A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

CompletadoFase 3ClinicalTrials.gov

ID: NCT01721772Tipo: INTERVENTIONALInicio: 18 de ene de 2013Fin estimado: 14 de may de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Men and women ≥18 years of age
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Criterios de exclusión

Active brain metastases or leptomeningeal metastases
Ocular melanoma
Any active, known, or suspected autoimmune disease

Intervenciones

biological

BMS-936558 (Nivolumab)

biological

Placebo matching BMS-936558 (Nivolumab)

drug

Dacarbazine

drug

Placebo matching Dacarbazine

Ubicaciones

Fundacion Cidea

Buenos Aires, Distrito Federal, Argentina

Instituto Medico Especialazado Alexander Fleming

Buenos Aires, Argentina

Instituto Oncologico De Cordoba

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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