A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02743494Tipo: INTERVENTIONALInicio: 14 de jul de 2016Fin estimado: 7 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
Completed pre-operative chemo radiotherapy followed by surgery
Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Criterios de exclusión

Diagnosed with cervical esophageal carcinoma
Diagnosed with Stage IV resectable disease
Did not receive concurrent chemoradiotherapy prior to surgery
Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Intervenciones

drug

Nivolumab

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0050

Capital Federal, Buenos Aires, Argentina

Local Institution - 0152

Capital Federal, Buenos Aires, Argentina

Local Institution - 0164

Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina

Local Institution - 0207

Viedma, Río Negro Province, Argentina

Local Institution - 0208

Rosario, Santa Fe Province, Argentina

Local Institution - 0051

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0198

Buenos Aires, Argentina

Local Institution - 0133

CABA, Argentina

Local Institution - 0112

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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