A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: ABP 206; Drug: Nivolumab

Detailed Description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

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.

• Study Type: Interventional
• Enrollment (Actual): 633
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe, Argentina, S3000FFU
    • ISIS Clinica Especializada
  • Ciudad Autónoma de Buenos Aire
    • Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina, 1125
      • Centro de Investigaciones Medicas y Desarrollo LC
  • Río Negro Province
    • Mar Del Plata, Río Negro Province, Argentina, 7600
      • Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
    • Viedma, Río Negro Province, Argentina, R8500JYJ
      • Clínica Viedma - Oncology
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Instituto de Oncología de Rosario
• Bosnia and Herzegovina
  • Kanton Sarajevo
    • Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000
      • Clinical Center University of Sarajevo - Clinic of Oncology
  • Republika Srpska
    • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
      • University Clinical Center of Republic of Srpska
  • Tuzlanski Kanton
    • Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina, 75000
      • University Clinical Center Tuzla - Oncology, Hematology and Radio
  • Zeničko-dobojski Kanton
    • Zenica, Zeničko-dobojski Kanton, Bosnia and Herzegovina, 72000
      • Cantonal hospital Zenica - Oncology
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Dr. Everett Chalmers Hospital - Oncology
• Chile
  • Coquimbo Region
    • La Serena, Coquimbo Region, Chile, 1720430
      • IC La Serena Research
  • Región de Valparaíso
    • Valparaíso, Región de Valparaíso, Chile, 2363058
      • Oncocentro Apys
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4810218
      • Centro de Investigacion y Desarrollo Oncologico
  • Santiago Metropolitan
    • Estacion Central, Santiago Metropolitan, Chile, 8241479
      • Icegclinic Research & Care
• Croatia
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10 000
      • University Hospital Centre Zagreb - Oncology department
    • Zagreb, City of Zagreb, Croatia, 10000
      • Poliklinika Anova
  • Osjecko-baranjska Županija
    • Osijek, Osjecko-baranjska Županija, Croatia, 31000
      • Klinicki bolnicki centar Osijek
• Czechia
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka
  • Moravskoslezský kraj
    • Hradec Kralove, Moravskoslezský kraj, Czechia, 500 05
      • FN Hradec Kralove - Klinika onkologie a radioterap
• Estonia
  • Tartu
    • Tartu, Tartu, Estonia, 51014
      • Tartu University Hospital - Oncology
• France
  • Haute-Vienne
    • Poitier, Haute-Vienne, France, 21079
      • CHU De Poitiers
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35042
      • Centre Hospitalier De Saint Malo - Oncologie
  • Nord
    • Lille, Nord, France, 59037
      • C.H.R.U Hopital Claude Huriez - Dermatologie
• Georgia
  • Tbilisi, Georgia, 0112
    • LLC "Todua Clinic"
  • Tbilisi, Georgia, 0112
    • LTD "Israel-Georgian Medical Research Clinic Healthycore"
  • Tbilisi, Georgia, 0159
    • JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
  • Tbilisi, Georgia, 0186
    • LTD "Multprofile Clinic Consilium Medulla" - Oncology
  • Adjara
    • Batumi, Adjara, Georgia, 6010
      • LTD "High Technology Hospital Medcenter"
• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Goethe University Frankfurt
    • Marburg, Hesse, Germany, 35043
      • Philipps-University Marburg
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • University Hospital of Cologne
• Italy
  • Alessandria, Italy, 15121
    • AO Ss Antonio, Biagio e Arrigo
  • Bari, Italy, 70124
    • AUO Consorziale-Policlinico Bari
  • Bari, Italy, 70124
    • Istituto dei Tumori Giovanni Paolo II - Oncologia Medica - Tumori Rari e Melanoma
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII - Oncologia
  • Florence, Italy, 50134
    • AOU Careggi
  • Milan, Italy, 20122
    • IRCCS Ca'Granda Maggiore Policlinic
  • Milan, Italy, 20132
    • Ospedale San Raffaele, IRCCS - Oncologia Medica
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Napoli, Italy, 80131
    • AOU Luigi Vanvitelli
  • Napoli, Italy, 80147
    • Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova
  • Roma, Italy, 00167
    • Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica
  • Roma, Italy, 00144
    • IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
  • Roma, Italy, 00186
    • Ospedale Isola Tiberina - Gemelli Isola - Oncologia Medica
  • Siena, Italy, 53100
    • AOU Senese, Policlinico Le Scotte
  • Varese, Italy, 21100
    • Ospedale di Circolo, Presidio di Varese - Oncologia
  • Cremona
    • Crema, Cremona, Italy, 26013
      • Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico
  • Forli
    • Meldola, Forli, Italy, 47014
      • IRST Dino Amadori (IRST IRCCS) - UNK
  • Messina
    • Taormina, Messina, Italy, 98039
      • PO Ospedale San Vincenzo - Oncologia Medica
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
• Jordan
  • Amman, Jordan, 11941.0
    • King Hussein Cancer Center
  • Irbid, Jordan
    • Pharmaceutical Research Center (KAUH)
  • 'Ammān
    • Amman, 'Ammān, Jordan
      • Al Khalidi Hospital and Medical Center - Research
    • Amman, 'Ammān, Jordan
      • The Speciality Hospital (TSH) / Advanced Clinical Center
• Lebanon
  • Beirut, Lebanon, +961
    • Ain Wazein Hospital - internal medicine
  • Beirut, Lebanon, 00000
    • American University of Beirut Medical Center - Haematology
  • Beirut, Lebanon, 111
    • Hotel Dieu de France Hospital - Oncology
  • Beyrouth
    • El Achrafiyé, Beyrouth, Lebanon, 00000
      • Saint George Hospital University Medical Center
  • Loubnâne Ech Chemâli
    • Tripoli, Loubnâne Ech Chemâli, Lebanon, 00000
      • Nini Hospital
  • Loubnâne Ej Jnoûbi
    • Saida, Loubnâne Ej Jnoûbi, Lebanon, 652
      • Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology
• Lithuania
  • Vilnius County
    • Vilnius, Vilnius County, Lithuania, LT-08660
      • National Cancer Institute - Conservative Tumour Therapy
• Malaysia
  • Pahang
    • Pulau Pinang, Pahang, Malaysia, 00000
      • Hospital Pulau Pinang
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital
  • Selangor
    • Putrajaya, Selangor, Malaysia, 62250
      • National Cancer Institute - Radiotherapy and Oncology
  • Terengganu
    • Kubang Kerian, Terengganu, Malaysia, 16150
      • HOSPITAL UNIVERSITI SAINS MALAYSIA - Pediatrics
  • Wilayah Persekutuan Kuala Lump
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz UKM
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 00000
      • Hospital Kuala Lumpur - Surgery
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 59100
      • Pantai Hospital Kuala Lumpur - Oncology
• Mexico
  • Aguascalientes, Mexico, 68000
    • Centro de Investigación Médica Aguascalientes (CIMA) - Oncology
  • Guadalajara, Mexico, 00000
    • Boca Clinical Trials México
  • Mexico City, Mexico, 14080
    • Oncare Cancer Center Viaducto CdMx
  • Puebla City, Mexico, 72530
    • ONCOCENTER PUEBLA - Dermatology
  • Tlalnepantla, Mexico, 54055
    • Clinical Research Institute
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Preparaciones Oncologica SC
  • Jalisco
    • Guadalajra, Jalisco, Mexico, 44630
      • Centro de Inm Onc de Occ Sa de Cv
  • Mexico City
    • Mexico City, Mexico City, Mexico, 3100
      • Health Pharma Professional Research S.A de C.V.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • iCan Oncology Center Centro Medico AVE
    • Monterrey, Nuevo León, Mexico, 66278
      • Centro Medico Zambrano Hellion TecSalud
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • Althian - Research Management Center
  • Oaxaca
    • Juchitán de Zaragoza, Oaxaca, Mexico, 70000
      • Centro de Estudios y Prevención del Cancer AC
  • San Luis Potosí
    • San Luis Potosí City, San Luis Potosí, Mexico, 78200
      • Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97130
      • Centro de Atención e Investigación Clínica en Oncología
• Moldova
  • Moldova, Republic of
    • Chisinau, Moldova, Republic of, Moldova, MD-2025
      • Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
• Netherlands
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis - Molengracht
• Philippines
  • Benguet
    • Baguio City, Benguet, Philippines, 2600
      • Baguio General Hospital and Medical Center - Oncology
  • Cebu
    • Cebu City, Cebu, Philippines, 1000
      • Cebu Doctors' University Hospital - Oncology
  • Iloilo
    • Iloilo City, Iloilo, Philippines, 00000
      • The Medical City - Clinical Research Unit
  • Metropolitan Manila
    • Pasig, Metropolitan Manila, Philippines, 1605
      • The Medical City - Neurology
  • Misamis Oriental
    • Cagayan de Oro, Misamis Oriental, Philippines, 9000
      • Cagayan de Oro Medical Center - Internal Medicine
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1229
      • Center for Skin Research, Testing and Product Development
    • Manila/Ermita, National Capital Region, Philippines, 1000
      • Philippine General Hospital
    • San Juan City, National Capital Region, Philippines, 1502
      • Cardinal Santos Madical Center
  • Negros Occidental
    • Bacolod, Negros Occidental, Philippines, 6100
      • Riverside Medical Center
• Portugal
  • Lisbon, Portugal, 1400-038
    • Champalimaud Cancer Center
  • Lisbon, Portugal, 1449-005
    • Unidade Local De Saúde De Lisboa Ocidental E.P.E.
  • Lisbon, Portugal, 1649-035
    • 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
  • Porto, Portugal, 4200-072
    • Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica
  • Setúbal District
    • Setúbal, Setúbal District, Portugal, 2910446
      • Centro Hospitalar de Setúbal - Oncologia
• Romania
  • Bucharest, Romania, 013823
    • Memorial Healthcare International - Oncology
  • Bucharest, Romania, 022328
    • Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Medical Oncology I
  • Iași, Romania, 700106
    • Centrul de Oncologie Euroclinic - Oncology
  • Sibiu, Romania, 550245
    • Spitalul Clinic Judetean de Urgenta Sibiu - Oncologie
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Medical Oncology
    • Cluj-Napoca, Cluj, Romania, 400641
      • Medisprof - Medical Oncology
    • Floreşti, Cluj, Romania, 407280
      • Radiotherapy Center Cluj - Medical Oncology
  • Dolj
    • Craiova, Dolj, Romania, 200385
      • Oncolab - Medical Oncology
    • Craiova, Dolj, Romania, 200746
      • Centrul de Oncologie Sf Nectarie - Medical Oncology
  • Prahova
    • Ploieşti, Prahova, Romania, 100010
      • Medical Center Gral
    • Ploieşti, Prahova, Romania, 100337
      • Spitalul Municipal Ploiesti - Oncologie
  • Timiș County
    • Timișoara, Timiș County, Romania, 300166
      • Oncocenter- Oncologie Clinica - Medical Oncology
• Serbia
  • Vojvodina
    • Kamenitz, Vojvodina, Serbia, 21204
      • Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B
  • Šumadijski Okrug
    • Kragujevac, Šumadijski Okrug, Serbia, 34000
      • University Clinical Center of Kragujevac, Center for Internal Oncology
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • The Medical Oncology Centre of Rosebank
    • Johannesburg, Gauteng, South Africa, 2193
      • Chris Hani Baragwanath Academic Hospital
    • Parktown, Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
    • Pretoria, Gauteng, South Africa, 0084
      • Curo Oncology
    • Pretoria, Gauteng, South Africa, 0002
      • Steve Biko Academic Hospital
    • Pretoria, Gauteng, South Africa, 0181
      • Little Company Of Mary Hospital - Oncology
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4058
      • Rainbow Oncology Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7700
      • Cancercare - Rondebosch Oncology
    • Cape Town, Western Cape, South Africa, 7570
      • Cape Gate Oncology Centre
• South Korea
  • Busan Gwang'yeogsi [Pusan-Kwan
    • Busan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea, 48108
      • Inje University Haeundae Paik Hospital - Oncology
  • Gyeonggido [Kyonggi-do]
    • Suwon, Gyeonggido [Kyonggi-do], South Korea, 16247
      • The Catholic university of Korea, St. Vincent's Hospital
  • Seoul Teugbyeolsi [Seoul-T'ukp
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 03722
      • Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 05505
      • Asan Medical Center - Oncology
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 06351
      • Samsung Medical Center - Family Medicine
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau - Oncología Médica
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron - Oncología Médica
  • Madrid, Spain, 28033
    • M.D. Anderson Center Madrid
  • Málaga, Spain, 29011
    • Hospital Regional Universitario de Malaga - Servicio de Oncología
  • Seville, Spain, 41009
    • Hospital HLA Jerez Puerta Sur
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia - Oncología
  • Andalusia
    • Seville, Andalusia, Spain, 41009
      • Hospital Universitario Virgen de la Macarena - Oncología Médica
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica
  • Cáceres
    • Cáceres, Cáceres, Spain, 10003
      • Hospital San Pedro de Alcántara - Oncología
  • Murcia, Región de
    • El Palmar, Murcia, Región de, Spain, 30120
      • H.U.V.Arrixaca - Oncología
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine
  • Taipei, Taiwan, 11696
    • Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
  • Taichung Municipality
    • Taichung, Taichung Municipality, Taiwan, 40447
      • China Medical University Hospital - Internal Medicine
  • Taipei
    • New Taipei City, Taipei, Taiwan, 23561
      • Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
• Thailand
  • Changwat Khon Kaen
    • Khonkaen, Changwat Khon Kaen, Thailand, 40002
      • Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
  • Changwat Songkhla
    • Songkhla, Changwat Songkhla, Thailand, 90110
      • Prince of Songkla University
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiangmai Hospital - Medical Oncology
  • Krung Thep Maha Nakhon [Bangko
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10330
      • King Chulalongkorn Memorial Hospital [Medical Oncology]
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10700
      • Siriraj Hospital - Medical Oncology
    • Rajthevi, Krung Thep Maha Nakhon [Bangko, Thailand, 10400
      • Ramathibodi Hospital - Immunology and Rheumatology
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Adana City Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital - Medical Oncology
  • Ankara, Turkey (Türkiye), 06590
    • Ankara University Medical Faculty - Medical Oncology
  • Ankara, Turkey (Türkiye), 06680
    • Ankara Liv Hospital
  • Ankara, Turkey (Türkiye), 6520
    • Memorial Ankara Hospital - Oncology
  • Ankara, Turkey (Türkiye)
    • Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Medical Faculty
  • Gaziantep, Turkey (Türkiye), 27010
    • Medical Point Gaziantep Hospital - Medical Oncology
  • Gaziantep, Turkey (Türkiye), 27310
    • Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and
  • Istanbul, Turkey (Türkiye), 34098
    • Bakirköy Dr. Sadi Konuk EÄŸitim ve AraÅŸtirma Hastanesi - Oncology
  • Istanbul, Turkey (Türkiye), 34510
    • Koc Universitesi Hastanesi; Tıbbi Onkoloji
  • Istanbul, Turkey (Türkiye), 44280
    • Memorial Bahçelievler Hospital
  • Izmir, Turkey (Türkiye), 35560
    • Izmir Medical Point Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Research and Practice Hospital - Medical Oncology
  • Konya, Turkey (Türkiye), 42080
    • Necmettin Erbakan University Meram Medical Faculty - Oncology
  • Sakarya, Turkey (Türkiye), 54290
    • Sakarya Training and Research Hospital
  • Samsun, Turkey (Türkiye), 00000
    • VM Medical Park Samsun Hospital - Medical oncology
  • Tekirdağ, Turkey (Türkiye), 59100
    • Namik Kemal Universitesi - Tip Fakultesi
  • Ankara
    • Yenimahalle/Ankara, Ankara, Turkey (Türkiye), 6500
      • Gazi University Medical Faculty - Gynecology
  • Istanbul
    • Kadıköy, Istanbul, Turkey (Türkiye), 34722
      • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
• Ukraine
  • Kyïv
    • Kyiv, Kyïv, Ukraine, 1135
      • TOV "ARENSIIa EKSPLORATORI MEDISIN"
• United States
  • California
    • Long Beach, California, United States, 90806
      • Cancer and Blood Specialty Clinic
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
  • Missouri
    • Springfield, Missouri, United States, 65807-5287
      • Oncology Hematology Associates
  • New York
    • East Syracuse, New York, United States, 13057
      • Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP
• Vietnam
  • Ha Noi, Thu Do
    • Hanoi, Ha Noi, Thu Do, Vietnam, 100000
      • Hanoi Oncology Hospital
    • Hanoi, Ha Noi, Thu Do, Vietnam, 10000
      • Vietnam National Cancer Hopsital
  • Ho Chi Minh, Thanh Pho [Sai Go
    • Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam
      • HCM Oncology Hospital - Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• At least 18 years of age.
• 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.

Key Exclusion Criteria:

• Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
• 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.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP 206; Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.	Drug: 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.
Active Comparator: Nivolumab; Subjects will receive Dose A of Nivolumab via IV infusion.	Drug: Nivolumab; Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.; Other Names: OPDIVO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response by Week 49	Week 49
Objective response at Week 17	Week 17
Progression-free survival (PFS)	From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with treatment-emergent adverse events	Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events	Week 1 until Week 105
Number of subjects with treatment-emergent adverse events of interest	Week 1 until Week 105
Number of subjects with anti-drug antibodies	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Serum concentrations of ABP 206 and nivolumab (Ctrough)	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): January 25, 2028

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic melanoma; Unresectable melanoma; Treatment-naive
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab
• Other Study ID Numbers: 20210031; 2023-503288-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues, and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No