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Clinical Trials in the USA / NCT06054555
Active, not recruiting Phase 3

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

NCT06054555 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2023-11-02
Last updated
2026-01-12

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

ABP 206Nivolumab

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (180)

FacilityCityRegionStatus
Cancer and Blood Specialty clinic Long Beach California
Fort Wayne Medical Oncology and Hematology - Office of Clinical Research Fort Wayne Indiana
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion Baton Rouge Louisiana
Oncology Hematology Associates Springfield Missouri
Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP East Syracuse New York
Centro de Investigaciones Médicas y Desarrollo LC Buenos Aires Ciudad Autónoma de Buenos Aire
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology Mar Del Plata Río Negro Province
Clínica Viedma - Oncology Viedma Río Negro Province
Instituto De Oncologia De Rosario Rosario Santa Fe Province
ISIS Clinica Especializada Santa Fe Argentina
Clinical Center University of Sarajevo - Clinic of Oncology Sarajevo Kanton Sarajevo
University Clinical Center of Republic of Srpska Banja Luka Republika Srpska
University Clinical Center Tuzla - Oncology, Hematology and Radio Tuzla Tuzlanski Kanton
Cantonal hospital Zenica - Oncology Zenica Zeničko-dobojski Kanton
Dr. Everett Chalmers Hospital - Oncology Fredericton New Brunswick
Centro de Investigacion y Desarrollo Oncologico Temuco Araucania
IC La Serena Research La Serena Coquimbo Region
Icegclinic Research & Care Estacion Central Santiago Metropolitan
Oncocentro Apys Valparaíso Valparaiso
University Hospital Centre Zagreb - Oncology department Zagreb City of Zagreb
Poliklinika Anova Zagreb City of Zagreb
Klinicki bolnicki centar Osijek Osijek Osjecko-baranjska Županija
FN Hradec Kralove - Klinika onkologie a radioterap Hradec Kralove Moravian-Silesian Region
Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka Prague Czechia
Tartu University Hospital - Oncology Tartu Tartu
CHU de Poitiers Poitier Haute-Vienne
Centre Hospitalier De Saint Malo - Oncologie Rennes Ille-et-Vilaine
C.H.R.U Hopital Claude Huriez - Dermatologie Lille Nord
LTD "High technology hospital MEDCENTER" Batumi Adjara
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
Philipps-University Marburg Marburg Hesse
University Hospital of Cologne Cologne North Rhine-Westphalia
Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico Crema Cremona
IRST Dino Amadori (IRST IRCCS) - UNK Meldola Forli
PO Ospedale San Vincenzo - Oncologia Medica Taormina Messina
Istituto Clinico Humanitas Rozzano Milano

+ 140 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06054555 on ClinicalTrials.gov ↗ ← All trials in the USA