Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

620

Study ID:

NCT06054555

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 77 Locations for this study

See Locations Near You

Cancer and Blood Specialty Clinic
Long Beach California, 90806, United States
Ft Wayne Med Oncology Hematology
Fort Wayne Indiana, 46804, United States
Our Lady of the Lake Physician Grp MO
Baton Rouge Louisiana, 70805, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr
Baltimore Maryland, 21201, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
Hematology-Oncology Associates-CNY
East Syracuse New York, 13057, United States
University Clinical Center of Republic of Srpska
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar , 88000, Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo , 71000, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla , 75000, Bosnia and Herzegovina
Cantonal hospital Zenica
Zenica , 72000, Bosnia and Herzegovina
Dr. Everett Chalmers Hospital
Fredericton New Brunswick, E3B 5, Canada
University Hospital Centre Zagreb
Zagreb Grad Zagreb, 10 00, Croatia
Poliklinika Anova
Zagreb Grad Zagreb, 10000, Croatia
Klinicki bolnicki centar Osijek
Osijek Osjecko-baranjska Županija, 31000, Croatia
FN Hradec Kralove
Hradec Kralove , 500 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
East Tallinn Central Hospital
Tallinn , , Estonia
Tartu University Hospital
Tartu , 51014, Estonia
CHU de Poitiers
Poitiers Haute-Vienne, 21079, France
C.H.R.U Hopital Claude Huriez - Dermatologie
Lille Nord, 59037, France
ISR-GEO Med Res Clin Healthycore
Tbilisi , 0112, Georgia
LLC "Todua Clinic"
Tbilisi , 0112, Georgia
JSC KE Nat Ctr of Exp and Clin Surg
Tbilisi , 0159, Georgia
Multprofil Clinic Consilium Medulla
Tbilisi , 0186, Georgia
University Hospital Cologne AöR
Köln Nordrhein-Westfalen, 50937, Germany
PO Ospedale San Vincenzo
Taormina Messina, 98039, Italy
Istituto dei Tumori "Giovanni Paolo II"
Bari , 70124, Italy
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
AOU Careggi
Firenze , 50134, Italy
Ospedale San Raffaele, IRCCS
Milano , 20132, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milano , 20141, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli , 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
Roma , 00144, Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
Roma , 00167, Italy
AOU Senese, Policlinico Le Scotte
Siena , 53100, Italy
Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi
Varese , 21100, Italy
National Cancer Institute
Vilnius , LT-08, Lithuania
Hospital Universiti Sains Malaysia
Kubang Kerian Kelantan, 16150, Malaysia
Hospital Pulau Pinang
Pulau Pinang Pahang, , Malaysia
Sarawak General Hospital
Kuching Sarawak, , Malaysia
Institut Kanser Negara
Putrajaya Selangor, 62250, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 56000, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur Wilayah Persekutuan Kuala Lump, 59100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur Wilayah Persekutuan Kuala Lump, , Malaysia
Preparaciones Oncologicas SC
Leon Guanajuato, C. P., Mexico
Centro Inmuno Oncolog de Occidente
Guadalajara Jalisco, 44630, Mexico
I CAN ONCOLOGY CENTER SA de CV
Monterrey Nuevo León, 64710, Mexico
Cent de Estud y Prev del Cancer AC
Juchitan Oaxaca, 70000, Mexico
Ctro At Inv Cardio Potosi
San Luis Potosi San Luis Potosí, 78200, Mexico
Neurociencias Estudios Clínicos SC
Culiacan Sinaloa, 80020, Mexico
Centro De Atenc E Inv Clín En Onco
Merida Yucatán, 97134, Mexico
Boca Clinical Trials México
Guadalajara , , Mexico
Oncare Viaducto Napoles
Mexico City , 14080, Mexico
Clinica Integral Internac Oncologia
Puebla , 72530, Mexico
Althian Research Management Center
San Pedro Garza Garcia , 66278, Mexico
Centro Medico Zambrano Hellion
San Pedro Garza García , 66278, Mexico
Clinical Research Institute S.C.
Tlalnepantla de Baz , , Mexico
Champalimaud Foundation - Champalimaud Centre for the Unknown (Champalimaud Cancer Center)
Lisboa , 1400-, Portugal
Hospital de São Francisco Xavier
Lisboa , 1449-, Portugal
Hospital da Luz
Lisboa , 1500-, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisboa , , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca Cluj, 40001, Romania
Radiotherapy Center Cluj
Floresti Cluj, 40728, Romania
Centrul de Oncologie Sf. Nectarie
Craiova Dolj, 20074, Romania
Oncocenter-Oncologie Clinica
Timisoara Timis, 30016, Romania
Medisprof
Cluj-Napoca , 40064, Romania
Centrul de Oncologie Euroclinic
Iasi , 70010, Romania
Spitalul Clinic Judetean De Urgenta Sibiu
Sibiu , 55024, Romania
Vojvodina Institute for Oncology
Sremska Kamenica Vojvodina, 21204, Serbia
University Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Hospital Universitario Virgen De La Macarena
Sevilla Andalucía, 41009, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital San Pedro de Alcántara
Caceres Cáceres, 10003, Spain
M.D. Anderson Center Madrid
Madrid, Madrid, 28033, Spain
H.U.V.Arrixaca
El Palmar Murcia, Región De, 30120, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitari Vall D Hebron
Barcelona , 08035, Spain
Hospital Regional Universitario de Malaga
Málaga , 29011, Spain
Hospital Jerez Puerta Del Sur
Sevilla , 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia , 46014, Spain
Khon Kaen University, Srinagarind Hospital
Khonkaen Khon Kaen, 40002, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok Krung Thep Maha Nakhon [Bangko, 10400, Thailand
Siriraj Hospital
Bangkok Krung Thep Maha Nakhon [Bangko, 10700, Thailand
Prince of Songkla University
Songkhla , 90110, Thailand

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

620

Study ID:

NCT06054555

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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