalities (Time Frame - Up to 78 months)
8. Cemiplimab concentrations in serum (Time Frame - Up to 78 months)
9. Anti-drug antibodies (ADA) in serum (Time Frame - Up to 78 months)