Spots Global Cancer Trial Database for A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
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Trial Identification
Brief Title: A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Official Title: 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
Study ID: NCT05907122
Conditions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer and Blood Specialty Clinic, Long Beach, California, United States
The Lundquist Institute - Main, Torrance, California, United States
AdventHealth, Orlando, Florida, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr, Baltimore, Maryland, United States
St. Vincent Frontier Cancer Crt, Billings, Montana, United States
Clínica Viedma, Viedma, Río Negro, Argentina
Fundación CENIT, Caba, , Argentina
CIMMDP, Mar del Plata, , Argentina
Instituto de Oncologia de Rosario, Rosario, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
University Clinical Centre of the Republic of Srpska - Gastroenterology, Banjaluka, Republika Srpska, Bosnia and Herzegovina
University Clinical Hospital Mostar, Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo, Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla, Tuzla, , Bosnia and Herzegovina
Cantonal hospital Zenica, Zenica, , Bosnia and Herzegovina
Hospital Sao Rafael, Salvador, Bahia, Brazil
Centro de Oncologia Leonardo da Vinci -ATO Oncologia, Fortaleza, Ceará, Brazil
Hospital Sirio Libanes - Brasilia, Brasilia, Distrito Federal, Brazil
Centro de Tratamento Oncologico, Belém, Pará, Brazil
PUCRS - Hospital São Lucas, Porto Alegre, Rio Grande Do Sul, Brazil
CEPON-Centro de Pesquisas Oncológicas, Florianopolis, Santa Catarina, Brazil
Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil
Hospital e Maternidade Brasil, Sao Paulo, São Paulo, Brazil
Fac Med de Sao Jose do Rio Preto, São José do Rio Preto, São Paulo, Brazil
Instituto de Oncologia do Parana, Curitiba, , Brazil
Centro de Estudios Clínicos SAGA SpA, Santiago, , Chile
Oncocentro APYS, Viña Del Mar, , Chile
University Hospital Centre Zagreb, Zagreb, Grad Zagreb, Croatia
KBC "Sestre milosrdnice", Zagreb, Grad Zagreb, Croatia
Hôpital F Mitterrand - Dermatology, Dijon, Côte-d'Or, France
CHU de Bordeaux - Hopital Saint André, Bordeaux, Gironde, France
CHU de Poitiers, Poitiers, Haute-Vienne, France
Hopital Ambroise Paré - Dermatologie, Boulogne Billancourt cedex, Hauts-de-Seine, France
ISR-GEO Med Res Clin Healthycore, Tbilisi, , Georgia
LLC "Todua Clinic", Tbilisi, , Georgia
JSC KE Nat Ctr of Exp and Clin Surg, Tbilisi, , Georgia
Goethe University Hospital, Frankfurt/Main, Hessen, Germany
University Hospital Cologne AöR, Köln, Nordrhein-Westfalen, Germany
SRH Wald-Klinikum Gera gGmbH, Gera, Thüringen, Germany
Charité - Universitätsmedizin Berlin KöR, Berlin, , Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L, Meldola, Forli, Italy
Istituto dei Tumori "Giovanni Paolo II", Bari, , Italy
ASST Papa Giovanni XXIII, Bergamo, , Italy
Ospedale San Raffaele, IRCCS, Milano, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS, Roma, , Italy
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte, Siena, , Italy
ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi, Varese, , Italy
Nagoya City University Hospital - Dermatology, Nagoya, Aiti [Aichi], Japan
Sapporo Medical University Hospital, Sapporo-Shi, Hokkaidô [Hokkaido], Japan
NHO Kagoshima Medical Center, Kagoshima-Shi, Kagosima [Kagoshima], Japan
Shizuoka Cancer Center - Dermatology, Koto-Ku, Tôkyô [Tokyo], Japan
Keio University Hospital - Dermatology, Shinjuku-ku, Tôkyô [Tokyo], Japan
Kumamoto University Hospital - Dermatology, Kumamoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute - Dermatological Oncology, Osaka-shi, Ôsaka [Osaka], Japan
Inje University Haeundae Paik Hospital, Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Asan Medical Center, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang, Pulau Pinang, Pahang, Malaysia
Hospital Umum Sarawak, Kuching, Sarawak, Malaysia
Institut Kanser Negara, Putrajaya, Selangor, Malaysia
Hospital Canselor Tuanku Muhriz UKM, Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Centro Inmuno Oncolog de Occidente, Guadalajara, Jalisco, Mexico
I CAN ONCOLOGY CENTER SA de CV, Monterrey, Nuevo León, Mexico
Ctro At Inv Cardio Potosi, San Luis Potosi, San Luis Potosí, Mexico
Centro De Atenc E Inv Clín En Onco, Merida, Yucatán, Mexico
Centro de Inv Medica Aguascalientes, Aguascalientes, , Mexico
Oncare Viaducto Napoles, Mexico City, , Mexico
Clinica Integral Internac Oncologia, Puebla, , Mexico
Althian Research Management Center, San Pedro Garza Garcia, , Mexico
Centro Medico Zambrano Hellion, San Pedro Garza García, , Mexico
Clinical Research Institute S.C., Tlalnepantla de Baz, , Mexico
Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht, Breda, Noord-Brabant, Netherlands
Arensia - Iocn, Cluj-Napoca, Cluj, Romania
Arensia - Iob, Bucuresti, , Romania
Vojvodina Institute for Oncology, Sremska Kamenica, Vojvodina, Serbia
Specialized hospital Oncomed System, Belgrade, , Serbia
Institute for Oncology and Radiology of Serbia, Beograd, , Serbia
University Clinical Center Kragujevac, Kragujevac, , Serbia
University Clinical Center Nis, Nis, , Serbia
Medical Oncology Cent of Rosebank, Johannesburg, Gauteng, South Africa
Wits Clinical Research, Parktown, Johannesburg, Gauteng, South Africa
Mary Potter Oncology Centre, Pretoria, Gauteng, South Africa
Rondebosch Oncology Centre, Cape Town, Western Cape, South Africa
Cape Town Oncology Trials, Kraaifontein, Western Cape, South Africa
Hospital Universitario Virgen De La Macarena, Sevilla, Andalucía, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital San Pedro de Alcántara, Caceres, Cáceres, Spain
M.D. Anderson Center Madrid, Madrid,, Madrid, Spain
H.U.V.Arrixaca, El Palmar, Murcia, Región De, Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall D Hebron, Barcelona, , Spain
Hospital Clinic De Barcelona, Barcelona, , Spain
Hospital Jerez Puerta Del Sur, Sevilla, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
China Medical University Hospital - Internal Medicine, Taichung, Taichung Municipality, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare, New Taipei City, Taipei, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University, Taipei, , Taiwan
Khon Kaen University, Srinagarind Hospital, Khonkaen, Khon Kaen, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology], Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Siriraj Hospital, Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Prince of Songkla University - Faculty of Medicine, Songkhla, , Thailand
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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