Trials / Active Not Recruiting
Active Not RecruitingNCT05144854
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 626 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4538 | Specified dose on specified days |
| DRUG | Ipilimumab | Specified dose on specified days |
| DRUG | Oxaliplatin | Specified dose on specified days |
| DRUG | Capecitabine | Specified dose on specified days |
| DRUG | S-1 | Specified dose on specified days |
Timeline
- Start date
- 2021-11-05
- Primary completion
- 2026-05-01
- Completion
- 2027-05-01
- First posted
- 2021-12-03
- Last updated
- 2024-09-05
Locations
57 sites across 3 countries: Japan, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05144854. Inclusion in this directory is not an endorsement.