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

Complete Title: SC-4005: 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)
Trial Phase: I/II
Investigator: Navin Pinto

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), or advanced relapsed or refractory tumor-mutational burden-high =10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years 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. The 10% assessment does not apply to the MSI-H and TMB-H cohorts. 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 and TMB-H solid tumors also continues.

Keywords:
  • Hematologic Malignancies
  • Lymphoma
  • Lymphoproliferative Disorders
  • Melanoma
  • Pediatric Cancers, Miscellaneous
  • Sarcoma
  • Solid Tumors
  • Neoplasms, Germ Cell and Embryonal
  • Neuroendocrine Tumor
  • Neoplasms
  • Immunoproliferative Disorders
  • Neuroectodermal Tumors
  • Neoplasms, Nerve Tissue
  • Immune System Diseases
  • Immunotherapy
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Pediatric
I/II
Navin Pinto
SC-4005
NCT02332668
SC-4005: 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)
Hematologic Malignancies
Lymphoma
Lymphoproliferative Disorders
Melanoma
Pediatric Cancers, Miscellaneous
Sarcoma
Solid Tumors
Neoplasms, Germ Cell and Embryonal
Neuroendocrine Tumor
Neoplasms
Immunoproliferative Disorders
Neuroectodermal Tumors
Neoplasms, Nerve Tissue
Immune System Diseases
Immunotherapy