Last updated 3 days ago

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

620 patients around the world

Available in Spain, Mexico, United States, Argentina

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.

Amgen

16Research sites

620Patients around the world

This study is for people with

Skin cancer

Melanoma

Requirements for the patient

To 99 Years

All Gender

Medical requirements

: 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.

: 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.

Sites

Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro

Recruiting

25 de mayo 174, Viedma, Río Negro

Centro de Investigaciones Médicas Mar del Plata SRL

Recruiting

Av. Colón 3083, Mar del Plata, Buenos Aires

Instituto de Oncología de Rosario - IOR

Recruiting

Córdoba 2457, Rosario, Santa Fe

Fundación CENIT para la Investigación en Neurociencias

Recruiting

Juncal 2222, C1125 CABA, Argentina

Isis Clínica Especializada - Santa Fe

Recruiting

Urquiza 3077, Santa Fe

Oncocentro APYS - Valparaíso

Recruiting

Avenida La Marina 1702, Viña del Mar, Valparaíso

Centro de Investigación Médica Aguascalientes - CIMA

Recruiting

Av Independencia 2130, Trojes de Alonso, Aguascalientes

Centro Médico Zambrano Hellion

Recruiting

Av. Batallón de San Patricio 112, Monterrey, Nuevo León

CIO - Centro de Inmuno-Oncología de Occidente

Recruiting

Calle Santa Fe 3078, Colonia Providencia 5a sección, C.P. 44630 Guadalajara, Jalisco

Clinical Research Institute S.C.

Recruiting

Blvd. Manuel Ávila Camacho 1994, Colonia San Lucas Tepetlacalco, Tlalnepantla de Baz, Ciudad de México

SponsorAmgen

Conditions

Melanoma

Requirements

To 99 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06054555