In short
Clinical trials are studying Tucidinostat in people with metastatic or unresectable melanoma, a serious skin cancer that cannot be removed by surgery or has spread. These studies are mainly looking at whether Tucidinostat-based treatment can improve outcomes such as progression-free survival and how it compares with control treatment.
Key points
- One clinical trial is studying Tucidinostat in people with metastatic or unresectable melanoma. It is a Phase 3 study, which means it is testing the treatment in a larger group of patients. The study compares Tucidinostat plus nivolumab with placebo plus nivolumab. The main outcome is progression-free survival, which measures how long patients live without the cancer getting worse. The planned enrollment is 325 people.
Trial overview
NCT04674683 is an interventional Phase 3 study in people with metastatic or unresectable melanoma. The trial status is Authorised, and the planned enrollment is 325 participants.
This study is looking at Tucidinostat as part of a treatment plan for a serious form of skin cancer. The trial is focused on whether the study treatment can improve progression-free survival, which means the time before the cancer gets worse or the patient dies.
Who can participate
The trial is for patients with metastatic melanoma or unresectable melanoma. Metastatic means the cancer has spread to other parts of the body, and unresectable means it cannot be removed with surgery.
The source data does not list other eligibility details, such as age limits, test results, or previous treatments.
Treatments being tested
The study compares two treatment arms. The test arm uses Tucidinostat with nivolumab, and the control arm uses placebo with nivolumab.
In the trial record, nivolumab is listed as OPDIVO 10 mg/mL concentrate for solution for infusion, given by infusion, while Tucidinostat is listed as an oral drug. The study summary also describes the comparison as HBI-8000 plus nivolumab versus placebo plus nivolumab.
Study phase and design
This is a randomized study, which means participants are assigned to a treatment group by chance. Randomization helps make the two groups more similar so the results are easier to compare.
The trial is in Phase 3, which usually means the treatment is being tested in a larger group and compared against another treatment or placebo. In this study, the comparison is against placebo plus nivolumab.
Outcomes being measured
The primary endpoint is progression-free survival (PFS). PFS is defined as the time from randomization to the first documented disease progression, or death from any cause, whichever happens first.
Disease progression is assessed using RECIST 1.1, a standard way to measure whether tumors have grown, shrunk, or stayed the same. The progression event is determined by BIRC, an independent review group that checks the study results in a neutral way.
What this means for patients
For patients, this trial is testing whether adding Tucidinostat to nivolumab may help keep metastatic or unresectable melanoma from getting worse for longer. The main result the researchers will watch is how long people stay free from progression or death.
Because the study is in Phase 3 and includes 325 participants, it is designed to give a more reliable comparison between the study treatment and the control treatment. The trial record provided does not include other outcomes beyond PFS.