Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
NCT06948448CI-TRIAL-00118352recruitingPhase 2ClinicalTrials.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 this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Opdivo® | Drug | Nivolumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
- interventionNames
- Drug: ONO-4578
- Drug: Opdivo®
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Bevacizumab
- Drug: Leucovorin
- type
- EXPERIMENTAL
- label
- Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
- interventionNames
- Drug: ONO-4578
- Drug: Opdivo®
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Bevacizumab
- Drug: Leucovorin
- type
- ACTIVE_COMPARATOR
- label
- Arm C SOC (mFOLFOX6+bevacizumab)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection * ECOG Performance Status of 0-1 * No prior systemic treatment for advanced local or mCRC * Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory Exclusion Criteria: * Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor * Participants with BRAF V600E mutation * Unable to swallow tablets. * Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis * Participants with an active, known or suspected autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.