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ACTIVE NOT RECRUITING
NCT06054555
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

633

Start Date

2023-11-02

Completion Date

2028-01-25

Last Updated

2026-01-12

Healthy Volunteers

No

Conditions

Interventions

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.

DRUG

Nivolumab

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

Locations (180)

Cancer and Blood Specialty clinic

Long Beach, California, United States

Fort Wayne Medical Oncology and Hematology - Office of Clinical Research

Fort Wayne, Indiana, United States

Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion

Baton Rouge, Louisiana, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP

East Syracuse, New York, United States

Centro de Investigaciones Médicas y Desarrollo LC

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

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

Mar Del Plata, Río Negro Province, Argentina

Clínica Viedma - Oncology

Viedma, Río Negro Province, Argentina

Instituto De Oncologia De Rosario

Rosario, Santa Fe Province, Argentina

ISIS Clinica Especializada

Santa Fe, Argentina

Clinical Center University of Sarajevo - Clinic of Oncology

Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina

University Clinical Center of Republic of Srpska

Banja Luka, Republika Srpska, Bosnia and Herzegovina

University Clinical Center Tuzla - Oncology, Hematology and Radio

Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina

Cantonal hospital Zenica - Oncology

Zenica, Zeničko-dobojski Kanton, Bosnia and Herzegovina

Dr. Everett Chalmers Hospital - Oncology

Fredericton, New Brunswick, Canada

IC La Serena Research

La Serena, Coquimbo Region, Chile

Centro de Investigacion y Desarrollo Oncologico

Temuco, Región de la Araucanía, Chile

Oncocentro Apys

Valparaíso, Región de Valparaíso, Chile

Icegclinic Research & Care

Estacion Central, Santiago Metropolitan, Chile

University Hospital Centre Zagreb - Oncology department

Zagreb, City of Zagreb, Croatia

Poliklinika Anova

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Osijek

Osijek, Osjecko-baranjska Županija, Croatia

FN Hradec Kralove - Klinika onkologie a radioterap

Hradec Kralove, Moravskoslezský kraj, Czechia

Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka

Prague, Czechia

Tartu University Hospital - Oncology

Tartu, Tartu, Estonia

CHU de Poitiers

Poitier, Haute-Vienne, France

Centre Hospitalier De Saint Malo - Oncologie

Rennes, Ille-et-Vilaine, France

C.H.R.U Hopital Claude Huriez - Dermatologie

Lille, Nord, France

LTD "High technology hospital MEDCENTER"

Batumi, Adjara, Georgia

LLC "Todua Clinic"

Tbilisi, Georgia

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

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

Tbilisi, Georgia

LTD "Multprofile Clinic Consilium Medulla" - Oncology

Tbilisi, Georgia

Goethe University Frankfurt

Frankfurt am Main, Hesse, Germany

Philipps-University Marburg

Marburg, Hesse, Germany

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico

Crema, Cremona, Italy

IRST Dino Amadori (IRST IRCCS) - UNK

Meldola, Forli, Italy

PO Ospedale San Vincenzo - Oncologia Medica

Taormina, Messina, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

AO Ss Antonio, Biagio e Arrigo

Alessandria, Italy

AUO Consorziale-Policlinico Bari

Bari, Italy

Istituto dei Tumori Giovanni Paolo II - Oncologia Medica - Tumori Rari e Melanoma

Bari, Italy

ASST Papa Giovanni XXIII - Oncologia

Bergamo, Italy

AOU Careggi

Florence, Italy

IRCCS Ca'Granda Maggiore Policlinic

Milan, Italy

Ospedale San Raffaele, IRCCS - Oncologia Medica

Milan, Italy

AOU Luigi Vanvitelli

Naples, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare

Naples, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica

Roma, Italy

IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)

Roma, Italy

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

Roma, Italy

Ospedale Isola Tiberina - Gemelli Isola - Oncologia Medica

Roma, Italy

AOU Senese, Policlinico Le Scotte

Siena, Italy

Ospedale di Circolo, Presidio di Varese - Oncologia

Varese, Italy

Al Khalidi Hospital and Medical Center - Research

Amman, 'Ammān, Jordan

The Speciality Hospital (TSH) / Advanced Clinical Center

Amman, 'Ammān, Jordan

King Hussein Cancer Center

Amman, Jordan

Pharmaceutical Research Center (KAUH)

Irbid, Jordan

Saint George Hospital University Medical Center

El Achrafiyé, Beyrouth, Lebanon

Nini Hospital

Tripoli, Loubnâne Ech Chemâli, Lebanon

Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology

Saida, Loubnâne Ej Jnoûbi, Lebanon

Ain Wazein Hospital - internal medicine

Beirut, Lebanon

American University of Beirut Medical Center - Haematology

Beirut, Lebanon

Hotel Dieu de France Hospital - Oncology

Beirut, Lebanon

National Cancer Institute - Conservative Tumour Therapy

Vilnius, Vilnius County, Lithuania

Hospital Pulau Pinang

Pulau Pinang, Pahang, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

National Cancer Institute - Radiotherapy and Oncology

Putrajaya, Selangor, Malaysia

HOSPITAL UNIVERSITI SAINS MALAYSIA - Pediatrics

Kubang Kerian, Terengganu, Malaysia

Hospital Kuala Lumpur - Surgery

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia

Hospital Canselor Tuanku Muhriz UKM

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia

Pantai Hospital Kuala Lumpur - Oncology

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia

Preparaciones Oncologica SC

León, Guanajuato, Mexico

Centro de Inm Onc de Occ Sa de Cv

Guadalajra, Jalisco, Mexico

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico City, Mexico

iCan Oncology Center Centro Medico AVE

Monterrey, Nuevo León, Mexico

Centro Medico Zambrano Hellion TecSalud

Monterrey, Nuevo León, Mexico

Althian - Research Management Center

San Pedro Garza García, Nuevo León, Mexico

Centro de Estudios y Prevención del Cancer AC

Juchitán de Zaragoza, Oaxaca, Mexico

Hospital Angeles Centro Médico San Luis Potosí - Cardiologia

San Luis Potosí City, San Luis Potosí, Mexico

Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.

Culiacán, Sinaloa, Mexico

Centro de Atención e Investigación Clínica en Oncología

Mérida, Yucatán, Mexico

Centro de Investigación Médica Aguascalientes (CIMA) - Oncology

Aguascalientes, Mexico

Boca Clinical Trials México

Guadalajara, Mexico

Oncare Cancer Center Viaducto CdMx

Mexico City, Mexico

ONCOCENTER PUEBLA - Dermatology

Puebla City, Mexico

Clinical Research Institute

Tlalnepantla, Mexico

Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology

Chisinau, Moldova, Republic of, Moldova

Amphia Ziekenhuis - Molengracht

Breda, North Brabant, Netherlands

Baguio General Hospital and Medical Center - Oncology

Baguio City, Benguet, Philippines

Cebu Doctors' University Hospital - Oncology

Cebu City, Cebu, Philippines

The Medical City - Clinical Research Unit

Iloilo City, Iloilo, Philippines

The Medical City - Neurology

Pasig, Metropolitan Manila, Philippines

Cagayan de Oro Medical Center - Internal Medicine

Cagayan de Oro, Misamis Oriental, Philippines

Center for Skin Research, Testing and Product Development

Makati City, National Capital Region, Philippines

Philippine General Hospital

Manila/Ermita, National Capital Region, Philippines

Cardinal Santos Madical Center

San Juan City, National Capital Region, Philippines

Riverside Medical Center

Bacolod, Negros Occidental, Philippines

Centro Hospitalar de Setúbal - Oncologia

Setúbal, Setúbal District, Portugal

Champalimaud Cancer Center

Lisbon, Portugal

Unidade Local De Saude De Lisboa Ocidental E.P.E.

Lisbon, Portugal

Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

Lisbon, Portugal

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica

Lisbon, Portugal

Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica

Porto, Portugal

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Medical Oncology

Cluj-Napoca, Cluj, Romania

Medisprof - Medical Oncology

Cluj-Napoca, Cluj, Romania

Radiotherapy Center Cluj - Medical Oncology

Floreşti, Cluj, Romania

Oncolab - Medical Oncology

Craiova, Dolj, Romania

Centrul de Oncologie Sf Nectarie - Medical Oncology

Craiova, Dolj, Romania

Medical Center Gral

Ploieşti, Prahova, Romania

Spitalul Municipal Ploiesti - Oncologie

Ploieşti, Prahova, Romania

Oncocenter- Oncologie Clinica - Medical Oncology

Timișoara, Timiș County, Romania

Memorial Healthcare International - Oncology

Bucharest, Romania

Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Medical Oncology I

Bucharest, Romania

Centrul de Oncologie Euroclinic - Oncology

Iași, Romania

Spitalul Clinic Judetean de Urgenta Sibiu - Oncologie

Sibiu, Romania

Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B

Kamenitz, Vojvodina, Serbia

University Clinical Center of Kragujevac, Center for Internal Oncology

Kragujevac, Šumadijski Okrug, Serbia

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Wits Clinical Research

Parktown, Johannesburg, Gauteng, South Africa

Steve Biko Academic Hospital

Pretoria, Gauteng, South Africa

Curo Oncology

Pretoria, Gauteng, South Africa

Little Company Of Mary Hospital - Oncology

Pretoria, Gauteng, South Africa

Rainbow Oncology Centre

Durban, KwaZulu-Natal, South Africa

Cape Gate Oncology Centre

Cape Town, Western Cape, South Africa

Cancercare - Rondebosch Oncology

Cape Town, Western Cape, South Africa

Inje University Haeundae Paik Hospital - Oncology

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

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

Suwon, Gyeonggido [Kyonggi-do], South Korea

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

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

Asan Medical Center - Oncology

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

Samsung Medical Center - Family Medicine

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

Hospital Universitario Virgen de la Macarena - Oncología Médica

Seville, Andalusia, Spain

Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica

Badalona, Barcelona, Spain

Hospital San Pedro de Alcántara - Oncología

Cáceres, Cáceres, Spain

H.U.V.Arrixaca - Oncología

El Palmar, Murcia, Región de, Spain

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau - Oncología Médica

Barcelona, Spain

M.D. Anderson Center Madrid

Madrid, Spain

Hospital Regional Universitario de Malaga - Servicio de Oncología

Málaga, Spain

Hospital HLA Jerez Puerta Sur

Seville, Spain

Consorcio Hospital General Universitario de Valencia - Oncología

Valencia, Spain

China Medical University Hospital - Internal Medicine

Taichung, Taichung Municipality, Taiwan

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

New Taipei City, Taipei, Taiwan

Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine

Changhua, Taiwan

Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology

Taipei, Taiwan

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

Khonkaen, Changwat Khon Kaen, Thailand

Prince of Songkla University

Songkhla, Changwat Songkhla, Thailand

Maharaj Nakorn Chiangmai Hospital - Medical Oncology

Muang, Chiang Mai, Thailand

King Chulalongkorn Memorial Hospital [Medical Oncology]

Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

Siriraj Hospital - Medical Oncology

Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

Ramathibodi Hospital - Immunology and Rheumatology

Rajthevi, Krung Thep Maha Nakhon [Bangko, Thailand

Gazi University Medical Faculty - Gynecology

Yenimahalle/Ankara, Ankara, Turkey (Türkiye)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

Kadıköy, Istanbul, Turkey (Türkiye)

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Gulhane Training and Research Hospital - Medical Oncology

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty - Medical Oncology

Ankara, Turkey (Türkiye)

Ankara Liv Hospital

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital - Oncology

Ankara, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

Ankara, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Medical Point Gaziantep Hospital - Medical Oncology

Gaziantep, Turkey (Türkiye)

Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and

Gaziantep, Turkey (Türkiye)

Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology

Istanbul, Turkey (Türkiye)

Koc Universitesi Hastanesi; Tıbbi Onkoloji

Istanbul, Turkey (Türkiye)

Memorial Bahçelievler Hospital

Istanbul, Turkey (Türkiye)

Izmir Medical Point Hastanesi

Izmir, Turkey (Türkiye)

Kocaeli University Research and Practice Hospital - Medical Oncology

Kocaeli, Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty - Oncology

Konya, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

VM Medical Park Samsun Hospital - Medical oncology

Samsun, Turkey (Türkiye)

Namik Kemal Universitesi - Tip Fakultesi

Tekirdağ, Turkey (Türkiye)

TOV "ARENSIIa EKSPLORATORI MEDISIN"

Kyiv, Kyïv, Ukraine

Hanoi Oncology Hospital

Hanoi, Ha Noi, Thu Do, Vietnam

Vietnam National Cancer Hopsital

Hanoi, Ha Noi, Thu Do, Vietnam

HCM Oncology Hospital - Medical Oncology

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