Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of skin cancer known as melanoma, specifically cases that cannot be surgically removed or have spread to other parts of the body. The study is testing a combination of two treatments: Tucidinostat (also known by its code name HBI-8000) and Nivolumab (marketed as Opdivo). These treatments will be compared to a combination of a placebo and Nivolumab. The purpose of the study is to see how well these treatments work in preventing the cancer from getting worse.

Participants in the study will be randomly assigned to receive either the combination of Tucidinostat and Nivolumab or the placebo and Nivolumab. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The study will last for a period of up to 24 months, during which participants will receive regular check-ups and monitoring to assess the progress of their condition.

The main goal is to measure how long patients live without their cancer worsening, known as progression-free survival. Other important outcomes include the overall response to the treatment and the overall survival of the participants. This study aims to provide valuable information on the effectiveness of combining Tucidinostat with Nivolumab in treating advanced melanoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of tucidinostat and nivolumab, while the other group will receive a placebo with nivolumab. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Treatment administration

    If you are in the group receiving tucidinostat, you will take it in the form of a coated tablet by mouth. The dosage and frequency will be determined by the study team.

    All participants will receive nivolumab as a solution for infusion. This means it will be administered through a vein, typically in a hospital or clinic setting. The dosage and frequency will be specified by the study team.

  3. Step 3

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments may include physical exams, blood tests, and imaging tests such as CT scans.

    The purpose of these assessments is to evaluate the progression of the melanoma and to ensure your safety during the trial.

  4. Step 4

    Progression-free survival evaluation

    The main goal of the study is to measure progression-free survival, which is the time from the start of the treatment until the melanoma progresses or you experience any cause of death.

    This evaluation will be based on the results of your regular assessments and will help determine the effectiveness of the treatment.

  5. Step 5

    Completion of study

    The study is expected to continue until March 2026. Your participation may end earlier if the melanoma progresses, if you experience significant side effects, or if you choose to withdraw from the study.

    Upon completion, you will have a final assessment to evaluate your overall health and the outcomes of the treatment.

Who can join the trial?

15 criteria

  • Must have a confirmed diagnosis of non-uveal, Stage III (unresectable) or Stage IV (metastatic) melanoma. This means the melanoma cannot be removed by surgery or has spread to other parts of the body.
  • Women who can have children must have a negative pregnancy test at the start of the study.
  • Women who can become pregnant and all men must agree to use a reliable method of birth control during the study and for 5 months after the last dose of the study drug. This is to prevent pregnancy due to potential drug exposure.
  • Must be able to understand and agree to sign a consent form, and be willing to follow the study schedule and procedures.
  • Must know their BRAF V600 mutation status or agree to be tested for it before starting the study. This is a specific genetic change that can occur in melanoma.
  • Must have tumor tissue available for PD-L1 testing. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • Must be 12 years of age or older.
  • Must have a good performance status, which means being well enough to carry out daily activities. For those 18 and older, this is measured by the ECOG performance status of 0 or 1. For ages 12-17, it is measured by the Lansky performance status of 80% or higher.
  • Must have at least one measurable tumor that can be seen and measured on a scan, separate from the tumor used for PD-L1 testing.
  • Must not have received certain treatments for melanoma, like anti-PD-1 or anti-PD-L1 therapies, unless specific conditions are met, such as recovery from previous treatment side effects.
  • Any previous radiation therapy or minor surgery must be completed at least 2 weeks and 1 week before starting the study treatment, respectively, and any side effects must have resolved.
  • Must have certain blood test results within normal ranges before starting the study, including:
    • White blood cells, neutrophils, and platelets at specific levels.
    • Kidney function measured by CrCL (creatinine clearance) of at least 30 mL/min.
    • Liver enzymes (AST and ALT) and other liver function tests within specified limits.
    • Serum albumin level of at least 3.0 g/dL.

Who cannot join the trial?

11 criteria

  • Patients with any other type of cancer that is not **metastatic or unresectable melanoma**.
  • Patients who have had a different cancer treatment within the last 4 weeks.
  • Patients with an active infection that requires treatment.
  • Patients with a known allergy to the study drugs or similar drugs.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who have received an organ transplant.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are participating in another clinical trial.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • HBI-8000

    is a medication being studied for its potential to help treat melanoma, a type of skin cancer. It is being tested in combination with another drug to see if it can improve outcomes for patients whose melanoma cannot be surgically removed or has spread to other parts of the body. The goal is to see if this combination can help slow down the progression of the disease or improve survival rates.

  • Nivolumab

    is a type of immunotherapy used to treat various cancers, including melanoma. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, nivolumab is being used in combination with another medication to see if this approach can provide better results for patients with melanoma that cannot be removed by surgery or has spread.

What is already known about the treatment

  • HBI-8000

    HBI-8000 is administered orally in the form of tablets and is currently being studied in combination with nivolumab for the treatment of metastatic or unresectable melanoma. This medication is in the clinical trial phase and is not yet widely available in medical practice. It works by modifying the activity of certain proteins in cancer cells, which can slow down or stop the growth of tumors. HBI-8000 is classified as a histone deacetylase inhibitor, a type of drug that affects gene expression in cells.

  • Nivolumab

    Nivolumab is given as an injection into a vein, typically in a hospital or clinic setting, and is used to treat various types of cancer, including metastatic or unresectable melanoma. It is an established medication in oncology and is well-documented in medical literature. Nivolumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1 on immune cells. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

Metastatic or unresectable melanoma – Metastatic melanoma is a type of skin cancer that has spread from its original site to other parts of the body. It often begins in the pigment-producing cells called melanocytes. As the disease progresses, cancer cells can travel through the lymphatic system or bloodstream to distant organs, such as the lungs, liver, brain, or bones. Unresectable melanoma refers to melanoma that cannot be removed completely through surgery, often due to its location or extent. The progression of this disease can lead to the formation of new tumors in various parts of the body. Symptoms may vary depending on where the cancer has spread, and they can include changes in the skin, such as new growths or changes in existing moles, as well as systemic symptoms like fatigue or weight loss.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516914-39-00Protocol codeHBI-8000-303Estimated enrolment325 patientsSponsorHuyabio International LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.