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A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 99 Years |
| Gender | All |
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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05907122 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Amgen |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
MD |
| Principal Investigator Affiliation | Amgen |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Bosnia and Herzegovina, Brazil, Chile, Croatia, France, Georgia, Germany, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Moldova, Republic of, Netherlands, Romania, Serbia, South Africa, Spain, Taiwan, Thailand, United States, Vietnam |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
| Study Website: | View Trial Website |
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.
Arms
Experimental: ABP 206
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Active Comparator: FDA-licensed Nivolumab
Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
Active Comparator: EU-authorized Nivolumab
Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
Interventions
Drug: - ABP 206
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
Drug: - FDA-licensed Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Drug: - EU-authorized Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Cancer and Blood Specialty Clinic
Long Beach, California, 90806
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The Lundquist Institute - Main
Torrance, California, 90502-2004
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Address
AdventHealth
Orlando, Florida, 32804
Status
Address
University of Maryland Medical Center-Greenebaum Cancer Ctr
Baltimore, Maryland, 21201
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Address
St. Vincent Frontier Cancer Crt
Billings, Montana, 59102-6746
International Sites
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Clínica Viedma
Viedma, Río Negro, R8500ACE
Status
Address
Fundación CENIT
Caba, , 1125
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Address
CIMMDP
Mar del Plata, , 7600
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Address
Instituto de Oncologia de Rosario
Rosario, , 2000
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Address
ISIS Clinica Especializada
Santa Fe, , S3000FFU
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Address
University Clinical Centre of the Republic of Srpska - Gastroenterology
Banjaluka, Republika Srpska, 78000
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Address
University Clinical Hospital Mostar
Mostar, , 88000
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Clinical Center University of Sarajevo
Sarajevo, , 71000
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University Clinical Center Tuzla
Tuzla, , 75000
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Cantonal hospital Zenica
Zenica, , 72000
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Hospital Sao Rafael
Salvador, Bahia,
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Address
Centro de Oncologia Leonardo da Vinci -ATO Oncologia
Fortaleza, Ceará, 60140-025
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Address
Hospital Sirio Libanes - Brasilia
Brasilia, Distrito Federal, 70200 730
Status
Address
Centro de Tratamento Oncologico
Belém, Pará, 66063-495
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Address
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, 90610-000
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Address
CEPON - Centro de Pesquisas Oncológicas
Florianopolis, Santa Catarina, 888034-000
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Address
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784 400
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Address
Hospital e Maternidade Brasil
Sao Paulo, São Paulo, CEP 04501-000
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Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
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Address
Instituto de Oncologia do Parana
Curitiba, ,
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Address
Instituto Nacional de Câncer - INCA
Rio de Janeiro, , 20231-050
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Address
Centro de Estudios Clínicos SAGA SpA
Santiago, , 7500653
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Address
Oncocentro APYS
Viña Del Mar, , 2520612
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Address
University Hospital Centre Zagreb
Zagreb, Grad Zagreb, 10 000
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Address
KBC "Sestre milosrdnice"
Zagreb, Grad Zagreb, 10000
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Address
CHU de Poitiers
Poitiers, Haute-Vienne, 21079
Status
Address
Hopital Ambroise Paré - Dermatologie
Boulogne Billancourt cedex, Hauts-de-Seine, 92104
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Address
ISR-GEO Med Res Clin Healthycore
Tbilisi, , 0112
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Address
LLC "Todua Clinic"
Tbilisi, , 0112
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Address
JSC KE Nat Ctr of Exp and Clin Surg
Tbilisi, , 0159
Status
Address
University Hospital Cologne AöR
Köln, Nordrhein-Westfalen, 50937
Status
Address
SRH Wald-Klinikum Gera gGmbH
Gera, Thüringen, 07548
Status
Address
Charité - Universitätsmedizin Berlin KöR
Berlin, , 10117
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Address
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
Meldola, Forli, 47014
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Address
Istituto dei Tumori "Giovanni Paolo II"
Bari, , 70124
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Address
ASST Papa Giovanni XXIII
Bergamo, , 24127
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Address
Ospedale San Raffaele, IRCCS
Milano, , 20132
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Address
Istituto Europeo di Oncologia IRCCS
Milano, , 20141
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Address
Azienda Ospedaliera Universitaria Federico II
Napoli, , 80131
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Address
Fondazione IRCCS Policlinico San Matteo
Pavia, , 27100
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Address
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
Roma, , 00167
Status
Address
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
Siena, , 53100
Status
Address
ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi
Varese, , 21100
Status
Address
Nagoya City University Hospital - Dermatology
Nagoya, Aiti [Aichi], 467-8601
Status
Address
Sapporo Medical University Hospital
Sapporo-Shi, Hokkaidô [Hokkaido], 060-8543
Status
Address
NHO Kagoshima Medical Center
Kagoshima-Shi, Kagosima [Kagoshima], 892-0853
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Address
Shizuoka Cancer Center - Dermatology
Koto-Ku, Tôkyô [Tokyo], 135-8550
Status
Address
Keio University Hospital - Dermatology
Shinjuku-ku, Tôkyô [Tokyo], 160-8582
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Address
Kumamoto University Hospital - Dermatology
Kumamoto, , 860-8556
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Address
Niigata Cancer Center Hospital
Niigata, , 951-8566
Status
Address
Osaka International Cancer Institute - Dermatological Oncology
Osaka-shi, Ôsaka [Osaka], 541-8567
Status
Address
Inje University Haeundae Paik Hospital
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48108
Status
Address
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722
Status
Address
Asan Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 05505
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Address
Samsung Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351
Status
Address
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
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Address
Hospital Pulau Pinang
Pulau Pinang, Pahang,
Status
Address
Hospital Umum Sarawak
Kuching, Sarawak, 93586
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Address
Hospital Umum Sarawak
Kuching, Sarawak,
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Address
Institut Kanser Negara
Putrajaya, Selangor, 62250
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Address
Hospital Canselor Tuanku Muhriz UKM
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000
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Address
Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan Kuala Lump,
Status
Address
Centro Inmuno Oncolog de Occidente
Guadalajara, Jalisco, 44630
Status
Address
I CAN ONCOLOGY CENTER SA de CV
Monterrey, Nuevo León, 64710
Status
Address
Ctro At Inv Cardio Potosi
San Luis Potosi, San Luis Potosí, 78200
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Address
Centro De Atenc E Inv Clín En Onco
Merida, Yucatán, 97134
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Address
Centro de Inv Medica Aguascalientes
Aguascalientes, , 20115
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Address
Oncare Viaducto Napoles
Mexico City, , 14080
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Address
Clinica Integral Internac Oncologia
Puebla, , 72530
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Address
Althian Research Management Center
San Pedro Garza Garcia, , 66278
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Address
Centro Medico Zambrano Hellion
San Pedro Garza García, , 66278
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Address
Clinical Research Institute S.C.
Tlalnepantla de Baz, ,
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Address
IMSP Institutul Oncologic, ARENSIA
Chisinau, , MD-2025
Status
Address
Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht
Breda, Noord-Brabant, 4818 CK
Status
Address
Arensia - Iocn
Cluj-Napoca, Cluj, 400015
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Address
Arensia - Iob
Bucuresti, , 022328
Status
Address
Vojvodina Institute for Oncology
Sremska Kamenica, Vojvodina, 21204
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Military Medical Academy
Belgrade, , 11000
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Address
Specialized hospital Oncomed System
Belgrade, , 11070
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Address
Institute for Oncology and Radiology of Serbia
Beograd, ,
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University Clinical Center Kragujevac
Kragujevac, , 34000
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Address
University Clinical Center Nis
Nis, , 18108
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Medical Oncology Cent of Rosebank
Johannesburg, Gauteng, 2196
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Address
Wits Clinical Research
Parktown, Johannesburg, Gauteng, 2193
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Address
Mary Potter Oncology Centre
Pretoria, Gauteng, 0181
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Rondebosch Oncology Centre
Cape Town, Western Cape, 7700
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Address
Cape Town Oncology Trials
Kraaifontein, Western Cape, 7570
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Address
Hospital Universitario Virgen De La Macarena
Sevilla, Andalucía, 41009
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Address
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
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Address
Hospital San Pedro de Alcántara
Caceres, Cáceres, 10003
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Address
M.D. Anderson Center Madrid
Madrid,, Madrid, 28033
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Address
H.U.V.Arrixaca
El Palmar, Murcia, Región De, 30120
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Address
Hospital de La Santa Creu i Sant Pau
Barcelona, , 08025
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Address
Hospital Universitari Vall D Hebron
Barcelona, , 08035
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Address
Hospital Clinic De Barcelona
Barcelona, , 08036
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Address
Consorcio Hospital General Universitario de Valencia
Valencia, , 46014
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Address
China Medical University Hospital - Internal Medicine
Taichung, Taichung Municipality, 40447
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Address
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
New Taipei City, Taipei, 23561
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Address
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University
Taipei, , 11696
Status
Address
Khon Kaen University, Srinagarind Hospital
Khonkaen, Khon Kaen, 40002
Status
Address
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, Krung Thep Maha Nakhon [Bangko, 10330
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Address
Siriraj Hospital
Bangkok, Krung Thep Maha Nakhon [Bangko, 10700
Status
Address
Prince of Songkla University - Faculty of Medicine
Songkhla, , 90110
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Address
Vietnam National Cancer Hopsital
Hanoi, Ha Noi, Thu Do, 100000
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Address
Hanoi Oncology Hospital
Hanoi, Ha Noi, Thu Do, 10000
Status
Address
HCM Oncology Hospital
Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go, 70000
