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Trial Summary


Protocol No.PHO-PRADHAN-MERK-ADVL1621
StatusSUSPENDED
Principal InvestigatorFerguson, Michael
ScopeNational
PhasePhase I/II
Age GroupChildren
TitleA 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)
DescriptionThis is a 2-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma or a programmed cell death ligand 1 (PD-L1)-positive advanced, relapsed or refractory solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.
Key EligibilityIn 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.
Applicable Disease SitesAny Site
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactAngie L. Myers, RNPhone: +1 317-948-8540
    Pager: +1 317-312-1209
    Email: almyers2@iu.edu