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Study of Nivolumab and Entinostat for Children and Adolescents with High-Risk Refractory or Relapsed Malignant Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying treatments for children and adolescents with difficult-to-treat cancers. These cancers are known as refractory high-risk malignancies, which means they are resistant to standard treatments and pose a high risk to the patient. The study is exploring the effects of a combination of two medications: Nivolumab and Entinostat. Nivolumab is a medication that helps the immune system recognize and attack cancer cells, while Entinostat is a drug that can modify the way cancer cells grow and divide.

The purpose of this study is to see how well the combination of Nivolumab and Entinostat works in treating these challenging cancers. The study will involve children and adolescents who have cancers with certain characteristics, such as a high number of genetic changes, specific gene amplifications, or a high presence of immune cells within the tumor. Participants will receive the study medications and be monitored for their response to the treatment over a period of time.

The study will be conducted in phases, starting with a focus on determining the safest dose of the combination treatment, followed by an assessment of how well the treatment works in shrinking or controlling the cancer. The trial aims to provide valuable information on the potential benefits of using Nivolumab and Entinostat together for treating these high-risk cancers in young patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will undergo a series of assessments to confirm eligibility. This includes laboratory tests to check blood counts and organ function, as well as a review of medical history and current health status.

    The patient must be able to swallow oral medication and meet specific health criteria, such as having a life expectancy greater than three months and a sufficient general condition score.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of two medications: entinostat and nivolumab. Entinostat is administered orally in the form of film-coated tablets, while nivolumab is given as an infusion.

    The specific dosage and frequency of administration will be determined by the study protocol and the patient's individual health needs.

  3. Step 3

    Monitoring and assessment

    Throughout the study, the patient's response to the treatment will be closely monitored. This includes regular medical check-ups, imaging tests, and laboratory evaluations to assess the effectiveness of the treatment and any potential side effects.

    The primary goal is to determine the best response to the treatment, which will be evaluated using specific criteria for tumor response.

  4. Step 4

    Completion of treatment

    The study is expected to continue until June 2026. The duration of participation for each patient may vary based on individual response to treatment and overall health condition.

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

18 criteria

  • Children and adolescents with certain types of brain tumors or solid tumors that have come back or are not responding to treatment.
  • Children and adolescents with newly diagnosed high-grade brain tumors, who have had surgery and have no other treatment options.
  • Must meet specific blood test requirements, including certain levels of blood cells and liver and kidney function.
  • Must have a normal heart rhythm as shown by an ECG test.
  • Must be able to swallow pills.
  • Must understand the trial and its consequences, or have a legal representative who does.
  • Females who can have children must have a negative pregnancy test and agree to use birth control during and after the study. Males must agree to use a condom during and after the study.
  • Must not have any conditions that would make it hard to follow the study rules.
  • Must give written consent to participate, including agreement to share data and blood samples.
  • Must not have had previous treatment with certain immune and cancer drugs.
  • Must have specific genetic tests done to know the status of certain biomarkers, which are indicators in the body that can affect how the disease behaves.
  • Must not have any standard treatment options available.
  • Must be between 2 and 21 years old.
  • Must have genetic testing done in a certified lab to identify specific biomarkers.
  • If genetic testing was not done in a specific way, the data must be shared for review.
  • The time between the last tumor sample and joining the study must be within a certain number of weeks.
  • Must have a disease that can be measured by specific medical criteria.
  • Must have a life expectancy of more than 3 months and a good general health score. Temporary conditions like infections can be accepted, as well as stable disabilities from the disease or surgery.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of disease than the one being studied cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the specific health conditions required for the study cannot participate.
  • Patients who are unable to follow the study procedures or instructions cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or medical procedure cannot participate.
  • Patients who have a history of severe allergic reactions to the study medications cannot participate.
  • Patients who have certain infections or diseases that could affect the study cannot participate.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

  • Entinostat

    is another medication used in the trial, which helps to modify the way cancer cells grow and divide. It works by interfering with certain enzymes in the cancer cells, potentially making them more susceptible to the immune system's attack.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating high-risk malignant diseases that are resistant or have returned after treatment. The main therapeutic use of Nivolumab is in cancer treatment, particularly for tumors with high mutational loads or specific genetic markers. It works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor.

  • Entinostat

    Entinostat is taken orally in tablet form. It is under investigation in clinical trials for its potential to treat high-risk malignant diseases that are difficult to treat or have recurred. The primary therapeutic indication for Entinostat is in combination with other treatments for cancer, especially those with specific genetic features. It functions by inhibiting enzymes known as histone deacetylases, which can affect gene expression and slow down cancer cell growth. Entinostat is classified as a histone deacetylase inhibitor.

Investigated diseases

Relapsed/Refractory or Progressive High-Risk Malignant Disease – This term refers to cancers that have returned after treatment (relapsed), do not respond to treatment (refractory), or continue to grow despite treatment (progressive). These diseases are considered high-risk due to their aggressive nature and potential for rapid progression. They can occur in various forms, including solid tumors and blood cancers, and may affect different parts of the body. The progression of these diseases can vary, with some growing slowly and others advancing quickly. The focus is often on understanding the underlying genetic and molecular characteristics that drive their growth and resistance to standard therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514409-78-01Protocol codeINFORM2-NivEntEstimated enrolment91 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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