Trial comparing treatments for Colorectal Cancer
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
ClinicalTrials.gov ID: NCT06948448
What this study is testing
What is ONO-4578?
This is an investigational tablet being studied as a potential treatment for advanced colorectal cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- Who it's for
- You may be able to join if you have advanced colorectal cancer that is not MSI-H or dMMR.
- What's involved
- You would get standard chemo and a drug called bevacizumab. You might also get two extra drugs, ONO-4578 and Opdivo.
- Time commitment
- The study involves regular visits to check how well the treatment works and for any side effects.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Rochester, Minnesota, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Temple, Texas, United States
- Norfolk, Virginia, United States
- Salem, Virginia, United States
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Besançon, Doubs, France
- Pessac, Gironde, France
- Nantes, Loire Atlantique, France
- Marseille, Marseille, France
- Paris, Paris, France
- Lyon, Rhone, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Los Angeles, California, United States; Lone Tree, Colorado, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Rochester, Minnesota, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.