A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03470922Tipo: INTERVENTIONALInicio: 11 de abr de 2018Fin estimado: 15 de dic de 2030

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Criterios de exclusión

Participants must not have active brain metastases or leptomeningeal metastases
Participants must not have uveal melanoma
Participants must not have an active, known, or suspected autoimmune disease

Intervenciones

biological

Relatlimab

Specified dose on specified day

biological

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0135

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0002

Capital Federal, Distrito Federal, Argentina

Local Institution - 0004

Buenos Aires, Argentina

Local Institution - 0003

Buenos Aires, Argentina

Local Institution - 0005

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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