MK-3475-051 pembrolizumab (melanoma, solid tumor, lymphoma)

Clinical study with the study drug MK-3475 in children with skin cancer (melanoma), solid (solid) tumor or lymphoma (lymphoma).

Recruiting

Who can enter

Children with advanced skin cancer (melanoma), solid tumor or lymphoma in whom the disease has recurred (relapse)
Age: 6 months to 17 years

Goal

In this study, we will evaluate how safe the study drug MK-3475 (pembrolizumab) is for the treatment of melanoma, solid tumors or lymphoma in children from 6 months to 17 years of age. We will also observe whether the study drug is well tolerated and how it works.
Also, we measure what happens to the study drug in the body, and determine how treatment with the study drug helps fight the disease.

Background

More research is needed on cancer treatment for children and adolescents. Often there are not many drugs available yet, or the drugs are only approved for adults.

This study uses MK-3475 (pembrolizumab) as a potential treatment for melanoma, solid tumors and lymphoma in children between the ages of 6 months and 17 years. Pembrolizumab, also known as KEYTRUDA®, can be given by doctors for several types of cancer but not yet to children for the types of cancer studied here. It is therefore called a study drug in this study.

Pembrolizumab is an immunotherapy that helps the immune system fight cancer cells. Pembrolizumab has already been approved for many different types of cancer and also for certain types of cancer in children. But not yet for all types of cancer, and not yet for children of all ages. Therefore, in this study, pembrolizumab is given to children and adolescents with different types of cancer.

In order to participate in a study please refer to your/your child’s doctor.
For international patients: please feel welcome to contact our International Patients Office.

Last reviewed

March 23, 2026

Study details
Official title
A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)
Cancer type
- Melanoma
- Solid tumor
- Lymphoma
Phase
1/2
Maximum number of patients
320, of whom 3 are expected to participate in the Netherlands
Start date
September 19, 2023
Status
Open
Local principal investigator
Dr. N.K.A van Eijkelenburg
Sponsor
Merck, Sharp & Dohme
Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.
Trial registry number
ClinialTrials.gov: NCT02332668
After the study, you can find a summary of the results in plain language on the EU websites (EU Clinical Trials Register). You can then find the study by searching for MK3475-051 or 2022-501257-36.