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
Phase 2
144
about 2.9 years
18+
9 sites in AZ, CA, CO +5
What this study is about
Researchers are testing the safety and effectiveness of two different doses of ONO-4578 combined with Opdivo®, mFOLFOX6, and bevacizumab compared to standard treatment for advanced colorectal cancer. The trial will last about 10 months.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take 5-Fluorouracil
- 2.Take Bevacizumab
- 3.Take Leucovorin
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells), bevacizumab, Antidotes, Deterrents, and Toxicologic Agents (Enzyme Interactions), immunotherapy (PD-1 inhibitor immunotherapy (nivolumab)), oxaliplatin
infusion, injection (Injection)
Primary: Number of participants with Adverse Events (AEs), Number of participants with Serious Adverse Events (SAEs), Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)
Secondary: Best overall response (BOR) by BICR, Best overall response (BOR) by Investigator assessment, Disease Control Rate (DCR) by BICR, Disease Control Rate (DCR) by Investigator assessment, Duration of response (DOR) by BICR, Duration of response (DOR) by Investigator assessment, Overall Response Rate (ORR) per Investigator assessment, Overall Survival (OS)
Oncology