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NCT06948448 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Colorectal Cancer, sponsored by Ono Pharmaceutical Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 17
- Study locations
NCT06948448: Recruiting Phase 2 study of Colorectal Cancer, sponsored by Ono Pharmaceutical Co..
NCT06948448 is a Phase 2 study of Colorectal Cancer that is actively recruiting participants, run by Ono Pharmaceutical Co.. The registered enrollment target is 144 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06948448, a Phase 2 study of Colorectal Cancer, is actively recruiting participants, sponsored by Ono Pharmaceutical Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
ORR (assessed by BICR per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by BICR per RECIST v1.1 divided by the total number of participants.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
- DRUG ONO-4578
- DRUG Opdivo®
Study Locations (17)
Osaka-shi
- National Hospital Organization Osaka National Hospital - Osaka
- Osaka General Medical Center - Osaka
- Osaka International Cancer Institute - Osaka
Paris
- Hôpital Européen Georges Pompidou - Paris
- Hôpital Saint-Antoine - Paris
Arizona
- Mayo Clinic Arizona - Phoenix
California
- USC Norris Comprehensive Cancer Center - Los Angeles
Colorado
- Rocky Mountain Cancer Centers, LLP - Lone Tree
Florida
- Mayo Clinic Florida - Jacksonville
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Texas
- Baylor Scott & White Medical Center - Temple
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-11-18 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
What NCT06948448 shows while recruiting
NCT06948448 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT06948448 lists 17 locations in 14 states (Osaka-shi, Paris, Arizona).
Frequently Asked Questions
What is clinical trial NCT06948448 about?
NCT06948448 is a clinical study titled "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". 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.
What is the current status of trial NCT06948448?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2025-11-18. Estimated completion is 2028-10-01.
What conditions does trial NCT06948448 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT06948448?
The interventions under investigation include: Bevacizumab (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), ONO-4578 (DRUG), Opdivo® (DRUG).
Who is sponsoring clinical trial NCT06948448?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06948448 being conducted?
This trial has 17 study locations across Arizona, California, Colorado, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06948448's enrollment target sits among peer trials
144 176th of 381 higher than 206 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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