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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
St. Anna Kinderspital GmbH Vienna Austria
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Uzkefkivhdlcqjdiinfnf Ernwi Atk Essen Germany
Udvhpqmpdklmcmjpiwriv Atzmhmtp Augsburg Germany
Iyichnst Cshut Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
26.05.2020
France France
Recruiting
26.05.2020
Germany Germany
Recruiting
26.05.2020
Sweden Sweden
Recruiting
26.05.2020
The Netherlands The Netherlands
Recruiting
26.05.2020

Trial locations

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.

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 ID:
2024-514409-78-01
Protocol code:
INFORM2-NivEnt
NCT ID:
NCT20170516
Trial Phase:
Human Pharmacology (Phase I) – Other

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