Last updated 12 days ago

A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

256 patients around the world
Available in Chile, Argentina, Brazil, Mexico
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.
Amgen
26Research sites
256Patients around the world

This study is for people with

Skin cancer
Melanoma

Requirements for the patient

To 99 Years
All Gender

Medical requirements

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
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

Sites

Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
25 de mayo 174, Viedma, Río Negro
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Juncal 2222, C1125 CABA, Argentina
Instituto de Oncología de Rosario - IOR
Recruiting
Córdoba 2457, Rosario, Santa Fe
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
Av. Colón 3083, Mar del Plata, Buenos Aires
Isis Clínica Especializada - Santa Fe
Recruiting
Urquiza 3077, Santa Fe
Hospital Sírio- Libanês Brasilia
Recruiting
SGAS 613/614 Conjunto E Lote 95, SGAS II SGAS 613 - Asa Sul, Brasília - DF, 70200-730
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Av. Ipiranga, 6690 - 4º andar - Partenon, Porto Alegre - RS, 90610-001, Brazil
Centro Pesquisas Oncologicas - CEPON
Recruiting
655 Rio Itacorubi Florianópolis SC BR 88034-000, Rod. Admar Gonzaga - Itacorubi, Florianópolis - SC
Hospital e Maternidade Brasil
Recruiting
R. Votuporanga, 111 - Vila Dora, Santo André - SP, 09030-590, Brazil
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Rua Antenor Duarte Villela 1331 - Barretos, Sao Paulo, 14784-400
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