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Tucidinostat

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.

Table of Contents

Trial overview

NCT04674683 is an interventional Phase 3 study in people with metastatic or unresectable melanoma.[1] The trial status is Authorised, and the planned enrollment is 325 participants.[1]

This study is looking at Tucidinostat as part of a treatment plan for a serious form of skin cancer.[1] 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.[1]

Who can participate

The trial is for patients with metastatic melanoma or unresectable melanoma.[1] Metastatic means the cancer has spread to other parts of the body, and unresectable means it cannot be removed with surgery.[1]

The source data does not list other eligibility details, such as age limits, test results, or previous treatments.[1]

Treatments being tested

The study compares two treatment arms.[1] The test arm uses Tucidinostat with nivolumab, and the control arm uses placebo with nivolumab.[1]

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.[1] The study summary also describes the comparison as HBI-8000 plus nivolumab versus placebo plus nivolumab.[1]

Study phase and design

This is a randomized study, which means participants are assigned to a treatment group by chance.[1] Randomization helps make the two groups more similar so the results are easier to compare.[1]

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.[1] In this study, the comparison is against placebo plus nivolumab.[1]

Outcomes being measured

The primary endpoint is progression-free survival (PFS).[1] PFS is defined as the time from randomization to the first documented disease progression, or death from any cause, whichever happens first.[1]

Disease progression is assessed using RECIST 1.1, a standard way to measure whether tumors have grown, shrunk, or stayed the same.[1] The progression event is determined by BIRC, an independent review group that checks the study results in a neutral way.[1]

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.[1] The main result the researchers will watch is how long people stay free from progression or death.[1]

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.[1] The trial record provided does not include other outcomes beyond PFS.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04674683 Phase 3 Metastatic or unresectable melanoma Authorised 325

FAQ

  • What is being studied in the Tucidinostat trial? The trial is studying Tucidinostat together with nivolumab in people with metastatic or unresectable melanoma. It compares this treatment with a control arm that uses placebo plus nivolumab.
  • Who can take part in this trial? The study is for patients with metastatic or unresectable melanoma. This means the cancer has spread or cannot be removed with surgery.
  • What phase is the Tucidinostat study? This is a Phase 3 trial. Phase 3 studies usually compare treatments in larger groups of patients to see how well they work.
  • What is the main goal of the trial? The main goal is to measure progression-free survival, often called PFS. This is the time from randomization until the cancer gets worse or the patient dies from any cause.
  • How many people are planned for the study? The trial plans to enroll 325 people. This gives the study enough participants to compare the two treatment groups.

Ongoing Clinical Trials on Tucidinostat

  • Study of Tucidinostat and Nivolumab for Patients with Advanced Melanoma Not Treated with PD-1 or PD-L1 Inhibitors

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia France Germany Italy Spain

Glossary

  • Metastatic melanoma: Melanoma, a type of skin cancer, that has spread to other parts of the body.
  • Unresectable: Not able to be removed by surgery.
  • Phase 3: A later stage of clinical research that compares treatments in larger groups of people.
  • Interventional study: A study where researchers give a treatment and measure the results.
  • Randomization: A method of assigning participants to different treatment groups by chance.
  • Placebo: An inactive treatment used for comparison in a study.
  • Nivolumab: A treatment used in the study as part of both the test and control arms.
  • Progression-free survival (PFS): The length of time after randomization before the cancer gets worse or the patient dies.
  • RECIST 1.1: A standard way to measure whether a tumor has grown, shrunk, or stayed the same.
  • BIRC: An independent group that checks study results in a neutral way.

References