Melanoma Clinical Trial
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Summary
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.
Full 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.
Eligibility Criteria
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 RECIST (version 1.1).
Tumor tissue from the resected site of disease 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.
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There are 69 Locations for this study
Fort Wayne Indiana, 46804, United States
Baton Rouge Louisiana, 70805, United States
Baltimore Maryland, 21201, United States
Springfield Missouri, 65807, United States
East Syracuse New York, 13057, United States
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
Mostar , 88000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Tuzla , 75000, Bosnia and Herzegovina
Zenica , 72000, Bosnia and Herzegovina
Fredericton New Brunswick, E3B 5, Canada
Zagreb Grad Zagreb, 10 00, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Osijek Osjecko-baranjska Županija, 31000, Croatia
Hradec Kralove , 500 0, Czechia
Praha 2 , 128 0, Czechia
Tallinn , , Estonia
Tartu , 51014, Estonia
Poitiers Haute-Vienne, 21079, France
Lille Nord, 59037, France
Tbilisi , 0112, Georgia
Tbilisi , 0112, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0186, Georgia
Taormina Messina, 98039, Italy
Firenze , 50134, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Pavia , 27100, Italy
Roma , 00144, Italy
Roma , 00167, Italy
Siena , 53100, Italy
Varese , 21100, Italy
Vilnius , LT-08, Lithuania
Kubang Kerian Kelantan, 16150, Malaysia
Pulau Pinang Pahang, , Malaysia
Kuching Sarawak, , Malaysia
Putrajaya Selangor, 62250, Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 56000, Malaysia
Leon Guanajuato, C. P., Mexico
Guadalajara Jalisco, 44630, Mexico
Monterrey Nuevo León, 64710, Mexico
Juchitan Oaxaca, 70000, Mexico
San Luis Potosi San Luis Potosí, 78200, Mexico
Culiacan Sinaloa, 80020, Mexico
Merida Yucatán, 97134, Mexico
Guadalajara , , Mexico
Mexico City , 14080, Mexico
Puebla , 72530, Mexico
San Pedro Garza Garcia , 66278, Mexico
San Pedro Garza García , 66278, Mexico
Tlalnepantla de Baz , , Mexico
Lisboa , 1449-, Portugal
Lisboa , 1500-, Portugal
Lisboa , , Portugal
Cluj-Napoca Cluj, 40001, Romania
Floresti Cluj, 40728, Romania
Craiova Dolj, 20074, Romania
Timisoara Timis, 30016, Romania
Cluj-Napoca , 40064, Romania
Iasi , 70010, Romania
Sibiu , 55024, Romania
Sremska Kamenica Vojvodina, 21204, Serbia
Sevilla Andalucía, 41009, Spain
Badalona Barcelona, 08916, Spain
Caceres Cáceres, 10003, Spain
Madrid, Madrid, 28033, Spain
El Palmar Murcia, Región De, 30120, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Málaga , 29011, Spain
Sevilla , 41009, Spain
Valencia , 46014, Spain
Khonkaen Khon Kaen, 40002, Thailand
Bangkok Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Bangkok Krung Thep Maha Nakhon [Bangko, 10700, Thailand
Songkhla , 90110, Thailand
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