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)
SC_4005_Merck
What is the goal of the study?
Primary Objectives Part I: (1) To define the rate of dose-limiting toxicities (DLTs) at the maximum tolerated dose (MTD) or maximum administered dose (MAD) of pembrolizumab when administered as monotherapy to children from 6 months to < 18 years of age pooled across all indications including advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma. (2) To characterize the pharmacokinetics (PK) of pembrolizumab when administered as monotherapy to children from 6 months to < 18 years of age pooled across all indications including advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma. Parts I and II: (1) To determine the safety and tolerability of pembrolizumab based on AEs, and clinical and laboratory measures in children from 6 months to <18 years of age pooled across all indications including advanced melanoma or a pd-l1 positive advanced, relapsed or refractory solid tumor or lymphoma. (2) to evaluate anti-tumor activity of pembrolizumab in children from 6 months to><18 years of age within each tumor type including advanced melanoma or a pdl1 positive advanced, relapsed or refractory solid tumor or lymphoma based on recist 1.1.>
Who can participate in the study?
Please contact the study team listed below to learn more.