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

Official Title

A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumour or Lymphoma (KEYNOTE-051)

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 tumour 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 tumours (6 months 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 tumour or other lymphoma; advanced, relapsed or refractory MSI-H solid tumour; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. With Amendment 8, enrollment of participants with solid tumours 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 solid tumours also continues.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) per Site Assessment (Melanoma, Solid Tumour and Lymphoma Participants)
• Number of Participants with Dose-Limiting Toxicities (DLTs)
• Number of Participants Experiencing Adverse Events (AEs)
• Number of Participants Discontinuing Study Drug Due to AEs
• ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per Blinded Independent Central Radiology Assessment (rrcHL Participants)

• ORR by IWG Response Criteria (Cheson, 2007) per Site Assessment (rrcHL Participants)
• Area Under the Concentration Curve (AUC) for Pembrolizumab

View this trial on ClinicalTrials.gov