In short
Clinical trials are investigating 4-[4-CYANO-2-[[(1'R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2'-CYCLOPROPANE]-1'-CARBONYL]AMINO]PHENYL]BUTANOIC ACID in people with PD-L1 positive advanced colorectal cancer. The study looks at safety, tolerability, and how well the treatment works compared with standard care. It is a Phase 2 trial in adults with non MSI-H/dMMR disease.
Key points
- Clinical trials are studying 4-[4-CYANO-2-[[(1'R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2'-CYCLOPROPANE]-1'-CARBONYL]AMINO]PHENYL]BUTANOIC ACID in PD-L1 positive advanced colorectal cancer. The trial is Phase 2 and is authorised. It includes adults with non MSI-H/dMMR disease and plans to enroll 144 participants. The study compares two dose levels with Opdivo plus standard of care against standard of care alone. Main goals are to check safety, tolerability, and early signs of effectiveness, including overall response rate.
Trial overview
This clinical trial is studying 4-[4-CYANO-2-[[(1'R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2'-CYCLOPROPANE]-1'-CARBONYL]AMINO]PHENYL]BUTANOIC ACID in people with PD-L1 positive advanced colorectal cancer. The study is designed to compare two dose levels of ONO-4578 with Opdivo plus standard of care against standard of care alone.
The trial is interventional, which means researchers assign the study treatment rather than only observing care already being given. Its status is Authorised and it is in Phase 2.
Who the study is for
The target population is participants with PD-L1 positive advanced colorectal cancer. The trial also specifies non MSI-H/dMMR disease, meaning the cancer does not have high microsatellite instability and does not have deficient mismatch repair.
The source data does not list other entry rules, such as age limits, prior treatments, or laboratory requirements. Because of that, the clearest known eligibility details are the cancer type and biomarker status.
What treatment is being tested
The study compares ONO-4578 with Opdivo together with standard treatment, which includes mFOLFOX6 and bevacizumab, against standard care alone. The listed treatment plan also includes calcium folinate, oxaliplatin, and fluorouracil as part of the standard regimen.
In simple terms, the trial is asking whether adding the study treatment to usual care may improve results for people with this type of colorectal cancer. The trial summary says it is looking at both safety and efficacy, which means whether the treatment can be used safely and whether it may help control the cancer better.
What the study measures
The main safety measures are the incidence and severity of adverse events and serious adverse events. Adverse events are medical problems that happen during the trial, and serious adverse events are the more severe ones.
The trial also measures dose interruptions, dose reductions, and drug discontinuations caused by treatment-emergent adverse events. These measures show how often treatment has to be paused, lowered, or stopped because of side effects that appear during the study.
For effectiveness, the trial measures overall response rate by blinded independent central review using RECIST v1.1. This means independent reviewers check scans using a standard rule set to see how many participants have a tumor response.
Study phase and size
This is a Phase 2 study with a planned enrollment of 144 participants. Phase 2 trials are commonly used to look more closely at early evidence of benefit while continuing to monitor safety.
Because only one trial is provided in the source data, the overall picture is focused on this single Phase 2 study in advanced colorectal cancer.
What these results may mean for patients
For patients, this trial is important because it studies a specific group: people with PD-L1 positive advanced colorectal cancer that is non MSI-H/dMMR. The study aims to learn whether adding the trial treatment to standard care may be safe and may improve tumor response.
The current data does not report trial results yet, so the focus is on what the study is designed to test rather than on outcomes already proven.