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  • NCT02872116

Active, Not Recruiting

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer - CA209-649

Oppdatert: 30 november, 2023   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Drug: Oxaliplatin, Leucovorin, Fluorouracil
Experimental: Nivolumab + FOLFOX
Drug: Nivolumab, Fluorouracil, Leucovorin, Oxaliplatin
Experimental: Nivolumab + Ipilimumab
Drug: Ipilimumab, Nivolumab
Experimental: Nivolumab + XELOX
Drug: Nivolumab, Capecitabine, Oxaliplatin
Active Comparator: XELOX (Oxaliplatin + Capecitabine)
Drug: Capecitabine, Oxaliplatin

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 Exclusion Criteria: - 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) - Any positive test result for hepatitis B or C indicating acute or chronic infection Other protocol defined inclusion/exclusion criteria could apply

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046