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
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
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.
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
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.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Barretos, São Paulo 14784 400, Brazil
São Paulo, 15090-000, Brazil
Grad Zagreb, City of Zagreb 10000, Croatia
Siena, 53100, Italy
Kagoshima, Kagosima [Kagoshima] 892-0853, Japan
Shinjuku-ku, Tôkyô [Tokyo] 160-8582, Japan
Putrajaya, Selangor 62250, Malaysia
Kubang Kerian, Terengganu 16150, Malaysia
Guadalajra, Jalisco 44630, Mexico
San Luis Potosí City, San Luis Potosí 78200, Mexico
Chisinau, Moldova, Republic of MD-2025, Moldova
Cluj-Napoca, Cluj 400015, Romania
Bucharest, 022328, Romania
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
New Taipei City, Taipei 23561, Taiwan
Khonkaen, Changwat Khon Kaen 40002, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangko 10330, Thailand