Table of contents
- Trial overview
- Who is being studied
- Trial design and treatment comparison
- Main outcome being measured
- What these results may mean
Trial overview
The available study is titled An Early Phase Clinical Trial to Evaluate COM701 in Relapsed Platinum Sensitive Ovarian Cancer (PSOC), and it is an interventional trial in Phase 1.[1] It is listed as authorised and plans to enroll 60 participants.[1]
This trial is studying HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST PVRIG in people with relapsed platinum sensitive ovarian cancer, also described as recurrent ovarian cancer.[1]
Who is being studied
The target population is people with relapsed platinum sensitive ovarian cancer.[1] “Relapsed” means the cancer has come back after treatment, and “platinum sensitive” means the cancer had responded before to platinum-based treatment.[1]
The trial summary also uses the term recurrent ovarian cancer, which means ovarian cancer that returns after treatment.[1] The source data does not list detailed eligibility rules such as age limits or lab test requirements.[1]
Trial design and treatment comparison
This is a single-agent study, meaning the trial is looking at HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST PVRIG by itself rather than as part of a combination regimen.[1] The brief summary says it is being studied as a maintenance regimen in participants with relapsed PSOC.[1]
The intervention list shows two study arms or treatment options: HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST PVRIG given by intravenous infusion, and saline given by intravenous infusion as the placebo comparison.[1] A placebo is a look-alike treatment used to help compare results fairly.[1]
Main outcome being measured
The primary outcome is progression free survival assessed by the investigator using RECIST 1.1 in participants treated with HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST PVRIG compared with placebo.[1] Progression free survival means the length of time the cancer does not get worse.[1]
RECIST 1.1 is a standard method doctors use to measure whether a tumor is shrinking, staying the same, or growing.[1] This outcome shows that the study is focused on whether the treatment can help delay cancer growth, not only on whether people can take the treatment safely.[1]
What these results may mean
Because this is an early phase trial, the main goal is to learn more about the treatment in people with relapsed ovarian cancer before larger studies are done.[1] The study design suggests that researchers want to see whether the treatment may help as maintenance therapy after prior treatment has worked for a time.[1]
At this stage, the available trial data do not show final results.[1] The current information mainly tells us who is being studied, how the treatment is being compared, and which outcome matters most in this trial.[1]
