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)

Contact:

NCT Number:

Protocol:

AAAQ7819

Study Status:

Active/Enrolling

Population:

Pediatrics

Phase:

I/II

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant 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. This study is being sponsored by the Children's Oncology Group and Merck Sharp & Dohme Corp. as KEYNOTE-051.

Are you Eligible? (Inclusion Criteria)

  • Subjects must be at least 6 months and up to 17 years of age at the time of study entry.
  • Patients must have one of the following types of cancer verified with pathology at original diagnosis or at relapse - a) melanoma, b) solid tumor), or c) lymphoma.
  • Patients must have disease that has either relapsed or is refractory to prior therapy or for which no standard therapy is considered appropriate.
  • Patients must also meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Childhood and Adolescent Cancers (Pediatric), Immunotherapy

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032