Summary
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 â?¥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 â?¥12 years
to â?¤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H
solid tumors also continues.