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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

And 80 more locations on ClinicalTrials.gov