Clinical trial · Interventional
Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
NCT02267343CI-TRIAL-00076752completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538 | Drug | Nivolumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4538 Arm
- description
- ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- interventionNames
- Drug: ONO-4538
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Men \& women ≥20 years of age * Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) * Histologically confirmed adenocarcinoma * Refractory to or intolerant of standard therapy * ECOG Performance Status score 0 or 1 * A life expectancy of at least 3 months Exclusion Criteria: * Current or past history of severe hypersensitivity to any other antibody products * Patients with multiple primary cancers * Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment * Patients with active, known or suspected autoimmune disease
References
Publications (2)
- DERIVEDKang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273. PMID 35383114
- DERIVEDKang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6. PMID 28993052