Table of contents
- Trial overview
- Who the study is for
- What treatment is being tested
- What the study measures
- Study phase and size
- What these results may mean for patients
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.[1] The study is designed to compare two dose levels of ONO-4578 with Opdivo plus standard of care against standard of care alone.[1]
The trial is interventional, which means researchers assign the study treatment rather than only observing care already being given.[1] Its status is Authorised and it is in Phase 2.[1]
Who the study is for
The target population is participants with PD-L1 positive advanced colorectal cancer.[1] 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.[1]
The source data does not list other entry rules, such as age limits, prior treatments, or laboratory requirements.[1] Because of that, the clearest known eligibility details are the cancer type and biomarker status.[1]
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.[1] The listed treatment plan also includes calcium folinate, oxaliplatin, and fluorouracil as part of the standard regimen.[1]
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.[1] 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.[1]
What the study measures
The main safety measures are the incidence and severity of adverse events and serious adverse events.[1] Adverse events are medical problems that happen during the trial, and serious adverse events are the more severe ones.[1]
The trial also measures dose interruptions, dose reductions, and drug discontinuations caused by treatment-emergent adverse events.[1] These measures show how often treatment has to be paused, lowered, or stopped because of side effects that appear during the study.[1]
For effectiveness, the trial measures overall response rate by blinded independent central review using RECIST v1.1.[1] This means independent reviewers check scans using a standard rule set to see how many participants have a tumor response.[1]
Study phase and size
This is a Phase 2 study with a planned enrollment of 144 participants.[1] Phase 2 trials are commonly used to look more closely at early evidence of benefit while continuing to monitor safety.[1]
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.[1]
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.[1] The study aims to learn whether adding the trial treatment to standard care may be safe and may improve tumor response.[1]
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.[1]
