None listed
Conditions
Interventions
Nivolumab-plus-Ipilimumab Arm.
Nivolumab (solution for inyection) 1mg/kg administered IV over 30 minutes followed by ipilimumab (Solution for inyection 5mg/mL) 3mg/kg administered IV over
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) All subjects must have inoperable, advanced, locally advanced or metastatic GC or GEJ carcinoma and have histologically confirmed predominant adenocarcinoma. 2) Subject must be previously untreated with systemic treatment including HER 2 inhibitors given as primary therapy for advanced or metastatic disease. 3) Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the prior regimen (whichever was given last) occurred at least 6 months prior to randomization. 4) Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria. 5) ECOG performance status score of 0 or 1. 6) Tumor tissue must be provided for PD-L1 biomarker analyses prior to randomization.
Exclusion criteria
Exclusion criteria: 1) Known Her2 positive status. 2) Subjects with untreated CNS metastases. 3) Subjects with ascites which cannot be controlled with appropriate interventions. 4) Subjects with > Grade 1 peripheral neuropathy. 5) c) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. 6) d) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 7) Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Countries
Canada, Cape Verde, Chad, China, France, Greece, Hungary, Italy, Japan, Korea South, Peru, Poland, Portugal, Romania, Spain, Taiwan, United States
Contacts
Public ContactEddy Dumler
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed