Melanoma Clinical Trial
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 40 Locations for this study
Billings Montana, 59102, United States
Santiago Región Metropolitana De Santia, 75006, Chile
Viña Del Mar , 25206, Chile
Zagreb Grad Zagreb, 10000, Croatia
Dijon Côte-d'Or, 21000, France
Bordeaux Gironde, 33000, France
Poitiers Haute-Vienne, 21079, France
Boulogne Billancourt cedex Hauts-de-Seine, 92104, France
Tbilisi , 0112;, Georgia
Tbilisi , 0112, Georgia
Tbilisi , 0159, Georgia
Gera Thüringen, 07548, Germany
Berlin , 10117, Germany
Meldola Forli-Cesena, 47014, Italy
Bari , 70124, Italy
Napoli , 80131, Italy
Siena , 53100, Italy
Nagoya Aiti [Aichi], 467-8, Japan
Kagoshima-Shi Kagosima [Kagoshima], 892-0, Japan
Shinjuku-ku Tôkyô [Tokyo], 160-8, Japan
Kumamoto , 860-8, Japan
Matsumoto-shi , 390-8, Japan
Busan Busan Gwang'yeogsi [Pusan-Kwan, 48108, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 06351, Korea, Republic of
Kubang Kerian Kelantan, 16150, Malaysia
Pulau Pinang Pahang, , Malaysia
Kuching Sarawak, , Malaysia
Putrajaya Selangor, 62250, Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 56000, Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lump, , Malaysia
Breda Noord-Brabant, 4818 , Netherlands
Beograd , , Serbia
Kragujevac , 34000, Serbia
Nis , 18108, Serbia
Cape Town Western Cape, 7700, South Africa
Kraaifontein Western Cape, 7570, South Africa
Sevilla Andalucía, 41009, Spain
El Palmar Murcia, Región De, 30120, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Sevilla , 41009, Spain
Valencia , 46014, Spain
Bangkok Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Bangkok Krung Thep Maha Nakhon [Bangko, 10700, Thailand
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