A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
NCT ID: NCT05907122
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2023-07-26
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 minutes, every 4 weeks (Q4W) for a total of 12 months.
FDA-licensed Nivolumab
Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
FDA-licensed Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
EU-authorized Nivolumab
Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
EU-authorized Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABP 206
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
FDA-licensed Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
EU-authorized Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Completely removed melanoma by surgery performed within 12 weeks of randomization
* Advanced Melanoma
* Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria
* Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
* Ocular or uveal melanoma or history of carcinomatosis meningitis
* History of auto-immune disease
* Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer and Blood Specialty clinic
Long Beach, California, United States
St. Vincent Frontier Cancer Center - Oncology
Billings, Montana, United States
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
Mar Del Plata, Río Negro Province, Argentina
Clinical Center University of Sarajevo - Clinic of Oncology
Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska - Gastroenterology
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
University Clinical Hospital Mostar - Clinic for Lung Diseases
Mostar, , Bosnia and Herzegovina
ATO Oncologia
Fortaleza, Ceará, Brazil
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Hospital Sirio Libanes - Brasilia
Brasília, Federal District, Brazil
Instituto de Oncologia do Parana
Curitiba, Paraná, Brazil
CTO Centro de Tratamento Oncológico
Belém, Pará, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos, São Paulo, Brazil
Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology
São Paulo, , Brazil
Oncocentro APYS
Valparaíso, Región de Valparaíso, Chile
KBC "Sestre milosrdnice"
Grad Zagreb, City of Zagreb, Croatia
University Hospital Centre Zagreb - Oncology department
Zagreb, City of Zagreb, Croatia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, , Georgia
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, , Georgia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
Meldola, Forli, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
Roma, , Italy
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
Siena, , Italy
Nagoya City University Hospital - Dermatology
Nagoya, Aiti [Aichi], Japan
Sapporo Medical University Hospital
Sapporo, Hokkaidô [Hokkaido], Japan
National Hospital Organization Kagoshima Medical Center - Haematology
Kagoshima, Kagosima [Kagoshima], Japan
Shizuoka Cancer Center - Dermatology
Kōtoku, Tôkyô [Tokyo], Japan
Keio University Hospital - Dermatology
Shinjuku-ku, Tôkyô [Tokyo], Japan
Kumamoto University Hospital - Dermatology
Kumamoto, , Japan
Niigata Cancer Center Hospital - Dermatology
Niigata, , Japan
Osaka International Cancer Institute - Dermatological Oncology
Osaka, Ôsaka [Osaka], Japan
National Cancer Institute - Conservative Tumour Therapy
Vilnius, Vilnius County, Lithuania
Hospital Pulau Pinang - Rheumatology
Pulau Pinang, Pahang, Malaysia
Hospital Umum Sarawak
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
Centro de Inm Onc de Occ Sa de Cv
Guadalajra, Jalisco, Mexico
Althian - Research Management Center
San Pedro Garza García, Nuevo León, Mexico
Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
San Luis Potosí City, San Luis Potosí, 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 Hospital - unspecified
Breda, North Brabant, Netherlands
Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On
Cluj-Napoca, Cluj, Romania
Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures
Bucharest, , Romania
University Clinical Center of Nis, Clinic for Oncology
Niš, Nišavski Okrug, Serbia
Institute for Oncology and Radiology of Serbia, Department for Lung Cancer
Belgrade, , Serbia
University Clinical Center of Kragujevac, Center for Internal Oncology
Kragujevac, Šumadijski Okrug, Serbia
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Wits Clinical Research
Parktown, Johannesburg, Gauteng, South Africa
Mary Potter Oncology Centre
Pretoria, Gauteng, 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
Hospital San Pedro de Alcántara - Oncología
Cáceres, Cáceres, Spain
H.U.V.Arrixaca
El Palmar, Murcia, Región de, Spain
Hospital de la Santa Creu i Sant Pau - Oncología Médica
Barcelona, , 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
Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
Khonkaen, Changwat Khon Kaen, Thailand
Prince of Songkla University
Songkhla, Changwat Songkhla, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Siriraj Hospital - Medical Oncology
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
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
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20220083
Identifier Type: -
Identifier Source: org_study_id