Study of Pembrolizumab for Children with Advanced Melanoma or PD-L1 Positive Solid Tumors and Lymphoma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called pembrolizumab, also known by its code name MK-3475, in children with certain types of cancer. The cancers being studied include advanced melanoma, which is a serious form of skin cancer, and other solid tumors or lymphomas that have either returned after treatment or are not responding to existing treatments. The study also includes children with tumors that have specific characteristics, such as being PD-L1 positive or having a high number of genetic mutations, known as tumor mutational burden-high (TMB-H).

The purpose of the study is to understand how safe and tolerable pembrolizumab is for children and to see how well it works against these cancers. Pembrolizumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The study will monitor the children for any side effects and measure how their tumors respond to the treatment. Some children in the study may receive a placebo, which is a substance with no active medication, to compare the effects of pembrolizumab.

Participants in the study will receive regular assessments to track their health and the progress of their cancer. These assessments will help researchers determine the effectiveness of pembrolizumab in shrinking or controlling the tumors. The study aims to provide valuable information that could lead to better treatment options for children with these challenging types of cancer.

1 joining the study

Upon joining the study, participants will be required to sign an informed consent form. This document confirms understanding of the study and agreement to participate.

Participants must meet specific criteria, such as being between 6 months and less than 18 years old, and having a type of cancer that is advanced, relapsed, or refractory.

2 initial assessments

Before starting the treatment, participants will undergo various assessments to ensure eligibility. These may include medical history review, physical examination, and laboratory tests to check organ function.

Female participants of childbearing potential will need to take a pregnancy test within 72 hours before the first dose of the study medication.

3 treatment administration

Participants will receive the study medication, pembrolizumab, which is administered as a solution for infusion. This means the medication is given directly into a vein through an intravenous (IV) line.

The dosage and frequency of administration will be determined by the study protocol and the participant’s specific condition.

4 ongoing monitoring

Throughout the study, participants will be regularly monitored for any side effects or adverse events. This includes routine check-ups and laboratory tests.

The study aims to evaluate the safety and effectiveness of pembrolizumab in treating the specific types of cancer involved in the trial.

5 response evaluation

Participants will undergo assessments to evaluate the response of their cancer to the treatment. This may involve imaging tests and other evaluations based on specific criteria.

The study will assess the antitumor activity of pembrolizumab using established response evaluation criteria.

6 completion of study

At the end of the study period, participants will have a final evaluation to assess their overall health and the outcomes of the treatment.

Participants may be asked to continue follow-up visits to monitor long-term effects and gather additional data.

Who Can Join the Study?

  • Participants must be between 6 months and less than 18 years old on the day they sign the consent form.
  • Female participants who can have children must have a negative pregnancy test within 72 hours before the first dose of the study medication.
  • Female participants who can have children must either not be sexually active or use birth control during the study and for at least 120 days after the last dose of the study medication.
  • Male participants must use birth control methods that follow local regulations for clinical studies.
  • Participants must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • Participants must have a type of cancer that is advanced or has spread and cannot be cured, or for which no standard treatment exists or is suitable.
  • Participants can have had any number of previous treatments.
  • Participants must have a sample of their tumor available, either from a previous biopsy or a new one if needed.
  • Participants must have advanced melanoma or a PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma. PD-L1-positive means the tumor has a protein that may respond to certain treatments.
  • Participants must have a measurable disease based on specific criteria, meaning the cancer can be measured in size.
  • Participants with neuroblastoma that can be seen with a special scan called MIBG may join the study. Neuroblastoma is a type of cancer, and MIBG is a scan used to detect it.
  • Participants must have a score of 50 or higher on the Lansky Play Scale if they are between 6 months and 16 years old, or a Karnofsky score of 50 or higher if they are older than 16. These scores measure how well they can perform daily activities.
  • Participants must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than those specified in the study.
  • Patients who are not between 6 months and less than 18 years old.
  • Patients with tumors that do not have a high number of mutations, except for certain types of tumors.
  • Patients with tumors that have a specific genetic feature called MSI-H or dMMR are excluded, except for certain conditions.
  • Patients who have not relapsed or whose cancer is not resistant to treatment.
  • Patients who are not able to tolerate the study medication.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are not able to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Assistance Publique Hopitaux De Paris Paris France
Justus-Liebig-Universitaet Giessen Giessen Germany
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Agnzurr Obyamaccknr Uyxnpwacplrce Cghvfuynuqcw Dzhle Sjwukq E Dxxrr Sqzqthv Dg Tydxqy Turin Italy
Uwaajxtghhavrvxhxdkhq Mdtqjvvq Aew Munster Germany
Cnfjaa Ljxe Bqyruv Lyon France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
16.01.2023
Germany Germany
Recruiting
16.01.2023
Italy Italy
Recruiting
16.01.2023
Portugal Portugal
Not recruiting
16.01.2023
Sweden Sweden
Recruiting
16.01.2023
The Netherlands The Netherlands
Not recruiting
16.01.2023

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer. Pembrolizumab targets a specific protein on the surface of certain immune cells, which can help your body recognize and attack cancer cells more effectively. In this clinical trial, pembrolizumab is being tested to see how safe it is for children with advanced melanoma or other types of tumors that have come back or are difficult to treat. The study aims to find out how well pembrolizumab works in shrinking these tumors and what side effects it might cause.

Advanced Melanoma – Advanced melanoma is a type of skin cancer that has spread beyond the original site to other parts of the body. It begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can invade nearby tissues and organs, making it more challenging to manage. The spread of melanoma to distant organs is known as metastasis, which can affect the lungs, liver, brain, and bones. The progression of advanced melanoma can vary, with some cases spreading rapidly while others may progress more slowly.

PD-L1 Positive Malignant Solid Tumor – PD-L1 positive malignant solid tumors are characterized by the expression of the PD-L1 protein on the surface of cancer cells. This protein can help tumors evade the immune system by inhibiting the activity of immune cells. These tumors can occur in various organs and tissues, leading to a range of symptoms depending on their location. As the disease progresses, the tumor may grow and spread to other parts of the body, a process known as metastasis. The presence of PD-L1 can influence the tumor’s behavior and its interaction with the immune system.

Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) – Classical Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, specifically affecting a type of white blood cell called lymphocytes. In relapsed or refractory cases, the disease returns after treatment or does not respond to standard therapies. The progression involves the growth of abnormal lymphocytes, which can form tumors in lymph nodes and other parts of the body. As the disease advances, it can impair the immune system’s ability to function properly. The spread of lymphoma can lead to symptoms such as swollen lymph nodes, fever, and weight loss.

Microsatellite Instability-High (MSI-H) Solid Tumors – MSI-H solid tumors are characterized by a high level of genetic mutations due to defects in the DNA mismatch repair system. These tumors can occur in various organs, including the colon, stomach, and endometrium. The progression of MSI-H tumors involves the accumulation of genetic errors, which can lead to uncontrolled cell growth and tumor development. As the disease advances, these tumors may invade surrounding tissues and metastasize to distant sites. The high mutation rate in MSI-H tumors can influence their behavior and response to the immune system.

Tumor Mutational Burden-High (TMB-H) Solid Tumors – TMB-H solid tumors are defined by a high number of mutations within the tumor’s DNA. These mutations can lead to the production of abnormal proteins that may be recognized by the immune system. TMB-H tumors can develop in various tissues and organs, leading to diverse clinical presentations. As the disease progresses, the tumor may grow and spread to other parts of the body, a process known as metastasis. The high mutational burden can affect the tumor’s characteristics and its interaction with the immune system.

Trial ID:
2022-501257-36-00
Protocol code:
MK3475-051
Trial Phase:
Human Pharmacology (Phase I) – Other

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