Study on the Safety and Effectiveness of Two Doses of ONO-4578 with Opdivo®, Combined with mFOLFOX6 and Bevacizumab, Compared to Standard Treatment for Advanced Colorectal Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
ClinicalTrials ID:NCT06948448
This clinical trial is testing two different doses of the drug ONO-4578 with Opdivo®, combined with chemotherapy and bevacizumab, to see if they are safe and effective as a first treatment for advanced colorectal cancer that is PD-L1 positive.
Patient Parameters
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Program Overview
The aim of this study is to determine if two different doses of ONO-4578, when used with Opdivo® and combined with chemotherapy drugs mFOLFOX6 and bevacizumab, are safe and effective for treating advanced colorectal cancer. This will be compared to the standard treatment currently used for this type of cancer.
Description
Participants who join the study will first go through a consent and screening process to ensure they are eligible. Those who qualify will be randomly assigned to one of three treatment groups. Each group will receive a different combination of the study drugs or the standard treatment. The treatments will be given in cycles lasting 28 days each. Participants will continue with the treatment until their cancer worsens, they experience severe side effects, the doctor decides to stop the treatment, they choose to leave the study, or the study is ended by the sponsor.
Eligibility Criteria
Inclusion Criteria
- Have advanced colorectal cancer that cannot be removed by surgery.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have not received any previous treatment for advanced colorectal cancer.
- Have a tumor that tests positive for PD-L1 expression.
Exclusion Criteria
- Have a type of colorectal cancer with high microsatellite instability (MSI-High) or mismatch repair deficiency (dMMR).
- Have a specific genetic mutation known as BRAF V600E.
- Be unable to swallow tablets.
- Have a history of lung diseases like interstitial lung disease, pneumonitis, or pulmonary fibrosis.
- Have an active autoimmune disease or a history of such conditions.
- Have previously been treated with certain immune-targeting drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Arizona | 85054 | Phoenix | Arizona |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Rocky Mountain Cancer Centers, LLP | 80124 | Lone Tree | Colorado |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| The Ohio State University Comprehensive Cancer Center | 43221 | Columbus | Ohio |
| Baylor Scott & White Medical Center | 76508 | Temple | Texas |
| Blue Ridge Cancer Care | 24153 | Salem | Virginia |
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