A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphoma
Research type
Research Study
Full 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 tumor or lymphoma (KEYNOTE-051)
IRAS ID
167317
Contact name
Lynley Marshall
Contact email
Eudract number
2014-002950-38
Clinicaltrials.gov Identifier
P/059/2014, EMA Decision number of Paediatric Investigation Plan
Duration of Study in the UK
3 years, 11 months, 0 days
Research summary
Cancer is the most common fatal paediatric disease in the developed world. Solid tumours constitute approximately 60% of childhood cancers with lymphoma making up part of the remaining 40%. The incidence of paediatric melanoma (skin cancer) has increased over the last 30 years. While survival for childhood cancers has improved overall, the disease burden caused by certain poor prognosis paediatric tumours presents a significant unmet medical need and for these patients novel therapies are desperately needed.
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells PD1 becomes activated by programmed cell death ligand 1 (PDL1) and PDL2 which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug Pembrolizumab (MK-3475) has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
The purpose of the study is to establish the recommended paediatric dose of Pembrolizumab (MK-3475) for further safety, efficacy and tolerability evaluation. Children aged 6 months to less than 18 years of age with either; solid tumour expressing PDL1 on the surface of cancer cells, lymphoma or melanoma will be recruited.
The study will last approximately 2.5 years. Patients will receive Pembrolizumab (MK-3475) in 3 or 2 week dosing cycles for two years, and be monitored regularly for safety and clinical and/or radiographic evidence of disease progression.
Approximately 310 subjects will be enrolled in the study internationally and will take place at 1 UK hospital.
The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0121
Date of REC Opinion
8 Apr 2015
REC opinion
Further Information Favourable Opinion