Femme et Homme
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Extrait
(1) Objective: 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) Objective: 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 (3) Objective: 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 (4) Objective: To evaluate anti-tumor activity of pembrolizumab in children from 6 months to <18 years of age within each tumor type based on RECIST 1.1.
Critère d'inclusion
- Treatment of advanced melanoma or advanced, relapsed or refractory PD-L1 positive malignant solid tumor or lymphoma in children from 6 months to less than 18 years old