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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054555
Other study ID # 20210031
Secondary ID 2023-503288-40
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 2, 2023
Est. completion date January 25, 2027

Study information

Verified date June 2024
Source Amgen
Contact Amgen Call Center
Phone 1-800-772-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 620
Est. completion date January 25, 2027
Est. primary completion date January 25, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). - Tumor tissue from site of unresectable or metastatic melanoma 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 Design


Related Conditions & MeSH terms


Intervention

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.
Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Locations

Country Name City State
Bosnia and Herzegovina University Clinical Center of Republic of Srpska Banja Luka 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
Canada Dr. Everett Chalmers Hospital Fredericton New Brunswick
Chile Oncocentro APYS Viña Del Mar
Croatia Klinicki bolnicki centar Osijek Osijek Osjecko-baranjska Županija
Croatia Poliklinika Anova Zagreb Grad Zagreb
Croatia University Hospital Centre Zagreb Zagreb Grad Zagreb
Czechia FN Hradec Kralove Hradec Kralove
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Estonia East Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
France C.H.R.U Hopital Claude Huriez - Dermatologie Lille Nord
France CHU de Poitiers Poitiers Haute-Vienne
Georgia ISR-GEO Med Res Clin Healthycore Tbilisi
Georgia JSC KE Nat Ctr of Exp and Clin Surg Tbilisi
Georgia LLC "Todua Clinic" Tbilisi
Georgia Multprofil Clinic Consilium Medulla Tbilisi
Germany Goethe University Hospital Frankfurt/Main Hessen
Germany University Hospital Cologne AöR Köln Nordrhein-Westfalen
Italy Istituto dei Tumori "Giovanni Paolo II" Bari
Italy ASST Papa Giovanni XXIII Bergamo
Italy AOU Careggi Firenze
Italy IEO - Istituto Europeo di Oncologia, IRCCS Milano
Italy Ospedale San Raffaele, IRCCS Milano
Italy Azienda Ospedaliera Universitaria Federico II Napoli
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE) Roma
Italy Istituto Dermopatico dell'Immacolata (IDI) - IRCCS Roma
Italy AOU Senese, Policlinico Le Scotte Siena
Italy PO Ospedale San Vincenzo Taormina Messina
Italy Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi Varese
Lithuania National Cancer Institute Vilnius
Malaysia Hospital Canselor Tuanku Muhriz UKM Kuala Lumpur Wilayah Persekutuan Kuala Lump
Malaysia Hospital Kuala Lumpur Kuala Lumpur Wilayah Persekutuan Kuala Lump
Malaysia Pantai Hospital Kuala Lumpur Kuala Lumpur Wilayah Persekutuan Kuala Lump
Malaysia Hospital Universiti Sains Malaysia Kubang Kerian Kelantan
Malaysia Sarawak General Hospital Kuching Sarawak
Malaysia Hospital Pulau Pinang Pulau Pinang Pahang
Malaysia Institut Kanser Negara Putrajaya Selangor
Mexico Centro de Inv Medica Aguascalientes Aguascalientes
Mexico Neurociencias Estudios Clínicos SC Culiacan Sinaloa
Mexico Boca Clinical Trials México Guadalajara
Mexico Centro Inmuno Oncolog de Occidente Guadalajara Jalisco
Mexico Cent de Estud y Prev del Cancer AC Juchitan Oaxaca
Mexico Preparaciones Oncologicas SC Leon Guanajuato
Mexico Centro De Atenc E Inv Clín En Onco Merida Yucatán
Mexico Oncare Viaducto Napoles Mexico City
Mexico I CAN ONCOLOGY CENTER SA de CV Monterrey Nuevo León
Mexico Clinica Integral Internac Oncologia Puebla
Mexico Ctro At Inv Cardio Potosi San Luis Potosi San Luis Potosí
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
Philippines Baguio General Hospital and Medical Center Baguio City Benguet
Philippines Cebu Doctors' University Hospital Cebu City
Philippines Center for Skin Research Testing Makati City National Capital Region
Philippines Cardinal Santos Madical Center San Juan City National Capital Region
Portugal Champalimaud Foundation - Champalimaud Centre for the Unknown (Champalimaud Cancer Center) Lisboa
Portugal Hospital da Luz Lisboa
Portugal Hospital de São Francisco Xavier Lisboa
Portugal Instituto Portugues de Oncologia de Lisboa Francisco Gentil Lisboa
Portugal Unidade Local de Saúde da Arrábida, E. P. E. Setubal Setúbal
Romania Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca Cluj-Napoca Cluj
Romania Medisprof Cluj-Napoca
Romania Centrul de Oncologie Sf. Nectarie Craiova Dolj
Romania Oncolab Craiova Dolj
Romania Radiotherapy Center Cluj Floresti Cluj
Romania Centrul de Oncologie Euroclinic Iasi
Romania Spitalul Clinic Judetean De Urgenta Sibiu Sibiu
Romania Oncocenter-Oncologie Clinica Timisoara Timis
Serbia University Clinical Center Kragujevac Kragujevac
Serbia Vojvodina Institute for Oncology Sremska Kamenica Vojvodina
Spain Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital de La Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Vall D Hebron Barcelona
Spain Hospital San Pedro de Alcántara Caceres Cáceres
Spain H.U.V.Arrixaca El Palmar Murcia, Región De
Spain M.D. Anderson Center Madrid Madrid, Madrid
Spain Hospital Regional Universitario de Malaga Málaga
Spain Hospital Jerez Puerta Del Sur Sevilla
Spain Hospital Universitario Virgen De La Macarena Sevilla Andalucía
Spain Consorcio Hospital General Universitario de Valencia Valencia
Taiwan Changhua Christian Medical Foundation Changhua Christian Hospital Changhua
Thailand King Chulalongkorn Memorial Hospital [Medical Oncology] Bangkok Krung Thep Maha Nakhon [Bangko
Thailand Ramathibodi Hospital, Mahidol University Bangkok Krung Thep Maha Nakhon [Bangko
Thailand Siriraj Hospital Bangkok Krung Thep Maha Nakhon [Bangko
Thailand Khon Kaen University, Srinagarind Hospital Khonkaen Khon Kaen
Thailand Prince of Songkla University Songkhla
Turkey Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi Ankara
Turkey Medical Point Gaziantep Hospital Gaziantep
Turkey Izmir Medical Point Hastanesi Izmir
United States University of Maryland Medical Center-Greenebaum Cancer Ctr Baltimore Maryland
United States Our Lady of the Lake Physician Grp MO Baton Rouge Louisiana
United States Hematology-Oncology Associates-CNY East Syracuse New York
United States Ft Wayne Med Oncology Hematology Fort Wayne Indiana
United States Cancer and Blood Specialty Clinic Long Beach California
United States Oncology Hematology Associates Springfield Missouri

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Canada,  Chile,  Croatia,  Czechia,  Estonia,  France,  Georgia,  Germany,  Italy,  Lithuania,  Malaysia,  Mexico,  Philippines,  Portugal,  Romania,  Serbia,  Spain,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response by Week 49 Week 49
Primary Objective response at Week 17 Week 17
Primary Progression-free survival (PFS) From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Primary Overall survival (OS) From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Primary Duration of response (DOR) From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Secondary Number of subjects with treatment-emergent adverse events Week 1 until Week 105
Secondary Number of subjects with treatment-emergent serious adverse events Week 1 until Week 105
Secondary Number of subjects with treatment-emergent adverse events of interest Week 1 until Week 105
Secondary 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
Secondary Serum concentrations of ABP 206 and nivolumab (Ctrough) Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
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