Clinical trial · Interventional
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
NCT06538207CI-TRIAL-00085571completedPhase 1ClinicalTrials.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)
This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Levofolinate | Drug | Levoleucovorin | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| ONO-4538 | Drug | Nivolumab | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4578+ONO-4538+mFFX
- interventionNames
- Drug: ONO-4578
- Drug: ONO-4538
- Drug: Oxaliplatin
- Drug: Levofolinate
- Drug: Irinotecan
- Drug: Fluorouracil
- type
- EXPERIMENTAL
- label
- ONO-4578+ONO-4538+GnP
- interventionNames
- Drug: ONO-4578
- Drug: ONO-4538
- Drug: Gemcitabine
- Drug: Nab-Paclitaxel
Primary outcomes (2)
- measure
- Dose-limiting toxicities（DLT）
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Pancreatic invasive ducatal adenocarcinoma * 2\. Life expectancy of at least 3 months * 3\. Patients with ECOG performance status 0 or 1 Exclusion Criteria: * 1\. Patients with severe complication * 2\. Patients with multiple primary cancers
References
Publications (0)
Data not yet available
No reference posted for this study.