Clinical trial · Interventional
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer
NCT06540261CI-TRIAL-00080482active not recruitingPhase 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)
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal 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 |
|---|---|---|---|
| Unresectable Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Levofolinate | Drug | Levoleucovorin | ALIAS |
| ONO-4538 | Drug | Nivolumab | ALIAS |
| ONO-7913 | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-7913＋ONO-4538＋FOLFOX＋Bev
- interventionNames
- Drug: ONO-7913
- Drug: ONO-4538
- Drug: Fluorouracil
- Drug: Oxaliplatin
- Drug: Levofolinate
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- ONO-7913＋ONO-4538＋FOLFOX＋Cet
- interventionNames
- Drug: ONO-7913
- Drug: ONO-4538
- Drug: Fluorouracil
- Drug: Oxaliplatin
- Drug: Levofolinate
- Drug: Cetuximab
Primary outcomes (2)
- measure
- Dose-limiting toxicities（DLT）
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unresectable advanced or recurrent colorectal cancer 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.