A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
NCT ID: NCT06054555
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
620 participants
INTERVENTIONAL
2023-11-02
2028-01-25
Brief Summary
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Detailed Description
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All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.
The total duration of study participation for each subject will be approximately 26 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ABP 206
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
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
Subjects will receive Dose A of Nivolumab via IV infusion.
Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed unresectable or metastatic melanoma.
* Subject has no prior systemic treatment for advanced disease.
* Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
* Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Exclusion Criteria
* Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
* Subject has active central nervous system (CNS) metastases not previously treated.
* Ocular melanoma.
* Subject has active or known immune-mediated disorders.
* Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
* Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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-CNY
East Syracuse, New York, United States
Fundación CENIT
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
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
East Tallinn Central Hospital
Tallinn, Harju, Estonia
Tartu University Hospital
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
High Technology Hospital MedCenter LTD
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
Pecsi Tudomanyegyetem/ Klinikai Kozpont Bor-, Nemikortani es Onkodermatologiai Klinika
Pécs, Baranya, Hungary
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
Milan, , Italy
AOU Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare
Napoli, , 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
Osp Isola Tiberina-Gemelli Isola
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
Institut Kanser Negara
Putrajaya, Selangor, Malaysia
Hospital Universiti Sains Malaysia
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
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Preparaciones Oncologicas 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
Cardinal Santos Madical Center
San Juan City, National Capital Region, Philippines
Riverside Medical Center
Bacolod, Negros Occidental, Philippines
Centro Hospitalar de Setúbal - Oncologia
Setúbal, Setúbal District, Portugal
Champalimaud Cancer Center
Lisbon, , Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Lisbon, , Portugal
Hospital da Luz
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
Lisbon, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
Lisbon, , Portugal
Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica
Porto, , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Medisprof - Medical Oncology
Cluj-Napoca, Cluj, Romania
Radiotherapy Center Cluj - Medical Oncology
Floreşti, Cluj, Romania
Oncolab - Medical Oncology
Craiova, Dolj, Romania
Centrul de Oncologie Sf Nectarie - Medical Oncology
Craiova, Dolj, Romania
Medical Center Gral
Ploieşti, Prahova, Romania
Spitalul Municipal Ploiesti
Ploieşti, Prahova, Romania
Oncocenter- Oncologie Clinica - Medical Oncology
Timișoara, Timiș County, Romania
Memorial Healthcare International - Oncology
Bucharest, , Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucharest, , Romania
Centrul de Oncologie Euroclinic
Iași, , Romania
Spitalul Clinic Judetean De Urgenta Sibiu
Sibiu, , Romania
Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B
Kamenitz, Vojvodina, Serbia
University Clinical Center of Kragujevac, Center for Internal Oncology
Kragujevac, Šumadijski Okrug, Serbia
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Wits Clinical Research
Parktown, Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital
Pretoria, Gauteng, South Africa
Curo Oncology
Pretoria, Gauteng, South Africa
Little Company Of Mary Hospital - Oncology
Pretoria, Gauteng, South Africa
Rainbow Oncology Centre
Durban, KwaZulu-Natal, South Africa
Cape Gate Oncology Centre
Bellville, Western Cape, South Africa
Cancercare - Rondebosch Oncology
Cape Town, Western Cape, South Africa
Inje University Haeundae Paik Hospital - Oncology
Busan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido [Kyonggi-do], South Korea
Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Asan Medical Center - Oncology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Samsung Medical Center - Family Medicine
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Hospital Universitario Virgen de la Macarena - Oncología Médica
Seville, Andalusia, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica
Badalona, Barcelona, Spain
Hospital San Pedro de Alcántara - Oncología
Cáceres, Cáceres, Spain
H.U.V.Arrixaca
El Palmar, Murcia, Región de, Spain
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau - Oncología Médica
Barcelona, , Spain
M.D. Anderson Center Madrid
Madrid, , Spain
Hospital Regional Universitario de Malaga - Servicio de Oncología
Málaga, , Spain
Hospital HLA Jerez Puerta Sur
Seville, , Spain
Consorcio Hospital General Universitario de Valencia - Oncología
Valencia, , Spain
China Medical University Hospital - Internal Medicine
Taichung, Taichung Municipality, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
New Taipei City, Taipei, Taiwan
Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine
Changhua, , Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
Taipei, , Taiwan
Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
Khonkaen, Changwat Khon Kaen, Thailand
Prince of Songkla University
Songkhla, Changwat Songkhla, Thailand
Maharaj Nakorn Chiangmai Hospital - Medical Oncology
Muang, Chiang Mai, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Ramathibodi Hospital - Immunology and Rheumatology
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Siriraj Hospital - Medical Oncology
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Gazi University Medical Faculty - Gynecology
Yenimahalle/Ankara, Ankara, Turkey (Türkiye)
Goztepe SuleymanYalcin Sehir Hast
Kadıköy, Istanbul, Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital - Medical Oncology
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara Liv Hospital
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
Ankara, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Medical Point Gaziantep Hospital
Gaziantep, , Turkey (Türkiye)
Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and
Gaziantep, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egt. Ars Hast.
Istanbul, , Turkey (Türkiye)
Koc Universitesi Hastanesi; Tıbbi Onkoloji
Istanbul, , Turkey (Türkiye)
Memorial Bahçelievler Hospital
Istanbul, , Turkey (Türkiye)
Izmir Medical Point Hastanesi
Izmir, , Turkey (Türkiye)
Kocaeli University Research and Practice Hospital - Medical Oncology
Kocaeli, , Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty - Oncology
Konya, , Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, , Turkey (Türkiye)
VM Medical Park Samsun Hospital - Medical oncology
Samsun, , Turkey (Türkiye)
Namik Kemal Universitesi - Tip Fakultesi
Tekirdağ, , Turkey (Türkiye)
TOV "ARENSIIa EKSPLORATORI MEDISIN"
Kyiv, Kyïv, Ukraine
Hanoi Oncology Hospital
Hanoi, Ha Noi, Thu Do, Vietnam
Vietnam National Cancer Hopsital
Hanoi, Ha Noi, Thu Do, Vietnam
HCM Oncology Hospital - Medical Oncology
Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-503288-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20210031
Identifier Type: -
Identifier Source: org_study_id