Gastric cancer, gastroesophageal junction cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Nivolumab, Ipilimumab, Oxaliplatin, Capecitabine, Leucovorin, Fluorouracil
INN of investigational material : Nivolumab, Ipilimumab, Oxaliplatin, Capecita
Sponsors
ONO PHARMACEUTICAL CO.,LTD.
Bristol-Myers Squibb (BMS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out 2.Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months 3.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 4.Must agree to provide tumor tissue sample.
Exclusion criteria
Exclusion criteria: 1.Presence of tumor cells in the brain or spinal cord that have not been treated 2.Active known or suspected autoimmune disease 3.Any serious or uncontrolled medical disorder or active infection 4.Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) 5.Any positive test result for hepatitis B or C indicating acute or chronic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall survival (OS) in programmed cell death ligand 1 (PD-L1) positive participants Progression-free survival (PFS) in programmed cell death ligand 1 (PD-L1) positive participants | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy OS in all randomized subjects, Progression-free Survival (PFS) in subjects all randomized subjects, Time to Symptom Deterioration (TTSD) assessed with Gastric Cancer Subscale (GaCS) questionnaire in subjects with all randomized subjects | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed