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| Diagnosis | Melanoma, Lymphoma, Solid Tumor, Hodgkin Lymphoma, Microsatellite-instability-high Solid Tumor, Non-Hodgkin Lymphoma, Other solid tumours | Study Status | Closed to enrollment |
| Phase | I/II |
| Age | Child - (6 Months to 17 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | intravenous |
| Last Posted Update | 2023-01-05 |
| ClinicalTrials.gov # | NCT02332668 |
International Sponsor
Merck Sharp & Dohme Corp.Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Vijay RamaswamyCentres
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Study Description
This is a study of pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:
- advanced melanoma (now only open for patients age 12-18)
- advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed)
- relapsed or refractory classical Hodgkin lymphoma
- advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
- advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"
Pembrolizumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells. The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, pembrolizumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.
This study has two parts. Part 1 will find the recommended dose for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy of pembrolizumab therapy.
Inclusion Criteria
- Age between 6 months and <18 years (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma)
- Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications
Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.
