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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fondazione Luigi Maria Monti	Rome	Italy
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
HELIOS Klinikum Erfurt GmbH	Erfurt	Germany
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
MD Anderson Cancer Center	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hopital Ambroise Pare	Boulogne-Billancourt	France
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
University Hospital Olomouc	Olomouc	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
University Hospital Ostrava	Ostrava	Czechia
Cssbucynb Uyrgilcwkepkeb Simyxztws	Woluwe-Saint-Lambert	Belgium
Iihbkpvt Cdquml Dhuqhgheqhmnzvwod	L'hospitalet De Llobregat	Spain
Ckb Dvhcd Bewsagwrm Hnmsksu Fuuygdmp Mitxfwzba	Dijon	France
Hyrymrwn Unojbjxfyhowvb dx Mdpbthcea Trcelv	Marseille	France
Ujcvdqdzyb Htabodiy Cxpdlmp	Cologne	Germany
Agdosutott Pmuenunx Hjrsglvs Dv Pytsc	Paris	France
Bczjfpru Usfpitnxpr Hgiekjnk Cqifig	Besançon	France
Aocelib Ovcjwjbkfhj Uehqftegypwvw Scyzur	Siena	Italy
Kwobyfhn dgu Uztwzmyavwfv Mcsmolrs Aod	Munich	Germany
Hofofnfz Da Ll Shndo Cpyz I Semq Pem	Barcelona	Spain
Hmeyvihd Urhkajwvhoips Hcienhtm Tncmp y Ppezna Ijfarbwm Ciqgjk dyuyeckpngnxflvks (wfrq	Badalona	Spain
Hnlwhikq Vsjy djtqtugw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2021
Czechia	Not recruiting	01.09.2021
France	Not recruiting	01.09.2021
Germany	Not recruiting	01.09.2021
Italy	Not recruiting	01.09.2021
Spain	Not recruiting	01.09.2021

Trial locations

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.

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 ID:

2024-516914-39-00

Protocol code:

HBI-8000-303

NCT ID:

NCT04674683

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?