# 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 

Source: https://onco.cc/trials/nct06948448/  
OnCo record `nct06948448` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Nivolumab, CAPOX, Bevacizumab in colorectal cancer, run by Ono Pharmaceutical Co., Ltd., now recruiting.

## Summary

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 is a phase 2 interventional study registered as NCT06948448 by Ono Pharmaceutical Co., Ltd., with 144 participants planned, started 2025-11-18 and due to reach its primary completion in 2028-02-15. Interventions recorded: ONO-4578, Opdivo®, Oxaliplatin, 5-Fluorouracil, Bevacizumab. Conditions listed: Colorectal Cancer. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT06948448
- Phase: 2
- Setting: 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
- Sponsor: Ono Pharmaceutical Co., Ltd.
- Enrolled: 144

## Sources

- ClinicalTrials.gov NCT06948448: https://clinicaltrials.gov/study/NCT06948448

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)](https://onco.cc/drugs/flot/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Deciphera Pharmaceuticals (Ono)](https://onco.cc/companies/deciphera/)

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