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Studienlocations (3 von 110)
Goethe University Hospital 60590 Frankfurt/Main (Hessen) GermanyRekrutierend» Google-MapsUniversity Hospital Cologne AöR 50937 Köln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsSRH Wald-Klinikum Gera gGmbH 07548 Gera (Thüringen) GermanyRekrutierend» Google-Maps
Charité - Universitätsmedizin Berlin KöR 10117 Berlin (Berlin) GermanyRekrutierend» Google-MapsCancer and Blood Specialty Clinic 90806 Long Beach United StatesRekrutierend» Google-MapsThe Lundquist Institute - Main 90502-2004 Torrance United StatesRekrutierend» Google-MapsAdventHealth 32804 Orlando United StatesRekrutierend» Google-MapsUniversity of Maryland Medical Center-Greenebaum Cancer Ctr 21201 Baltimore United StatesRekrutierend» Google-MapsSt. Vincent Frontier Cancer Crt 59102-6746 Billings United StatesRekrutierend» Google-MapsClínica Viedma R8500ACE Viedma ArgentinaRekrutierend» Google-MapsFundación CENIT 1125 Caba ArgentinaRekrutierend» Google-MapsCIMMDP 7600 Mar del Plata ArgentinaRekrutierend» Google-MapsInstituto de Oncologia de Rosario 2000 Rosario ArgentinaRekrutierend» Google-MapsISIS Clinica Especializada S3000FFU Santa Fe ArgentinaRekrutierend» Google-MapsUniversity Clinical Centre of the Republic of Srpska - Gastroenterology 78000 Banjaluka Bosnia and HerzegovinaRekrutierend» Google-MapsUniversity Clinical Hospital Mostar 88000 Mostar Bosnia and HerzegovinaRekrutierend» Google-MapsClinical Center University of Sarajevo 71000 Sarajevo Bosnia and HerzegovinaRekrutierend» Google-MapsUniversity Clinical Center Tuzla 75000 Tuzla Bosnia and HerzegovinaRekrutierend» Google-MapsCantonal hospital Zenica 72000 Zenica Bosnia and HerzegovinaRekrutierend» Google-MapsHospital Sao Rafael Salvador BrazilRekrutierend» Google-MapsCentro de Oncologia Leonardo da Vinci -ATO Oncologia 60140-025 Fortaleza BrazilRekrutierend» Google-MapsHospital Sirio Libanes - Brasilia 70200 730 Brasilia BrazilRekrutierend» Google-MapsCentro de Tratamento Oncologico 66063-495 Belém BrazilRekrutierend» Google-MapsPUCRS - Hospital São Lucas 90610-000 Porto Alegre BrazilRekrutierend» Google-MapsCEPON-Centro de Pesquisas Oncológicas 888034-000 Florianopolis BrazilRekrutierend» Google-MapsHospital de Cancer de Barretos 14784 400 Barretos BrazilRekrutierend» Google-MapsHospital e Maternidade Brasil CEP 04501-000 Sao Paulo BrazilRekrutierend» Google-MapsFac Med de Sao Jose do Rio Preto 15090-000 São José do Rio Preto BrazilRekrutierend» Google-MapsInstituto de Oncologia do Parana Curitiba BrazilRekrutierend» Google-MapsInstituto Nacional de Câncer - INCA 20231-050 Rio de Janeiro BrazilRekrutierend» Google-MapsCentro de Estudios Clínicos SAGA SpA 7500653 Santiago ChileRekrutierend» Google-MapsOncocentro APYS 2520612 Viña Del Mar ChileRekrutierend» Google-MapsUniversity Hospital Centre Zagreb 10 000 Zagreb CroatiaRekrutierend» Google-MapsKBC "Sestre milosrdnice" 10000 Zagreb CroatiaRekrutierend» Google-MapsHôpital F Mitterrand - Dermatology 21000 Dijon FranceRekrutierend» Google-MapsCHU de Bordeaux - Hopital Saint André 33000 Bordeaux FranceRekrutierend» Google-MapsCHU de Poitiers 21079 Poitiers FranceRekrutierend» Google-MapsHopital Ambroise Paré - Dermatologie 92104 Boulogne Billancourt cedex FranceRekrutierend» Google-MapsISR-GEO Med Res Clin Healthycore 0112 Tbilisi GeorgiaRekrutierend» Google-MapsLLC "Todua Clinic" 0112 Tbilisi GeorgiaRekrutierend» Google-MapsJSC KE Nat Ctr of Exp and Clin Surg 0159 Tbilisi GeorgiaRekrutierend» Google-MapsIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L 47014 Meldola ItalyRekrutierend» Google-MapsIstituto dei Tumori "Giovanni Paolo II" 70124 Bari ItalyRekrutierend» Google-MapsASST Papa Giovanni XXIII 24127 Bergamo ItalyRekrutierend» Google-MapsOspedale San Raffaele, IRCCS 20132 Milano ItalyRekrutierend» Google-MapsIstituto Europeo di Oncologia IRCCS 20141 Milano ItalyRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Federico II 80131 Napoli ItalyRekrutierend» Google-MapsFondazione IRCCS Policlinico San Matteo 27100 Pavia ItalyRekrutierend» Google-MapsIstituto Dermopatico dell'Immacolata (IDI) - IRCCS 00167 Roma ItalyRekrutierend» Google-MapsAzienda ospedaliero Universitaria Senese - Policlinico Le Scotte 53100 Siena ItalyRekrutierend» Google-MapsASST Sette Laghi - Ospedale di Circolo Fondazione Macchi 21100 Varese ItalyRekrutierend» Google-MapsNagoya City University Hospital - Dermatology 467-8601 Nagoya JapanRekrutierend» Google-MapsSapporo Medical University Hospital 060-8543 Sapporo-Shi JapanRekrutierend» Google-MapsNHO Kagoshima Medical Center 892-0853 Kagoshima-Shi JapanRekrutierend» Google-MapsShizuoka Cancer Center - Dermatology 135-8550 Koto-Ku JapanRekrutierend» Google-MapsKeio University Hospital - Dermatology 160-8582 Shinjuku-ku JapanRekrutierend» Google-MapsKumamoto University Hospital - Dermatology 860-8556 Kumamoto JapanRekrutierend» Google-MapsNiigata Cancer Center Hospital 951-8566 Niigata JapanRekrutierend» Google-MapsOsaka International Cancer Institute - Dermatological Oncology 541-8567 Osaka-shi JapanRekrutierend» Google-MapsInje University Haeundae Paik Hospital 48108 Busan Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsHospital Universiti Sains Malaysia 16150 Kubang Kerian MalaysiaRekrutierend» Google-MapsHospital Pulau Pinang Pulau Pinang MalaysiaRekrutierend» Google-MapsHospital Umum Sarawak Kuching MalaysiaRekrutierend» Google-MapsInstitut Kanser Negara 62250 Putrajaya MalaysiaRekrutierend» Google-MapsHospital Canselor Tuanku Muhriz UKM 56000 Kuala Lumpur MalaysiaRekrutierend» Google-MapsHospital Kuala Lumpur Kuala Lumpur MalaysiaRekrutierend» Google-MapsCentro Inmuno Oncolog de Occidente 44630 Guadalajara MexicoRekrutierend» Google-MapsI CAN ONCOLOGY CENTER SA de CV 64710 Monterrey MexicoRekrutierend» Google-MapsCtro At Inv Cardio Potosi 78200 San Luis Potosi MexicoRekrutierend» Google-MapsCentro De Atenc E Inv Clín En Onco 97134 Merida MexicoRekrutierend» Google-MapsCentro de Inv Medica Aguascalientes 20115 Aguascalientes MexicoRekrutierend» Google-MapsOncare Viaducto Napoles 14080 Mexico City MexicoRekrutierend» Google-MapsClinica Integral Internac Oncologia 72530 Puebla MexicoRekrutierend» Google-MapsAlthian Research Management Center 66278 San Pedro Garza Garcia MexicoRekrutierend» Google-MapsCentro Medico Zambrano Hellion 66278 San Pedro Garza García MexicoRekrutierend» Google-MapsClinical Research Institute S.C. Tlalnepantla de Baz MexicoRekrutierend» Google-MapsAmphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht 4818 CK Breda NetherlandsRekrutierend» Google-MapsArensia - Iocn 400015 Cluj-Napoca RomaniaRekrutierend» Google-MapsArensia - Iob 022328 Bucuresti RomaniaRekrutierend» Google-MapsVojvodina Institute for Oncology 21204 Sremska Kamenica SerbiaRekrutierend» Google-MapsMilitary Medical Academy 11000 Belgrade SerbiaRekrutierend» Google-MapsSpecialized hospital Oncomed System 11070 Belgrade SerbiaRekrutierend» Google-MapsInstitute for Oncology and Radiology of Serbia Beograd SerbiaRekrutierend» Google-MapsUniversity Clinical Center Kragujevac 34000 Kragujevac SerbiaRekrutierend» Google-MapsUniversity Clinical Center Nis 18108 Nis SerbiaRekrutierend» Google-MapsMedical Oncology Cent of Rosebank 2196 Johannesburg South AfricaRekrutierend» Google-MapsWits Clinical Research 2193 Parktown, Johannesburg South AfricaRekrutierend» Google-MapsMary Potter Oncology Centre 0181 Pretoria South AfricaRekrutierend» Google-MapsRondebosch Oncology Centre 7700 Cape Town South AfricaRekrutierend» Google-MapsCape Town Oncology Trials 7570 Kraaifontein South AfricaRekrutierend» Google-MapsHospital Universitario Virgen De La Macarena 41009 Sevilla SpainRekrutierend» Google-MapsInstitut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol 08916 Badalona SpainRekrutierend» Google-MapsHospital San Pedro de Alcántara 10003 Caceres SpainRekrutierend» Google-MapsM.D. Anderson Center Madrid 28033 Madrid, SpainRekrutierend» Google-MapsH.U.V.Arrixaca 30120 El Palmar SpainRekrutierend» Google-MapsHospital de La Santa Creu i Sant Pau 08025 Barcelona SpainRekrutierend» Google-MapsHospital Universitari Vall D Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHospital Clinic De Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsHospital Jerez Puerta Del Sur 41009 Sevilla SpainRekrutierend» Google-MapsConsorcio Hospital General Universitario de Valencia 46014 Valencia SpainRekrutierend» Google-MapsChina Medical University Hospital - Internal Medicine 40447 Taichung TaiwanRekrutierend» Google-MapsTaipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare 23561 New Taipei City TaiwanRekrutierend» Google-MapsTaipei Municipal Wanfang Hospital - Managed by Taipei Medical University 11696 Taipei TaiwanRekrutierend» Google-MapsKhon Kaen University, Srinagarind Hospital 40002 Khonkaen ThailandRekrutierend» Google-MapsKing Chulalongkorn Memorial Hospital [Medical Oncology] 10330 Bangkok ThailandRekrutierend» Google-MapsSiriraj Hospital 10700 Bangkok ThailandRekrutierend» Google-MapsPrince of Songkla University - Faculty of Medicine 90110 Songkhla ThailandRekrutierend» Google-Maps
1. Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) (Time Frame - Day 1 (Postdose) through Day 28): The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
2. Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS) (Time Frame - Week 17 through Week 21): The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Secondary outcome:
1. Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) (Time Frame - Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)): The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
2. Maximum Observed Serum Concentration at Steady State (Cmax_ss) (Time Frame - Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)): The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
3. Serum Concentrations at Predose (Ctrough) (Time Frame - Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)): The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.
4. Number of Subjects With Treatment-Emergent Serious Adverse Events (Time Frame - Week 1 (First dose of study drug) through Week 53 (End of Study)): The safety (treatment-emergent serious adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
5. Number of Subjects With Treatment-Emergent Adverse Events (Time Frame - Week 1 (First dose of study drug) through Week 53 (End of Study)): The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
6. Number of Subjects With Treatment-emergent Adverse Events-of-interest (Time Frame - Week 1 (First dose of study drug) through Week 53 (End of Study)): The safety (treatment-emergent adverse events-of-interest) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in adjuvant setting.
7. Number of Subjects With Anti-drug Antibodies (ADAs) (Time Frame - Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)): The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
8. Recurrence-free Survival (RFS) (Time Frame - Randomization through 12 months (or until RFS criteria is met)): The RFS is assessed to compare the efficacy of ABP 206 with nivolumab in subjects with advanced melanoma in the adjuvant setting. The RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional, distant metastasis) or death (whatever the cause), or date of last visit/contact with disease assessments (for subjects who remain alive and whose disease has not recurred).
9. Time to reach Cmax following the first dose (Tmax_dose 1) (Time Frame - Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)): The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
10. Time to reach Cmax at steady state (Tmax_ss) (Time Frame - Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)): The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
11. Serum Concentrations (Ctrough) (Time Frame - At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)): The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
