Actively Recruiting
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
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-03-27
144
Participants Needed
28
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 metastatic colorectal cancer
- Tumor positive for PD-L1 expression as determined at a central laboratory
- Adults aged 18 years and older
You will not qualify if you...
- High microsatellite instability (MSI-High) or mismatch repair deficient (dMMR) tumor
- Presence of BRAF V600E mutation
- Unable to swallow tablets
- History or complication of interstitial lung disease, pneumonitis, or pulmonary fibrosis
- Active, known or suspected autoimmune disease
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or other drugs targeting immune checkpoint pathways
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43221
Actively Recruiting
6
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
Baylor Scott & White Medical Center
Temple, Texas, United States, 76508
Actively Recruiting
8
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
9
Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Actively Recruiting
10
Princess Margaret Cancer Centre- University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
11
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
Actively Recruiting
12
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, France
Actively Recruiting
13
Chru De Nantes Hotel-Dieu
Nantes, Loire Atlantique, France
Actively Recruiting
14
Hôpital de la Timone
Marseille, Marseille, France
Actively Recruiting
15
Hôpital Européen Georges Pompidou
Paris, Paris, France
Actively Recruiting
16
Hôpital Saint-Antoine
Paris, Paris, France
Actively Recruiting
17
Centre Leon Berard
Lyon, Rhone, France
Actively Recruiting
18
CHU Poitiers - Hôpital la Milétrie
Poitiers, Vienne, France
Actively Recruiting
19
Istituto Clinico Humanitas
Milan, Italy, Italy
Actively Recruiting
20
Istituto Europeo di Oncologia
Milan, Italy, Italy
Actively Recruiting
21
Kobe City Medical Center General Hospital
Hyōgo, Kobe-shi, Japan
Actively Recruiting
22
National Hospital Organization Osaka National Hospital
Osaka, Osaka-shi, Japan
Actively Recruiting
23
Osaka General Medical Center
Osaka, Osaka-shi, Japan
Actively Recruiting
24
Osaka International Cancer Institute
Osaka, Osaka-shi, Japan
Actively Recruiting
25
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Actively Recruiting
26
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Actively Recruiting
27
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Actively Recruiting
28
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Actively Recruiting
Research Team
N
North America Clinical Trial Support Desk
CONTACT
I
International Clinical Trial Support Desk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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