A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Completed · Phase 3
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT05907122
- Run by
- Amgen
- People needed
- 256
- Starts
- 2023-07-26
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous anti-cancer treatment
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Where it is running
- 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 - Oncology — Brasília, Federal District, Brazil
- Instituto de Oncologia do Parana — Curitiba, Paraná, Brazil
- Cto Centro de Tratamento Oncologico Ltda — Belém, Pará, Brazil
- PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence — 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, Valparaiso, Chile
- Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics — 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 — Naples, Italy
- Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia — Roma, Italy
- Cancer and Blood Specialty clinic — Long Beach, California, United States
Full record on ClinicalTrials.gov
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