Table of contents
- Trial overview
- Who can participate
- What is being studied
- Study phase and design
- Main endpoints
- Trial status and size
Trial overview
The available study is an interventional trial, which means researchers give study treatment and then measure what happens.[1] It is looking at 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 the setting of advanced colorectal cancer, with a focus on patients who are PD-L1 positive.[1]
Who can participate
The trial is for participants with PD-L1 positive advanced colorectal cancer.[1] The source data do not give more detailed inclusion or exclusion rules, so the main known target group is this specific cancer population.[1]
What is being studied
The study evaluates two dose levels of ONO-4578 with Opdivo, together with standard of care, and compares this approach with standard of care alone.[1] The brief summary says the goals are to assess both safety and tolerability and efficacy, meaning whether the treatment can be given safely and whether it may help control the cancer.[1]
The treatment list also includes bevacizumab, calcium folinate, oxaliplatin, fluorouracil, and Opdivo, showing that the study uses a combination treatment approach.[1] The source data do not explain the role of each medicine in detail, so the key point is that the trial compares a study regimen with usual care in this cancer type.[1]
Study phase and design
This is a Phase 2 trial.[1] Phase 2 studies are usually done after early testing and are designed to look more closely at whether a treatment seems promising in a specific group of patients.[1]
The study is listed as authorised, which means it has been approved to proceed in the source registry.[1] The planned enrollment is 144 people, so the study is relatively small and focused on a defined patient group.[1]
Main endpoints
The primary outcomes include the incidence and severity of adverse events and serious adverse events.[1] These measures help researchers understand how often unwanted medical problems happen and how serious they are.[1]
Other main outcomes are dose interruptions, dose reductions, and drug discontinuations because of treatment-emergent side effects.[1] This tells the team whether side effects are strong enough to change or stop treatment.[1]
The study also measures overall response rate by blinded independent central review using RECIST v1.1.[1] In simple terms, this checks how many patients have a measurable tumor response, using a standard method and reviewers who do not know which treatment was given.[1]
Trial status and size
The trial status is Authorised and the planned enrollment is 144 participants.[1] Based on the available data, this is the only trial provided for this substance, and it focuses on one disease setting: PD-L1 positive advanced colorectal cancer.[1]
