A Phase I/II Study of MK-3475 (Pembrolizumab) in Children with advanced melanoma or a PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma (KEYNOTE-051)

Study of Investigational Medication for Children with Cancer

Recruiting
1 years - 17 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, pembrolizumab (MK-3475), to look for the highest dose of pembrolizumab that can be given safely without serious side effects, to find out how pembrolizumab is absorbed and broken down, and to determine how treatment with pembrolizumab may benefit your cancer.

Detailed description of study

The purpose of this study is to define the rate of dose-limiting toxicities (DLTs) at the maximum tolerated dose (MTD) or maximum administered dose (MAD) of pembrolizumab when administered as monotherapy to children from 6 months to

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: solid tumor,tumor,melanoma,malignant melanoma,skin cancer,cancer,oncology,advanced melanoma,lymphoma,refractory,relapsed,pediatric,riley,childhood,child,children,kid,kids,teen,teens,teenager,teenager,youth,adolescent
  • Age: 1 years - 17 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Between 6 months and less than 18 years of age on day of signing informed consent/assent (the first 3 participants dosed in Part 1 are to be >= 6 years of age)
  • Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1603214296 (PHO-PRADHAN-MERK-ADVL1621)

This study investigates an investigational medication to understand its safety, tolerability, and effects on tumors in children with cancer. The purpose is to determine the highest dose that can be given safely without causing serious side effects. The study will also examine how the medication is absorbed and broken down in the body, as well as its potential benefits for cancer treatment.

Participants will receive the investigational medication as a monotherapy. The study will monitor dose-limiting toxicities, which are side effects that prevent an increase in dosage. The goal is to establish the maximum tolerated dose or maximum administered dose.

  • Who can participate: Children aged 6 months to less than 18 years with advanced or metastatic solid tumors or lymphoma can participate. They must have a condition that is incurable, has failed standard treatment, or lacks a standard treatment option.
  • Study details: Participants will receive an investigational medication. The study will focus on monitoring safety and determining the appropriate dosage.

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