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A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Sponsor: Amgen
Summary
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
Official title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
633
Start Date
2023-11-02
Completion Date
2028-01-25
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
ABP 206
ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
Locations (180)
Cancer and Blood Specialty clinic
Long Beach, California, United States
Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
Fort Wayne, Indiana, United States
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
Baton Rouge, Louisiana, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP
East Syracuse, New York, United States
Centro de Investigaciones Médicas y Desarrollo LC
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
Mar Del Plata, Río Negro Province, Argentina
Clínica Viedma - Oncology
Viedma, Río Negro Province, Argentina
Instituto De Oncologia De Rosario
Rosario, Santa Fe Province, Argentina
ISIS Clinica Especializada
Santa Fe, Argentina
Clinical Center University of Sarajevo - Clinic of Oncology
Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
University Clinical Center of Republic of Srpska
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla - Oncology, Hematology and Radio
Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina
Cantonal hospital Zenica - Oncology
Zenica, Zeničko-dobojski Kanton, Bosnia and Herzegovina
Dr. Everett Chalmers Hospital - Oncology
Fredericton, New Brunswick, Canada
IC La Serena Research
La Serena, Coquimbo Region, Chile
Centro de Investigacion y Desarrollo Oncologico
Temuco, Región de la Araucanía, Chile
Oncocentro Apys
Valparaíso, Región de Valparaíso, Chile
Icegclinic Research & Care
Estacion Central, Santiago Metropolitan, Chile
University Hospital Centre Zagreb - Oncology department
Zagreb, City of Zagreb, Croatia
Poliklinika Anova
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Osijek
Osijek, Osjecko-baranjska Županija, Croatia
FN Hradec Kralove - Klinika onkologie a radioterap
Hradec Kralove, Moravskoslezský kraj, Czechia
Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka
Prague, Czechia
Tartu University Hospital - Oncology
Tartu, Tartu, Estonia
CHU de Poitiers
Poitier, Haute-Vienne, France
Centre Hospitalier De Saint Malo - Oncologie
Rennes, Ille-et-Vilaine, France
C.H.R.U Hopital Claude Huriez - Dermatologie
Lille, Nord, France
LTD "High technology hospital MEDCENTER"
Batumi, Adjara, Georgia
LLC "Todua Clinic"
Tbilisi, Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, Georgia
LTD "Multprofile Clinic Consilium Medulla" - Oncology
Tbilisi, Georgia
Goethe University Frankfurt
Frankfurt am Main, Hesse, Germany
Philipps-University Marburg
Marburg, Hesse, Germany
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico
Crema, Cremona, Italy
IRST Dino Amadori (IRST IRCCS) - UNK
Meldola, Forli, Italy
PO Ospedale San Vincenzo - Oncologia Medica
Taormina, Messina, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
AO Ss Antonio, Biagio e Arrigo
Alessandria, Italy
AUO Consorziale-Policlinico Bari
Bari, Italy
Istituto dei Tumori Giovanni Paolo II - Oncologia Medica - Tumori Rari e Melanoma
Bari, Italy
ASST Papa Giovanni XXIII - Oncologia
Bergamo, Italy
AOU Careggi
Florence, Italy
IRCCS Ca'Granda Maggiore Policlinic
Milan, Italy
Ospedale San Raffaele, IRCCS - Oncologia Medica
Milan, Italy
AOU Luigi Vanvitelli
Naples, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare
Naples, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica
Roma, Italy
IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
Roma, Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
Roma, Italy
Ospedale Isola Tiberina - Gemelli Isola - Oncologia Medica
Roma, Italy
AOU Senese, Policlinico Le Scotte
Siena, Italy
Ospedale di Circolo, Presidio di Varese - Oncologia
Varese, Italy
Al Khalidi Hospital and Medical Center - Research
Amman, 'Ammān, Jordan
The Speciality Hospital (TSH) / Advanced Clinical Center
Amman, 'Ammān, Jordan
King Hussein Cancer Center
Amman, Jordan
Pharmaceutical Research Center (KAUH)
Irbid, Jordan
Saint George Hospital University Medical Center
El Achrafiyé, Beyrouth, Lebanon
Nini Hospital
Tripoli, Loubnâne Ech Chemâli, Lebanon
Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology
Saida, Loubnâne Ej Jnoûbi, Lebanon
Ain Wazein Hospital - internal medicine
Beirut, Lebanon
American University of Beirut Medical Center - Haematology
Beirut, Lebanon
Hotel Dieu de France Hospital - Oncology
Beirut, Lebanon
National Cancer Institute - Conservative Tumour Therapy
Vilnius, Vilnius County, Lithuania
Hospital Pulau Pinang
Pulau Pinang, Pahang, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
National Cancer Institute - Radiotherapy and Oncology
Putrajaya, Selangor, Malaysia
HOSPITAL UNIVERSITI SAINS MALAYSIA - Pediatrics
Kubang Kerian, Terengganu, Malaysia
Hospital Kuala Lumpur - Surgery
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Pantai Hospital Kuala Lumpur - Oncology
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Preparaciones Oncologica SC
León, Guanajuato, Mexico
Centro de Inm Onc de Occ Sa de Cv
Guadalajra, Jalisco, Mexico
Health Pharma Professional Research S.A de C.V.
Mexico City, Mexico City, Mexico
iCan Oncology Center Centro Medico AVE
Monterrey, Nuevo León, Mexico
Centro Medico Zambrano Hellion TecSalud
Monterrey, Nuevo León, Mexico
Althian - Research Management Center
San Pedro Garza García, Nuevo León, Mexico
Centro de Estudios y Prevención del Cancer AC
Juchitán de Zaragoza, Oaxaca, Mexico
Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
San Luis Potosí City, San Luis Potosí, Mexico
Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.
Culiacán, Sinaloa, Mexico
Centro de Atención e Investigación Clínica en Oncología
Mérida, Yucatán, Mexico
Centro de Investigación Médica Aguascalientes (CIMA) - Oncology
Aguascalientes, Mexico
Boca Clinical Trials México
Guadalajara, Mexico
Oncare Cancer Center Viaducto CdMx
Mexico City, Mexico
ONCOCENTER PUEBLA - Dermatology
Puebla City, Mexico
Clinical Research Institute
Tlalnepantla, Mexico
Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
Chisinau, Moldova, Republic of, Moldova
Amphia Ziekenhuis - Molengracht
Breda, North Brabant, Netherlands
Baguio General Hospital and Medical Center - Oncology
Baguio City, Benguet, Philippines
Cebu Doctors' University Hospital - Oncology
Cebu City, Cebu, Philippines
The Medical City - Clinical Research Unit
Iloilo City, Iloilo, Philippines
The Medical City - Neurology
Pasig, Metropolitan Manila, Philippines
Cagayan de Oro Medical Center - Internal Medicine
Cagayan de Oro, Misamis Oriental, Philippines
Center for Skin Research, Testing and Product Development
Makati City, National Capital Region, Philippines
Philippine General Hospital
Manila/Ermita, National Capital Region, Philippines