Recruiting

Phase 2

ONO-4578 & OpdivoA 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

Sponsor:

Ono Pharmaceutical Co., Ltd.

Code:

NCT06948448

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ONO-4578

Opdivo®

Oxaliplatin

5-Fluorouracil

Bevacizumab

Study Details

Brief summary:

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

Colorectal Cancer

Study ID

NCT06948448

Start date

Nov 18, 2025

Status verified date

Jul, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Feb 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)

experimental: Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)

active comparator: Arm C SOC (mFOLFOX6+bevacizumab)

Interventions

ONO-4578

ONO-4578 tablets once a day

Opdivo®