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

Last updated: November 26, 2024
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

3

Condition

Melanoma

Treatment

EU-authorized Nivolumab

FDA-licensed Nivolumab

ABP 206

Clinical Study ID

NCT05907122
20220083
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 biomarkeranalyses in order to be randomized

  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion

Exclusion Criteria:

  • Previous anti-cancer treatment

  • Known hypersensitivity to monoclonal antibodies or to any of the excipients of thestudy drug

  • Ocular or uveal melanoma or history of carcinomatosis meningitis

  • History of auto-immune disease

  • Subject has medical conditions requiring systemic immunosuppression with eithercorticosteroids or other immunosuppressive medications within 14 days of the firstdose of the investigational product

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 256
Treatment Group(s): 3
Primary Treatment: EU-authorized Nivolumab
Phase: 3
Study Start date:
July 26, 2023
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Clínica Viedma

    Viedma, Río Negro R8500ACE
    Argentina

    Site Not Available

  • Fundación CENIT

    Caba, 1125
    Argentina

    Site Not Available

  • CIMMDP

    Mar del Plata, 7600
    Argentina

    Site Not Available

  • Instituto de Oncologia de Rosario

    Rosario, 2000
    Argentina

    Site Not Available

  • ISIS Clinica Especializada

    Santa Fe, S3000FFU
    Argentina

    Site Not Available

  • University Clinical Centre of the Republic of Srpska - Gastroenterology

    Banjaluka, Republika Srpska 78000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Hospital Mostar

    Mostar, 88000
    Bosnia and Herzegovina

    Site Not Available

  • Clinical Center University of Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Tuzla

    Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

  • Cantonal hospital Zenica

    Zenica, 72000
    Bosnia and Herzegovina

    Site Not Available

  • Hospital Sao Rafael

    Salvador, Bahia
    Brazil

    Site Not Available

  • ATO Oncologia

    Fortaleza, Ceará 60140-025
    Brazil

    Active - Recruiting

  • Centro de Oncologia Leonardo da Vinci -ATO Oncologia

    Fortaleza, Ceará 60140-025
    Brazil

    Site Not Available

  • Hospital Sirio Libanes - Brasilia

    Brasilia, Distrito Federal 70200 730
    Brazil

    Site Not Available

  • Centro de Tratamento Oncologico

    Belém, Pará 66063-495
    Brazil

    Site Not Available

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • PUCRS - Hospital São Lucas

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • CEPON - Centro de Pesquisas Oncológicas

    Florianopolis, Santa Catarina 888034-000
    Brazil

    Site Not Available

  • CEPON-Centro de Pesquisas Oncológicas

    Florianopolis, Santa Catarina 888034-000
    Brazil

    Active - Recruiting

  • Hospital de Cancer de Barretos

    Barretos, São Paulo 14784 400
    Brazil

    Site Not Available

  • Hospital e Maternidade Brasil

    Sao Paulo, São Paulo CEP 04501-000
    Brazil

    Site Not Available

  • Fac Med de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • Instituto de Oncologia do Parana

    Curitiba,
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, 20231-050
    Brazil

    Site Not Available

  • Fac Med de Sao Jose do Rio Preto

    São Paulo,
    Brazil

    Site Not Available

  • Centro de Estudios Clínicos SAGA SpA

    Santiago, 7500653
    Chile

    Site Not Available

  • Oncocentro APYS

    Viña Del Mar, 2520612
    Chile

    Site Not Available

  • KBC "Sestre milosrdnice"

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

  • University Hospital Centre Zagreb

    Zagreb, Grad Zagreb 10 000
    Croatia

    Site Not Available

  • Hôpital F Mitterrand - Dermatology

    Dijon, Côte-d'Or 21000
    France

    Site Not Available

  • CHU de Bordeaux - Hopital Saint André

    Bordeaux, Gironde 33000
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, Haute-Vienne 21079
    France

    Site Not Available

  • Hopital Ambroise Paré - Dermatologie

    Boulogne Billancourt cedex, Hauts-de-Seine 92104
    France

    Site Not Available

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi, 0112
    Georgia

    Site Not Available

  • JSC KE Nat Ctr of Exp and Clin Surg

    Tbilisi, 0159
    Georgia

    Site Not Available

  • LLC "Todua Clinic"

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Goethe University Hospital

    Frankfurt/Main, Hessen 60590
    Germany

    Site Not Available

  • Goethe University Hospital Frankfurt

    Frankfurt/Main, Hessen 60590
    Germany

    Site Not Available

  • University Hospital Cologne AöR

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • SRH Wald-Klinikum Gera gGmbH

    Gera, Thüringen 07548
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, 10117
    Germany

    Site Not Available

  • Clínica Viedma

    IndiaHyderabadRemote, 00000
    India

    Site Not Available

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, Georgia 0112
    Israel

    Active - Recruiting

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L

    Meldola, Forli 47014
    Italy

    Site Not Available

  • Istituto dei Tumori "Giovanni Paolo II"

    Bari, 70124
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia IRCCS

    Milano, 20141
    Italy

    Site Not Available

  • Ospedale San Raffaele, IRCCS

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Istituto Dermopatico dell'Immacolata (IDI) - IRCCS

    Roma, 00167
    Italy

    Site Not Available

  • Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte

    Siena, 53100
    Italy

    Site Not Available

  • ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi

    Varese, 21100
    Italy

    Site Not Available

  • Nagoya City University Hospital - Dermatology

    Nagoya, Aiti [Aichi] 467-8601
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Sapporo-Shi, Hokkaidô [Hokkaido] 060-8543
    Japan

    Site Not Available

  • NHO Kagoshima Medical Center

    Kagoshima-Shi, Kagosima [Kagoshima] 892-0853
    Japan

    Site Not Available

  • Shizuoka Cancer Center - Dermatology

    Koto-Ku, Tôkyô [Tokyo] 135-8550
    Japan

    Site Not Available

  • Keio University Hospital - Dermatology

    Shinjuku-ku, Tôkyô [Tokyo] 160-8582
    Japan

    Site Not Available

  • Osaka International Cancer Institute - Dermatological Oncology

    Osaka-shi, Ôsaka [Osaka] 541-8567
    Japan

    Site Not Available

  • Kumamoto University Hospital - Dermatology

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Matsumoto-shi, 390-8621
    Japan

    Site Not Available

  • Niigata Cancer Center Hospital

    Niigata, 951-8566
    Japan

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, Busan Gwang'yeogsi [Pusan-Kwan 48108
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 03722
    Korea, Republic of

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan 16150
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Pulau Pinang, Pahang
    Malaysia

    Site Not Available

  • Hospital Umum Sarawak

    Kuching, Sarawak
    Malaysia

    Site Not Available

  • Institut Kanser Negara

    Putrajaya, Selangor 62250
    Malaysia

    Site Not Available

  • National Cancer Institute

    Putrajaya, Selangor 62250
    Malaysia

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz UKM

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump 56000
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump
    Malaysia

    Site Not Available

  • UKM Medical Centre

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump 56000
    Malaysia

    Active - Recruiting

  • Centro Inmuno Oncolog de Occidente

    Guadalajara, Jalisco 44630
    Mexico

    Site Not Available

  • I CAN ONCOLOGY CENTER SA de CV

    Monterrey, Nuevo León 64710
    Mexico

    Site Not Available

  • Ctro At Inv Cardio Potosi

    San Luis Potosi, San Luis Potosí 78200
    Mexico

    Site Not Available

  • Centro De Atenc E Inv Clín En Onco

    Merida, Yucatán 97134
    Mexico

    Site Not Available

  • Centro de Inv Medica Aguascalientes

    Aguascalientes, 20115
    Mexico

    Site Not Available

  • Oncare Viaducto Napoles

    Mexico City, 14080
    Mexico

    Site Not Available

  • Clinica Integral Internac Oncologia

    Puebla, 72530
    Mexico

    Site Not Available

  • Althian Research Management Center

    San Pedro Garza Garcia, 66278
    Mexico

    Site Not Available

  • Centro Medico Zambrano Hellion

    San Pedro Garza García, 66278
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla de Baz,
    Mexico

    Site Not Available

  • IMSP Institutul Oncologic, ARENSIA

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht

    Breda, Noord-Brabant 4818 CK
    Netherlands

    Site Not Available

  • Amphia Ziekenhuis - Molengracht

    Breda, Noord-Brabant 4818 CK
    Netherlands

    Active - Recruiting

  • Arensia - Iocn

    Cluj-Napoca, Cluj 400015
    Romania

    Site Not Available

  • Arensia - Iob

    Bucuresti, 022328
    Romania

    Site Not Available

  • Vojvodina Institute for Oncology

    Sremska Kamenica, Vojvodina 21204
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • Specialized hospital Oncomed System

    Belgrade, 11070
    Serbia

    Site Not Available

  • Institute for Oncology and Radiology of Serbia

    Beograd,
    Serbia

    Site Not Available

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • University Clinical Center Nis

    Nis, 18108
    Serbia

    Site Not Available

  • Medical Oncology Cent of Rosebank

    Johannesburg, Gauteng 2196
    South Africa

    Site Not Available

  • Wits Clinical Research

    Parktown, Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Mary Potter Oncology Centre

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Rondebosch Oncology Centre

    Cape Town, Western Cape 7700
    South Africa

    Site Not Available

  • Cape Town Oncology Trials

    Kraaifontein, Western Cape 7570
    South Africa

    Site Not Available

  • GVI Oncology,CapeGate Oncology Cent

    Kraaifontein, Western Cape 7570
    South Africa

    Active - Recruiting

  • Hospital Universitario Virgen De La Macarena

    Sevilla, Andalucía 41009
    Spain

    Site Not Available

  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital San Pedro de Alcántara

    Caceres, Cáceres 10003
    Spain

    Site Not Available

  • M.D. Anderson Center Madrid

    Madrid,, Madrid 28033
    Spain

    Site Not Available

  • H.U.V.Arrixaca

    El Palmar, Murcia, Región De 30120
    Spain

    Site Not Available

  • Hospital Clinic De Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Jerez Puerta Del Sur

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • China Medical University Hospital - Internal Medicine

    Taichung, Taichung Municipality 40447
    Taiwan

    Site Not Available

  • Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare

    New Taipei City, Taipei 23561
    Taiwan

    Site Not Available

  • Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University

    Taipei, 11696
    Taiwan

    Site Not Available

  • Khon Kaen University, Srinagarind Hospital

    Khonkaen, Khon Kaen 40002
    Thailand

    Site Not Available

  • King Chulalongkorn Memorial Hospital [Medical Oncology]

    Bangkok, Krung Thep Maha Nakhon [Bangko 10330
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok, Krung Thep Maha Nakhon [Bangko 10700
    Thailand

    Site Not Available

  • Prince of Songkla University - Faculty of Medicine

    Songkhla, 90110
    Thailand

    Site Not Available

  • Cancer and Blood Specialty Clinic

    Long Beach, California 90806
    United States

    Site Not Available

  • The Lundquist Institute - Main

    Torrance, California 90502-2004
    United States

    Site Not Available

  • AdventHealth

    Orlando, Florida 32804
    United States

    Site Not Available

  • University of Maryland Medical Center-Greenebaum Cancer Ctr

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Crt

    Billings, Montana 59102-6746
    United States

    Site Not Available

  • Hanoi Oncology Hospital

    Hanoi, Ha Noi, Thu Do 10000
    Vietnam

    Site Not Available

  • Vietnam National Cancer Hopsital

    Hanoi, Ha Noi, Thu Do 100000
    Vietnam

    Site Not Available

  • HCM Oncology Hospital

    Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go 70000
    Vietnam

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.