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
Public ClinicalTrials.gov record NCT06948448. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06948448
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Industry
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Interventions
- 5-Fluorouracil Drug
- Bevacizumab Drug
- Leucovorin Drug
- ONO-4578 Drug
- Opdivo® Drug
- Oxaliplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 17, 2025
- Primary completion
- Feb 14, 2028
- Completion
- Sep 30, 2028
- Last update posted
- May 17, 2026
2025 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | 80124 | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Recruiting |
| Advent Health | Orlando | Florida | 32803 | Recruiting |
| May Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43221 | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Baylor Scott & White Medical Center | Temple | Texas | 76508 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
| Blue Ridge Cancer Care | Salem | Virginia | 24153 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06948448, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2026 · Synced May 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06948448 live on ClinicalTrials.gov.