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

NCT05907122 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 20220083
• Study Type: interventional
• Target: 256
• Locations: 22 countries
• Sites: 76

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.

Conditions

Melanoma

Keywords

Pharmacokinetic similarity study; Adjuvant melanoma treatment; Advanced Melanoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)

  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)

  Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)

• Serum Concentrations at Predose (Ctrough)

  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

  Week 1 (First dose of study drug) through Week 53 (End of Study)

• Number of Subjects With Treatment-Emergent Adverse Events

  Week 1 (First dose of study drug) through Week 53 (End of Study)

Study Arms (3)

ABP 206

EXPERIMENTAL

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Drug: ABP 206

FDA-licensed Nivolumab

ACTIVE COMPARATOR

Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.

Drug: FDA-licensed Nivolumab

EU-authorized Nivolumab

ACTIVE COMPARATOR

Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.

Drug: EU-authorized Nivolumab

Interventions

ABP 206 DRUG

ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.

ABP 206

FDA-licensed Nivolumab DRUG

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Also known as: OPDIVO®

FDA-licensed Nivolumab

EU-authorized Nivolumab DRUG

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Also known as: OPDIVO®

EU-authorized Nivolumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (76)

Cancer and Blood Specialty clinic

Long Beach, California, 90806, United States

Location

St. Vincent Frontier Cancer Center - Oncology

Billings, Montana, 59102-6746, United States

Location

Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology

Mar Del Plata, Río Negro Province, 7600, Argentina

Location

Clinical Center University of Sarajevo - Clinic of Oncology

Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Centre of the Republic of Srpska - Gastroenterology

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla - Oncology, Hematology and Radio

Tuzla, Tuzlanski Kanton, 75000, Bosnia and Herzegovina

Location

Cantonal hospital Zenica - Oncology

Zenica, Zeničko-dobojski Kanton, 72000, Bosnia and Herzegovina

Location

University Clinical Hospital Mostar - Clinic for Lung Diseases

Mostar, 88000, Bosnia and Herzegovina

Location

ATO Oncologia

Fortaleza, Ceará, 60140-025, Brazil

Location

Hospital Sao Rafael

Salvador, Estado de Bahia, 41256900, Brazil

Location

Hospital Sirio Libanes - Brasilia - Oncology

Brasília, Federal District, 70200 730, Brazil

Location

Instituto de Oncologia do Parana

Curitiba, Paraná, 80040170, Brazil

Location

Cto Centro de Tratamento Oncologico Ltda

Belém, Pará, 66063-495, Brazil

Location

PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

CEPON - Centro de Pesquisas Oncológicas

Florianópolis, Santa Catarina, 888034-000, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor

Barretos, São Paulo, 14784 400, Brazil

Location

Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology

São Paulo, 15090-000, Brazil

Location

Oncocentro Apys

Valparaíso, Región de Valparaíso, 2363058, Chile

Location

Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics

Grad Zagreb, City of Zagreb, 10000, Croatia

Location

University Hospital Centre Zagreb - Oncology department

Zagreb, City of Zagreb, 10 000, Croatia

Location

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, 0112, Georgia

Location

JSC "K.Eristavi National Center of Experimental and Clinical Surgery"

Tbilisi, 0159, Georgia

Location

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

Meldola, Forli, 47014, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia

Roma, 00167, Italy

Location

Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncolo

Siena, 53100, Italy

Location

Nagoya City University Hospital - Dermatology

Nagoya, Aiti [Aichi], 467-8601, Japan

Location

Sapporo Medical University Hospital

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

Location

National Hospital Organization Kagoshima Medical Center - Haematology

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

Location

Shizuoka Cancer Center - Dermatology

Kōtoku, Tôkyô [Tokyo], 135-8550, Japan

Location

Keio University Hospital - Dermatology

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

Location

Kumamoto University Hospital - Dermatology

Kumamoto, 860-8556, Japan

Location

Niigata Cancer Center Hospital - Dermatology

Niigata, 951-8566, Japan

Location

Osaka International Cancer Institute - Dermatological Oncology

Osaka, Ôsaka [Osaka], 541-8567, Japan

Location

National Cancer Institute - Conservative Tumour Therapy

Vilnius, Vilnius County, LT-08660, Lithuania

Location

Hospital Pulau Pinang - Rheumatology

Pulau Pinang, Pahang, 00000, Malaysia

Location

Hospital Umum Sarawak

Kuching, Sarawak, 93586, Malaysia

Location

National Cancer Institute - Radiotherapy and Oncology

Putrajaya, Selangor, 62250, Malaysia

Location

Hospital Universiti Sains Malaysia

Kubang Kerian, Terengganu, 16150, Malaysia

Location

Hospital Kuala Lumpur - Surgery

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 00000, Malaysia

Location

Hospital Canselor Tuanku Muhriz UKM

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000, Malaysia

Location

Centro de Inm Onc de Occ Sa de Cv

Guadalajra, Jalisco, 44630, Mexico

Location

Althian - Research Management Center

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Hospital Angeles Centro Médico San Luis Potosí - Cardiologia

San Luis Potosí City, San Luis Potosí, 78200, Mexico

Location

ONCOCENTER PUEBLA - Dermatology

Puebla City, 72530, Mexico

Location

Clinical Research Institute

Tlalnepantla, 54055, Mexico

Location

Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology

Chisinau, Moldova, Republic of, MD-2025, Moldova

Location

Amphia Hospital - unspecified

Breda, North Brabant, 4818 CK, Netherlands

Location

Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On

Cluj-Napoca, Cluj, 400015, Romania

Location

Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures

Bucharest, 022328, Romania

Location

University Clinical Center of Nis, Clinic for Oncology

Niš, Nišavski Okrug, 18108, Serbia

Location

Institute for Oncology and Radiology of Serbia, Department for Lung Cancer

Belgrade, 11000, Serbia

Location

University Clinical Center of Kragujevac, Center for Internal Oncology

Kragujevac, Šumadijski Okrug, 34000, Serbia

Location

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, 2196, South Africa

Location

Wits Clinical Research

Parktown, Johannesburg, Gauteng, 2193, South Africa

Location

Mary Potter Oncology Centre

Pretoria, Gauteng, 0181, South Africa

Location

Cape Gate Oncology Centre

Cape Town, Western Cape, 7570, South Africa

Location

Cancercare - Rondebosch Oncology

Cape Town, Western Cape, 7700, South Africa

Location

Inje University Haeundae Paik Hospital - Oncology

Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48108, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido [Kyonggi-do], 16247, South Korea

Location

Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722, South Korea

Location

Asan Medical Center - Oncology

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 05505, South Korea

Location

Samsung Medical Center - Family Medicine

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351, South Korea

Location

Hospital San Pedro de Alcántara - Oncología

Cáceres, Cáceres, 10003, Spain

Location

H.U.V.Arrixaca - Oncología

El Palmar, Murcia, Región de, 30120, Spain

Location

Hospital de la Santa Creu i Sant Pau - Oncología Médica

Barcelona, 08041, Spain

Location

Hospital HLA Jerez Puerta Sur

Seville, 41009, Spain

Location

Consorcio Hospital General Universitario de Valencia - Oncología

Valencia, 46014, Spain

Location

China Medical University Hospital - Internal Medicine

Taichung, Taichung Municipality, 40447, Taiwan

Location

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

New Taipei City, Taipei, 23561, Taiwan

Location

Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)

Khonkaen, Changwat Khon Kaen, 40002, Thailand

Location

Prince of Songkla University

Songkhla, Changwat Songkhla, 90110, Thailand

Location

King Chulalongkorn Memorial Hospital [Medical Oncology]

Bangkok, Krung Thep Maha Nakhon [Bangko, 10330, Thailand

Location

Siriraj Hospital - Medical Oncology

Bangkok, Krung Thep Maha Nakhon [Bangko, 10700, Thailand

Location

Vietnam National Cancer Hopsital

Hanoi, Ha Noi, Thu Do, 100000, Vietnam

Location

HCM Oncology Hospital - Medical Oncology

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

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff), and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 26, 2023
• Primary Completion: March 26, 2025
• Study Completion: October 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

VN (2); TH (4); BO (5); AR (1); BR (9); IT (4); CL (1); CR (2); JP (8); GE (2); MY (6); ZA (5); KR (5); ES (5); LI (1); SE (3); ME (5); MO (1); NL (1); US (2); RO (2); TW (2)