A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

CompletadoFase 3ClinicalTrials.gov

ID: NCT03143153Tipo: INTERVENTIONALInicio: 29 de jun de 2017Fin estimado: 13 de ene de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
Male or Female at least 18 years of age
Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Criterios de exclusión

Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
Active known or suspected autoimmune disease
Any serious or uncontrolled medical disorder or active infection
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus

Intervenciones

biological

Nivolumab

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

drug

Cisplatin

Specified dose on specified days

drug

Fluorouracil

Specified dose on specified days

Ubicaciones

Local Institution - 0048

Buenos Aires, Buenos Aires, Argentina

Local Institution - 0050

Capital Federal, Buenos Aires, Argentina

Local Institution - 0087

La Rioja, La Rioja Province, Argentina

Local Institution - 0086

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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