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.
View Full Description
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.
View Eligibility Criteria
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 96 Locations for this study
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Cancer and Blood Specialty Clinic
Long Beach California, 90806, United States
Long Beach California, 90806, United States
The Lundquist Institute - Main
Torrance California, 90502, United States
Torrance California, 90502, United States
AdventHealth
Orlando Florida, 32804, United States
Orlando Florida, 32804, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
St. Vincent Frontier Cancer Crt
Billings Montana, 59102, United States
Billings Montana, 59102, United States
Clínica Viedma
Viedma Río Negro, R8500, Argentina
Viedma Río Negro, R8500, Argentina
Fundación CENIT
Caba , 1125, Argentina
Caba , 1125, Argentina
CIMMDP
Mar del Plata , 7600, Argentina
Mar del Plata , 7600, Argentina
Instituto de Oncologia de Rosario
Rosario , 2000, Argentina
Rosario , 2000, Argentina
ISIS Clinica Especializada
Santa Fe , S3000, Argentina
Santa Fe , S3000, Argentina
University Clinical Centre of the Republic of Srpska - Gastroenterology
Banjaluka Republika Srpska, 78000, Bosnia and Herzegovina
Banjaluka Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar , 88000, Bosnia and Herzegovina
Mostar , 88000, Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo , 71000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla , 75000, Bosnia and Herzegovina
Tuzla , 75000, Bosnia and Herzegovina
Cantonal hospital Zenica
Zenica , 72000, Bosnia and Herzegovina
Zenica , 72000, Bosnia and Herzegovina
Hospital Sao Rafael
Salvador Bahia, , Brazil
Salvador Bahia, , Brazil
Centro de Oncologia Leonardo da Vinci -ATO Oncologia
Fortaleza Ceará, 60140, Brazil
Fortaleza Ceará, 60140, Brazil
Hospital Sirio Libanes - Brasilia
Brasilia Distrito Federal, 70200, Brazil
Brasilia Distrito Federal, 70200, Brazil
Centro de Tratamento Oncologico
Belém Pará, 66063, Brazil
Belém Pará, 66063, Brazil
PUCRS - Hospital São Lucas
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
CEPON-Centro de Pesquisas Oncológicas
Florianopolis Santa Catarina, 88803, Brazil
Florianopolis Santa Catarina, 88803, Brazil
Hospital de Cancer de Barretos
Barretos São Paulo, 14784, Brazil
Barretos São Paulo, 14784, Brazil
Hospital e Maternidade Brasil
Sao Paulo São Paulo, CEP 0, Brazil
Sao Paulo São Paulo, CEP 0, Brazil
Fac Med de Sao Jose do Rio Preto
São José do Rio Preto São Paulo, 15090, Brazil
São José do Rio Preto São Paulo, 15090, Brazil
Instituto de Oncologia do Parana
Curitiba , , Brazil
Curitiba , , Brazil
Centro de Estudios Clínicos SAGA SpA
Santiago , 75006, Chile
Santiago , 75006, Chile
Oncocentro APYS
Viña Del Mar , 25206, Chile
Viña Del Mar , 25206, Chile
University Hospital Centre Zagreb
Zagreb Grad Zagreb, 10 00, Croatia
Zagreb Grad Zagreb, 10 00, Croatia
KBC "Sestre milosrdnice"
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Hôpital F Mitterrand - Dermatology
Dijon Côte-d'Or, 21000, France
Dijon Côte-d'Or, 21000, France
CHU de Bordeaux - Hopital Saint André
Bordeaux Gironde, 33000, France
Bordeaux Gironde, 33000, France
CHU de Poitiers
Poitiers Haute-Vienne, 21079, France
Poitiers Haute-Vienne, 21079, France
Hopital Ambroise Paré - Dermatologie
Boulogne Billancourt cedex Hauts-de-Seine, 92104, France
Boulogne Billancourt cedex Hauts-de-Seine, 92104, France
ISR-GEO Med Res Clin Healthycore
Tbilisi , 0112, Georgia
Tbilisi , 0112, Georgia
LLC "Todua Clinic"
Tbilisi , 0112, Georgia
Tbilisi , 0112, Georgia
JSC KE Nat Ctr of Exp and Clin Surg
Tbilisi , 0159, Georgia
Tbilisi , 0159, Georgia
Goethe University Hospital
Frankfurt/Main Hessen, 60590, Germany
Frankfurt/Main Hessen, 60590, Germany
University Hospital Cologne AöR
Köln Nordrhein-Westfalen, 50937, Germany
Köln Nordrhein-Westfalen, 50937, Germany
SRH Wald-Klinikum Gera gGmbH
Gera Thüringen, 07548, Germany
Gera Thüringen, 07548, Germany
Charité - Universitätsmedizin Berlin KöR
Berlin , 10117, Germany
Berlin , 10117, Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
Meldola Forli, 47014, Italy
Meldola Forli, 47014, Italy
Istituto dei Tumori "Giovanni Paolo II"
Bari , 70124, Italy
Bari , 70124, Italy
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
Bergamo , 24127, Italy
Ospedale San Raffaele, IRCCS
Milano , 20132, Italy
Milano , 20132, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , 80131, Italy
Napoli , 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Pavia , 27100, Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
Roma , 00167, Italy
Roma , 00167, Italy
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
Siena , 53100, Italy
Siena , 53100, Italy
ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi
Varese , 21100, Italy
Varese , 21100, Italy
Nagoya City University Hospital - Dermatology
Nagoya Aiti [Aichi], 467-8, Japan
Nagoya Aiti [Aichi], 467-8, Japan
Sapporo Medical University Hospital
Sapporo-Shi Hokkaidô [Hokkaido], 060-8, Japan
Sapporo-Shi Hokkaidô [Hokkaido], 060-8, Japan
NHO Kagoshima Medical Center
Kagoshima-Shi Kagosima [Kagoshima], 892-0, Japan
Kagoshima-Shi Kagosima [Kagoshima], 892-0, Japan
Shizuoka Cancer Center - Dermatology
Koto-Ku Tôkyô [Tokyo], 135-8, Japan
Koto-Ku Tôkyô [Tokyo], 135-8, Japan
Keio University Hospital - Dermatology
Shinjuku-ku Tôkyô [Tokyo], 160-8, Japan
Shinjuku-ku Tôkyô [Tokyo], 160-8, Japan
Kumamoto University Hospital - Dermatology
Kumamoto , 860-8, Japan
Kumamoto , 860-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Niigata , 951-8, Japan
Osaka International Cancer Institute - Dermatological Oncology
Osaka-shi Ôsaka [Osaka], 541-8, Japan
Osaka-shi Ôsaka [Osaka], 541-8, Japan
Inje University Haeundae Paik Hospital
Busan Busan Gwang'yeogsi [Pusan-Kwan, 48108, Korea, Republic of
Busan Busan Gwang'yeogsi [Pusan-Kwan, 48108, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 03722, Korea, Republic of
Asan Medical Center
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 06351, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukp, 06351, Korea, Republic of
Hospital Universiti Sains Malaysia
Kubang Kerian Kelantan, 16150, Malaysia
Kubang Kerian Kelantan, 16150, Malaysia
Hospital Pulau Pinang
Pulau Pinang Pahang, , Malaysia
Pulau Pinang Pahang, , Malaysia
Hospital Umum Sarawak
Kuching Sarawak, , Malaysia
Kuching Sarawak, , Malaysia
Institut Kanser Negara
Putrajaya Selangor, 62250, Malaysia
Putrajaya Selangor, 62250, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 56000, Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 56000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur Wilayah Persekutuan Kuala Lump, , Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lump, , Malaysia
Centro Inmuno Oncolog de Occidente
Guadalajara Jalisco, 44630, Mexico
Guadalajara Jalisco, 44630, Mexico
I CAN ONCOLOGY CENTER SA de CV
Monterrey Nuevo León, 64710, Mexico
Monterrey Nuevo León, 64710, Mexico
Ctro At Inv Cardio Potosi
San Luis Potosi San Luis Potosí, 78200, Mexico
San Luis Potosi San Luis Potosí, 78200, Mexico
Centro De Atenc E Inv Clín En Onco
Merida Yucatán, 97134, Mexico
Merida Yucatán, 97134, Mexico
Oncare Viaducto Napoles
Mexico City , 14080, Mexico
Mexico City , 14080, Mexico
Clinica Integral Internac Oncologia
Puebla , 72530, Mexico
Puebla , 72530, Mexico
Althian Research Management Center
San Pedro Garza Garcia , 66278, Mexico
San Pedro Garza Garcia , 66278, Mexico
Centro Medico Zambrano Hellion
San Pedro Garza García , 66278, Mexico
San Pedro Garza García , 66278, Mexico
Clinical Research Institute S.C.
Tlalnepantla de Baz , , Mexico
Tlalnepantla de Baz , , Mexico
Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht
Breda Noord-Brabant, 4818 , Netherlands
Breda Noord-Brabant, 4818 , Netherlands
Arensia - Iocn
Cluj-Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40001, Romania
Arensia - Iob
Bucuresti , 02233, Romania
Bucuresti , 02233, Romania
Vojvodina Institute for Oncology
Sremska Kamenica Vojvodina, 21204, Serbia
Sremska Kamenica Vojvodina, 21204, Serbia
Specialized hospital Oncomed System
Belgrade , 11070, Serbia
Belgrade , 11070, Serbia
Institute for Oncology and Radiology of Serbia
Beograd , , Serbia
Beograd , , Serbia
University Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Kragujevac , 34000, Serbia
University Clinical Center Nis
Nis , 18108, Serbia
Nis , 18108, Serbia
Medical Oncology Cent of Rosebank
Johannesburg Gauteng, 2196, South Africa
Johannesburg Gauteng, 2196, South Africa
Wits Clinical Research
Parktown, Johannesburg Gauteng, 2193, South Africa
Parktown, Johannesburg Gauteng, 2193, South Africa
Mary Potter Oncology Centre
Pretoria Gauteng, 0181, South Africa
Pretoria Gauteng, 0181, South Africa
Rondebosch Oncology Centre
Cape Town Western Cape, 7700, South Africa
Cape Town Western Cape, 7700, South Africa
Cape Town Oncology Trials
Kraaifontein Western Cape, 7570, South Africa
Kraaifontein Western Cape, 7570, South Africa
Hospital Universitario Virgen De La Macarena
Sevilla Andalucía, 41009, Spain
Sevilla Andalucía, 41009, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Badalona Barcelona, 08916, Spain
Hospital San Pedro de Alcántara
Caceres Cáceres, 10003, Spain
Caceres Cáceres, 10003, Spain
M.D. Anderson Center Madrid
Madrid, Madrid, 28033, Spain
Madrid, Madrid, 28033, Spain
H.U.V.Arrixaca
El Palmar Murcia, Región De, 30120, Spain
El Palmar Murcia, Región De, 30120, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 08025, Spain
Barcelona , 08025, Spain
Hospital Universitari Vall D Hebron
Barcelona , 08035, Spain
Barcelona , 08035, Spain
Hospital Clinic De Barcelona
Barcelona , 08036, Spain
Barcelona , 08036, Spain
Hospital Jerez Puerta Del Sur
Sevilla , 41009, Spain
Sevilla , 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia , 46014, Spain
Valencia , 46014, Spain
China Medical University Hospital - Internal Medicine
Taichung Taichung Municipality, 40447, Taiwan
Taichung Taichung Municipality, 40447, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
New Taipei City Taipei, 23561, Taiwan
New Taipei City Taipei, 23561, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University
Taipei , 11696, Taiwan
Taipei , 11696, Taiwan
Khon Kaen University, Srinagarind Hospital
Khonkaen Khon Kaen, 40002, Thailand
Khonkaen Khon Kaen, 40002, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Bangkok Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Siriraj Hospital
Bangkok Krung Thep Maha Nakhon [Bangko, 10700, Thailand
Bangkok Krung Thep Maha Nakhon [Bangko, 10700, Thailand
Prince of Songkla University - Faculty of Medicine
Songkhla , 90110, Thailand
Songkhla , 90110, Thailand
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