Last updated on July 2019

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)


Brief description of study

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer:

  • advanced melanoma (6 months to <18 years of age),
  • advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),
  • relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or
  • advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age).

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.

The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer.

With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged 12 years to 18 years with melanoma continues. Enrollment of participants with MSI-H solid tumors also continues.

Clinical Study Identifier: NCT02332668

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