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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: ABP 206; Drug: FDA-licensed Nivolumab; Drug: EU-authorized Nivolumab

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Río Negro Province
    • Mar Del Plata, Río Negro Province, Argentina, 7600
      • Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
• Bosnia and Herzegovina
  • Mostar, Bosnia and Herzegovina, 88000
    • University Clinical Hospital Mostar - Clinic for Lung Diseases
  • Kanton Sarajevo
    • Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000
      • Clinical Center University of Sarajevo - Clinic of Oncology
  • Republika Srpska
    • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
      • University Clinical Centre of the Republic of Srpska - Gastroenterology
  • Tuzlanski Kanton
    • Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina, 75000
      • University Clinical Center Tuzla - Oncology, Hematology and Radio
  • Zeničko-dobojski Kanton
    • Zenica, Zeničko-dobojski Kanton, Bosnia and Herzegovina, 72000
      • Cantonal hospital Zenica - Oncology
• Brazil
  • São Paulo, Brazil, 15090-000
    • Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology
  • Ceará
    • Fortaleza, Ceará, Brazil, 60140-025
      • ATO Oncologia
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41256900
      • Hospital Sao Rafael
  • Federal District
    • Brasília, Federal District, Brazil, 70200 730
      • Hospital Sirio Libanes - Brasilia - Oncology
  • Paraná
    • Curitiba, Paraná, Brazil, 80040170
      • Instituto de Oncologia do Parana
  • Pará
    • Belém, Pará, Brazil, 66063-495
      • CTO Centro de Tratamento Oncologico LTDA
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 888034-000
      • CEPON - Centro de Pesquisas Oncologicas
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784 400
      • Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
• Chile
  • Región de Valparaíso
    • Valparaíso, Región de Valparaíso, Chile, 2363058
      • Oncocentro Apys
• Croatia
  • City of Zagreb
    • Grad Zagreb, City of Zagreb, Croatia, 10000
      • Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics
    • Zagreb, City of Zagreb, Croatia, 10 000
      • University Hospital Centre Zagreb - Oncology department
• Georgia
  • Tbilisi, Georgia, 0112
    • LTD "Israel-Georgian Medical Research Clinic Healthycore"
  • Tbilisi, Georgia, 0159
    • JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
• Italy
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Roma, Italy, 00167
    • Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
  • Siena, Italy, 53100
    • Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncolo
  • Forli
    • Meldola, Forli, Italy, 47014
      • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
• Japan
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital - Dermatology
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital - Dermatology
  • Aiti [Aichi]
    • Nagoya, Aiti [Aichi], Japan, 467-8601
      • Nagoya City University Hospital - Dermatology
  • Hokkaidô [Hokkaido]
    • Sapporo, Hokkaidô [Hokkaido], Japan, 060-8543
      • Sapporo Medical University Hospital
  • Kagosima [Kagoshima]
    • Kagoshima, Kagosima [Kagoshima], Japan, 892-0853
      • National Hospital Organization Kagoshima Medical Center - Haematology
  • Tôkyô [Tokyo]
    • Kōtoku, Tôkyô [Tokyo], Japan, 135-8550
      • Shizuoka Cancer Center - Dermatology
    • Shinjuku-ku, Tôkyô [Tokyo], Japan, 160-8582
      • Keio University Hospital - Dermatology
  • Ôsaka [Osaka]
    • Osaka, Ôsaka [Osaka], Japan, 541-8567
      • Osaka International Cancer Institute - Dermatological Oncology
• Lithuania
  • Vilnius County
    • Vilnius, Vilnius County, Lithuania, LT-08660
      • National Cancer Institute - Conservative Tumour Therapy
• Malaysia
  • Pahang
    • Pulau Pinang, Pahang, Malaysia, 00000
      • Hospital Pulau Pinang - Rheumatology
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Hospital Umum Sarawak
  • Selangor
    • Putrajaya, Selangor, Malaysia, 62250
      • National Cancer Institute - Radiotherapy and Oncology
  • Terengganu
    • Kubang Kerian, Terengganu, Malaysia, 16150
      • Hospital Universiti Sains Malaysia
  • Wilayah Persekutuan Kuala Lump
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz UKM
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 00000
      • Hospital Kuala Lumpur - Surgery
• Mexico
  • Puebla City, Mexico, 72530
    • ONCOCENTER PUEBLA - Dermatology
  • Tlalnepantla, Mexico, 54055
    • Clinical Research Institute
  • Jalisco
    • Guadalajra, Jalisco, Mexico, 44630
      • Centro de Inm Onc de Occ Sa de Cv
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • Althian - Research Management Center
  • San Luis Potosí
    • San Luis Potosí City, San Luis Potosí, Mexico, 78200
      • Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
• Moldova
  • Moldova, Republic of
    • Chisinau, Moldova, Republic of, Moldova, MD-2025
      • Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
• Netherlands
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818 CK
      • Amphia Hospital - unspecified
• Romania
  • Bucharest, Romania, 022328
    • Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia, Department for Lung Cancer
  • Nišavski Okrug
    • Niš, Nišavski Okrug, Serbia, 18108
      • University Clinical Center of Nis, Clinic for Oncology
  • Šumadijski Okrug
    • Kragujevac, Šumadijski Okrug, Serbia, 34000
      • University Clinical Center of Kragujevac, Center for Internal Oncology
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • The Medical Oncology Centre of Rosebank
    • Parktown, Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7700
      • Cancercare - Rondebosch Oncology
    • Cape Town, Western Cape, South Africa, 7570
      • Cape Gate Oncology Centre
• South Korea
  • Busan Gwang'yeogsi [Pusan-Kwan
    • Busan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea, 48108
      • Inje University Haeundae Paik Hospital - Oncology
  • Gyeonggido [Kyonggi-do]
    • Suwon, Gyeonggido [Kyonggi-do], South Korea, 16247
      • The Catholic University of Korea, St. Vincent'S Hospital
  • Seoul Teugbyeolsi [Seoul-T'ukp
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 03722
      • Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 05505
      • Asan Medical Center - Oncology
    • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea, 06351
      • Samsung Medical Center - Family Medicine
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau - Oncología Médica
  • Seville, Spain, 41009
    • Hospital HLA Jerez Puerta Sur
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia - Oncología
  • Cáceres
    • Cáceres, Cáceres, Spain, 10003
      • Hospital San Pedro de Alcántara - Oncología
  • Murcia, Región de
    • El Palmar, Murcia, Región de, Spain, 30120
      • H.U.V.Arrixaca - Oncología
• Taiwan
  • Taichung Municipality
    • Taichung, Taichung Municipality, Taiwan, 40447
      • China Medical University Hospital - Internal Medicine
  • Taipei
    • New Taipei City, Taipei, Taiwan, 23561
      • Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
• Thailand
  • Changwat Khon Kaen
    • Khonkaen, Changwat Khon Kaen, Thailand, 40002
      • Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
  • Changwat Songkhla
    • Songkhla, Changwat Songkhla, Thailand, 90110
      • Prince of Songkla University
  • Krung Thep Maha Nakhon [Bangko
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10330
      • King Chulalongkorn Memorial Hospital [Medical Oncology]
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10700
      • Siriraj Hospital - Medical Oncology
• United States
  • California
    • Long Beach, California, United States, 90806
      • Cancer and Blood Specialty Clinic
  • Montana
    • Billings, Montana, United States, 59102-6746
      • St. Vincent Frontier Cancer Center - Oncology
• Vietnam
  • Ha Noi, Thu Do
    • Hanoi, Ha Noi, Thu Do, Vietnam, 100000
      • Vietnam National Cancer Hopsital
  • Ho Chi Minh, Thanh Pho [Sai Go
    • Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam, 70000
      • HCM Oncology Hospital - Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP 206; Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.	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.
Active Comparator: FDA-licensed Nivolumab; Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.	Drug: FDA-licensed Nivolumab; FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.; Other Names: OPDIVO®
Active Comparator: EU-authorized Nivolumab; Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.	Drug: EU-authorized Nivolumab; FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.; Other Names: OPDIVO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)	The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.	Day 1 (Postdose) through Day 28
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)	The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.	Week 17 through Week 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentrations at Predose (Ctrough)	The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Serious Adverse Events	The safety (treatment-emergent serious adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Adverse Events	The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-emergent Adverse Events-of-interest	The safety (treatment-emergent adverse events-of-interest) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in adjuvant setting.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Recurrence-free Survival (RFS)	The RFS is assessed to compare the efficacy of ABP 206 with nivolumab in subjects with advanced melanoma in the adjuvant setting. The RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional, distant metastasis) or death (whatever the cause), or date of last visit/contact with disease assessments (for subjects who remain alive and whose disease has not recurred).	Randomization through 12 months (or until RFS criteria is met)
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)	The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Maximum Observed Serum Concentration at Steady State (Cmax_ss)	The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Number of Subjects With Anti-drug Antibodies (ADAs)	The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.	Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
Time to reach Cmax following the first dose (Tmax_dose 1)	The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Time to reach Cmax at steady state (Tmax_ss)	The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations (Ctrough)	The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Melanoma; Pharmacokinetic similarity study; Adjuvant melanoma treatment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab
• Other Study ID Numbers: 20220083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No