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)
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
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
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Age: 1 years - 17 years
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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.
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