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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06054555Tipo: INTERVENTIONALInicio: 2 de nov de 2023Fin estimado: 25 de ene de 2028

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Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

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.

Ubicaciones

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

Patrocinadores

PrincipalAmgen

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