NCT05907122CompletedPhase 3
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (actual)
- First submitted
- 8 Jun 2023
- Start date
- 26 Jul 2023
- Primary completion date
- 26 Mar 2025
- Lead sponsor
- Amgen
- Diseases
- Melanoma
- NCT number
- NCT05907122
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 256
- From 26 Jul 2023 to the primary completion date, 26 Mar 2025
- 76 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous anti-cancer treatment
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Other illness
- 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
Who the study is looking for
- At least 18 years of age
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology Coordinator of this site? Confirm its status | Mar Del Plata | Argentina | Unknown status |
| Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| CTO Centro De Tratamento Oncologico LTDA Coordinator of this site? Confirm its status | Belém | Brazil | Unknown status |
| Hospital Sirio Libanes - Brasilia - Oncology Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Instituto de Oncologia do Parana Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| CEPON - Centro de Pesquisas Oncologicas Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| ATO Oncologia Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Rafael Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Oncocentro Apys Coordinator of this site? Confirm its status | Valparaíso | Chile | Unknown status |
| Hospital de la Santa Creu I Sant Pau Oncología Medica Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital San Pedro De Alcantara | Oncologia Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| H.U.V.Arrixaca - Oncología Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital HLA Jerez Puerta Sur Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Consorcio Hospital General Universitario de Valencia - Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| LTD "Israel-Georgian Medical Research Clinic Healthycore" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Unknown status |
| University Hospital Centre Zagreb - Oncology department Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncolo Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| National Hospital Organization Kagoshima Medical Center - Haematology Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Shizuoka Cancer Center - Dermatology Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| Kumamoto University Hospital - Dermatology Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Nagoya City University Hospital - Dermatology Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata Cancer Center Hospital - Dermatology Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Osaka International Cancer Institute - Dermatological Oncology Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Keio University Hospital - Dermatology Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Inje University Haeundae Paik Hospital - Oncology Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center - Oncology Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center - Family Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| National Cancer Institute - Conservative Tumour Therapy Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Centro de Inm Onc de Occ Sa de Cv Coordinator of this site? Confirm its status | Guadalajra | Mexico | Unknown status |
| ONCOCENTER PUEBLA - Dermatology Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| Hospital Angeles Centro Médico San Luis Potosí - Cardiologia Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Althian - Research Management Center Coordinator of this site? Confirm its status | San Pedro Garza García | Mexico | Unknown status |
| Clinical Research Institute Coordinator of this site? Confirm its status | Tlalnepantla | Mexico | Unknown status |
| Hospital Kuala Lumpur - Surgery Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kubang Kerian | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Hospital Pulau Pinang - Rheumatology Coordinator of this site? Confirm its status | Pulau Pinang | Malaysia | Unknown status |
| National Cancer Institute - Radiotherapy and Oncology Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Amphia Hospital - unspecified Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Institute for Oncology and Radiology of Serbia, Department for Lung Cancer Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Center of Kragujevac, Center for Internal Oncology Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| University Clinical Center of Nis, Clinic for Oncology Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| King Chulalongkorn Memorial Hospital [Medical Oncology] Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital - Medical Oncology Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO) Coordinator of this site? Confirm its status | Khonkaen | Thailand | Unknown status |
| Prince of Songkla University Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| China Medical University Hospital - Internal Medicine Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| St. Vincent Frontier Cancer Center - Oncology Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Cancer and Blood Specialty clinic Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Vietnam National Cancer Hopsital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| HCM Oncology Hospital - Medical Oncology Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Cancercare Rondebosch Oncology Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Cape Gate Oncology Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| The Medical Oncology Centre of Rosebank Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Wits Clinical Research Coordinator of this site? Confirm its status | Parktown, Johannesburg | South Africa | Unknown status |
| Mary Potter Oncology Centre Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| University Clinical Centre of the Republic of Srpska - Gastroenterology Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
| University Clinical Hospital Mostar - Clinic for Lung Diseases Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Unknown status |
| Clinical Center University of Sarajevo - Clinic of Oncology Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
| University Clinical Center Tuzla - Oncology, Hematology and Radio Coordinator of this site? Confirm its status | Tuzla | Bosnia and Herzegovina | Unknown status |
| Cantonal hospital Zenica - Oncology Coordinator of this site? Confirm its status | Zenica | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.