A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

TerminadoFase 3ClinicalTrials.gov

ID: NCT05002569Tipo: INTERVENTIONALInicio: 19 de oct de 2021Fin estimado: 2 de abr de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Must have been diagnosed with either Stage IIIA (\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
Complete resection must be performed within 90 days prior to randomization
All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
Tumor tissue must be provided for biomarker analyses

Criterios de exclusión

History of myocarditis, regardless of etiology.
History of ocular melanoma
Untreated/unresected CNS metastases or leptomeningeal metastases
Active, known, or suspected autoimmune disease
Participants with serious or uncontrolled medical disorder
Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening

Intervenciones

biological

Nivolumab + Relatlimab Fixed Dose Combination

Specified dose on specified days

biological

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0003

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0005

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0001

CABA, Distrito Federal, Argentina

Local Institution - 0002

Ciudad de Buenos Aires, Distrito Federal, Argentina

Local Institution - 0004

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Randomized, Double-blind Study of Adjuvant Imm... | EligiMed