Gastric Cancer
Conditions
Brief summary
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Interventions
DRUGONO-4578
Specified dose, once daily
DRUGOxaliplatin
Specified dose on specified days
DRUGCapecitabine
Specified dose on specified days
DRUGS-1
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGPlacebo
Specified dose, once daily
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma * Patients have not been treated with systemic chemotherapy as first-line therapy * Patients who can provide tumor tissue samples
Exclusion criteria
* Patients unable to take oral medicines * Patients with HER2-positive * Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine * Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment * Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis * Patients with headache and/or nausea associated with brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) (site investigator assessment) | up to 2years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to 2years | — |
| Objective response rate (ORR) (site investigator assessment) | up to 2years | — |
| Best overall response (BOR) (site investigator assessment) | up to 2years | — |
| Duration of response (DOR) (site investigator assessment) | up to 2years | — |
| Disease control rate (DCR) (site investigator assessment) | up to 2years | — |
| Time to response (TTR) (site investigator assessment) | up to 2years | — |
| Maximum percent change in the sum diameters of the target lesions (site investigator assessment) | up to 2years | — |
| Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) | up to 2years | — |
| Adverse event (AE) | Up to 30 days after the last dose | Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 |
Countries
Japan, South Korea, Taiwan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co. Ltd
Outcome results
None listed