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
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
Fort Wayne, Indiana 46825, United States
Baton Rouge, Louisiana 70809, United States
East Syracuse, New York 13057, United States
Buenos Aires, Ciudad Autónoma de Buenos Aire 1125, Argentina
Mar Del Plata, Río Negro Province 7600, Argentina
Sarajevo, Kanton Sarajevo 71000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Tuzla, Tuzlanski Kanton 75000, Bosnia and Herzegovina
Estacion Central, Santiago Metropolitan 8241479, Chile
Hradec Kralove, Moravian-Silesian Region 500 05, Czechia
Poitier, Haute-Vienne 21079, France
Saida, Loubnâne Ej Jnoûbi 652, Lebanon
Putrajaya, Selangor 62250, Malaysia
Kubang Kerian, Terengganu 16150, Malaysia
Guadalajra, Jalisco 44630, Mexico
San Luis Potosí City, San Luis Potosí 78200, Mexico
Culiacán, Sinaloa 80020, Mexico
Chisinau, Moldova, Republic of MD-2025, Moldova
Makati City, National Capital Region 1229, Philippines
Manila/Ermita, National Capital Region 1000, Philippines
Lisbon, 1649-035, Portugal
Cluj-Napoca, Cluj 400015, Romania
Bucharest, 022328, Romania
Kamenitz, Vojvodina 21204, Serbia
Kragujevac, Šumadijski Okrug 34000, Serbia
Parktown, Johannesburg, Gauteng 2193, South Africa
Busan, Busan Gwang'yeogsi [Pusan-Kwan 48108, South Korea
Suwon, Gyeonggido [Kyonggi-do] 16247, South Korea
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 03722, South Korea
Badalona, Barcelona 08916, Spain
New Taipei City, Taipei 23561, Taiwan
Changhua, 50006, Taiwan
Taipei, 11696, Taiwan
Khonkaen, Changwat Khon Kaen 40002, Thailand
Muang, Chiang Mai 50200, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangko 10330, Thailand
Rajthevi, Krung Thep Maha Nakhon [Bangko 10400, Thailand
Yenimahalle/Ankara, Ankara 6500, Turkey (Türkiye)
Kadıköy, Istanbul 34722, Turkey (Türkiye)
Gaziantep, 27310, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Kocaeli, 41380, Turkey (Türkiye)