A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02872116Tipo: INTERVENTIONALInicio: 12 de oct de 2016Fin estimado: 6 de jun de 2024

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Resumen

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or Female at least 18 years of age
Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
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

Any positive test result for hepatitis B or C indicating acute or chronic infection
Presence of tumor cells in the brain or spinal cord that have not been treated
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)