A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: ABP 206; Drug: Nivolumab

Detailed Description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

• Study Type: Interventional
• Enrollment (Estimated): 620
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Bosnia and Herzegovina
  • Mostar, Bosnia and Herzegovina, 88000
    • Recruiting
    • University Clinical Hospital Mostar
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Recruiting
    • Clinical Center University of Sarajevo
  • Tuzla, Bosnia and Herzegovina, 75000
    • Recruiting
    • University Clinical Center Tuzla
  • Zenica, Bosnia and Herzegovina, 72000
    • Recruiting
    • Cantonal Hospital Zenica
  • Republika Srpska
    • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
      • Recruiting
      • University Clinical Center of Republic of Srpska
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Recruiting
      • Dr. Everett Chalmers Hospital
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10 000
      • Recruiting
      • University hospital centre Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Recruiting
      • Poliklinika Anova
  • Osjecko-baranjska Županija
    • Osijek, Osjecko-baranjska Županija, Croatia, 31000
      • Recruiting
      • Klinicki bolnicki centar Osijek
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Recruiting
    • FN Hradec Kralove
  • Praha 2, Czechia, 128 08
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
• Estonia
  • Tallinn, Estonia
    • Recruiting
    • East Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Recruiting
    • Tartu University Hospital
• France
  • Haute-Vienne
    • Poitiers, Haute-Vienne, France, 21079
      • Recruiting
      • CHU de Poitiers
  • Nord
    • Lille, Nord, France, 59037
      • Recruiting
      • C.H.R.U Hopital Claude Huriez - Dermatologie
• Georgia
  • Tbilisi, Georgia, 0112
    • Recruiting
    • LLC "Todua Clinic"
  • Tbilisi, Georgia, 0112
    • Recruiting
    • ISR-GEO Med Res Clin Healthycore
  • Tbilisi, Georgia, 0159
    • Recruiting
    • JSC KE Nat Ctr of Exp and Clin Surg
  • Tbilisi, Georgia, 0186
    • Recruiting
    • Multprofil Clinic Consilium Medulla
• Italy
  • Firenze, Italy, 50134
    • Recruiting
    • AOU Careggi
  • Milano, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele, IRCCS
  • Milano, Italy, 20141
    • Recruiting
    • IEO - Istituto Europeo di Oncologia, IRCCS
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria Federico II
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00167
    • Recruiting
    • Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
  • Roma, Italy, 00144
    • Recruiting
    • IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
  • Siena, Italy, 53100
    • Recruiting
    • AOU Senese, Policlinico Le Scotte
  • Varese, Italy, 21100
    • Recruiting
    • Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi
  • Messina
    • Taormina, Messina, Italy, 98039
      • Recruiting
      • PO Ospedale San Vincenzo
• Lithuania
  • Vilnius, Lithuania, LT-08660
    • Recruiting
    • National Cancer Institute
• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Recruiting
      • Hospital Universiti Sains Malaysia
  • Pahang
    • Pulau Pinang, Pahang, Malaysia
      • Recruiting
      • Hospital Pulau Pinang
  • Sarawak
    • Kuching, Sarawak, Malaysia
      • Recruiting
      • Sarawak General Hospital
  • Selangor
    • Putrajaya, Selangor, Malaysia, 62250
      • Recruiting
      • Institut Kanser Negara
  • Wilayah Persekutuan Kuala Lump
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 56000
      • Recruiting
      • Hospital Canselor Tuanku Muhriz UKM
• Mexico
  • Guadalajara, Mexico
    • Recruiting
    • Boca Clinical Trials México
  • Mexico City, Mexico, 14080
    • Recruiting
    • ONCARE Viaducto Napoles
  • Puebla, Mexico, 72530
    • Recruiting
    • Clinica Integral Internac Oncologia
  • San Pedro Garza Garcia, Mexico, 66278
    • Recruiting
    • Althian Research Management Center
  • San Pedro Garza García, Mexico, 66278
    • Recruiting
    • Centro Medico Zambrano Hellion
  • Tlalnepantla de Baz, Mexico
    • Recruiting
    • Clinical Research Institute S.C.
  • Guanajuato
    • Leon, Guanajuato, Mexico, C. P. 37178
      • Recruiting
      • Preparaciones Oncologicas SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44630
      • Recruiting
      • Centro Inmuno Oncolog de Occidente
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Recruiting
      • I CAN ONCOLOGY CENTER SA de CV
  • Oaxaca
    • Juchitan, Oaxaca, Mexico, 70000
      • Recruiting
      • Cent de Estud y Prev del Cancer AC
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78200
      • Recruiting
      • Ctro At Inv Cardio Potosi
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Recruiting
      • Neurociencias Estudios Clínicos SC
  • Yucatán
    • Merida, Yucatán, Mexico, 97134
      • Recruiting
      • Centro De Atenc E Inv Clín En Onco
• Portugal
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz
  • Lisboa, Portugal
    • Recruiting
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil
  • Lisboa, Portugal, 1449-005
    • Recruiting
    • Hospital de São Francisco Xavier
• Romania
  • Cluj-Napoca, Romania, 400641
    • Recruiting
    • Medisprof
  • Iasi, Romania, 700106
    • Recruiting
    • Centrul de Oncologie Euroclinic
  • Sibiu, Romania, 550245
    • Recruiting
    • Spitalul Clinic Judetean De Urgenta Sibiu
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Recruiting
      • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
    • Floresti, Cluj, Romania, 407280
      • Recruiting
      • Radiotherapy Center Cluj
  • Dolj
    • Craiova, Dolj, Romania, 200746
      • Recruiting
      • Centrul de Oncologie Sf. Nectarie
  • Timis
    • Timisoara, Timis, Romania, 300166
      • Recruiting
      • Oncocenter-Oncologie Clinica
• Serbia
  • Vojvodina
    • Sremska Kamenica, Vojvodina, Serbia, 21204
      • Recruiting
      • Vojvodina Institute for Oncology
• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d Hebron
  • Málaga, Spain, 29011
    • Recruiting
    • Hospital Regional Universitario de Malaga
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Jerez Puerta Del Sur
  • Valencia, Spain, 46014
    • Recruiting
    • Consorcio Hospital General Universitario de Valencia
  • Andalucía
    • Sevilla, Andalucía, Spain, 41009
      • Recruiting
      • Hospital Universitario Virgen De La Macarena
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
  • Cáceres
    • Caceres, Cáceres, Spain, 10003
      • Recruiting
      • Hospital San Pedro de Alcántara
  • Madrid
    • Madrid,, Madrid, Spain, 28033
      • Recruiting
      • M.D. Anderson Center Madrid
  • Murcia, Región De
    • El Palmar, Murcia, Región De, Spain, 30120
      • Recruiting
      • H.U.V.Arrixaca
• Thailand
  • Songkhla, Thailand, 90110
    • Recruiting
    • Prince of Songkla University
  • Khon Kaen
    • Khonkaen, Khon Kaen, Thailand, 40002
      • Recruiting
      • Khon Kaen University, Srinagarind Hospital
  • Krung Thep Maha Nakhon [Bangko
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10330
      • Recruiting
      • King Chulalongkorn Memorial Hospital [Medical Oncology]
    • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Ft Wayne Med Oncology Hematology
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70805
      • Recruiting
      • Our Lady of the Lake Physician Grp MO
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center-Greenebaum Cancer Ctr
  • Missouri
    • Springfield, Missouri, United States, 65807-5287
      • Recruiting
      • Oncology Hematology Associates
  • New York
    • East Syracuse, New York, United States, 13057
      • Recruiting
      • Hematology-Oncology Associates-CNY

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• At least 18 years of age.
• Histologically confirmed unresectable or metastatic melanoma.
• Subject has no prior systemic treatment for advanced disease.
• Subject must have measurable disease according to RECIST (version 1.1).
• Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key Exclusion Criteria:

• Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
• Subject has active central nervous system (CNS) metastases not previously treated.
• Ocular melanoma.
• Subject has active or known immune-mediated disorders.
• Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
• Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of 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

2

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 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
Active Comparator: Nivolumab; Subjects will receive Dose A of Nivolumab via IV infusion.	Drug: Nivolumab; Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.; Other Names: OPDIVO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response by Week 49	Week 49
Objective response at Week 17	Week 17
Progression-free survival (PFS)	From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)	From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with treatment-emergent adverse events	Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events	Week 1 until Week 105
Number of subjects with treatment-emergent adverse events of interest	Week 1 until Week 105
Number of subjects with anti-drug antibodies	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Serum concentrations of ABP 206 and nivolumab (trough)	Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

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): November 2, 2023
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic melanoma; Unresectable melanoma; Treatment-naive
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: 20210031; 2023-503288-40 (EudraCT Number)

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