ONO-4578-10:A study to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo(R), in combination with mFOLFOX6 and bevacizumab versus standard of care in participants with non-MSI-H/dMMR, PD-L1 positive advanced colorectal cancer.

ONO-4578-10:A randomized, open label, multicenter, Phase 2 study to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo(R) 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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250119

Enrollment

144

Registered

2025-09-29

Start date

2025-10-10

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced colorectal cancer

Interventions

ONO-4578, nivolumab, chemotherapy (oxaliplatin, fluorouracil, and levofolinate calcium hydrate [mFOLFOX6 regimen]), and bevacizumab will be used in combination.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Safety and Efficacy(ORR)	—

Secondary

Measure	Time frame
Safety and Efficacy(OS, PFS and others)	—

Countries

Canada, France, Italy, Japan, Spain, USA

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026