MK-3475 (Pembrolizumab) in Subjects with Classical Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase II clinical trial of MK-3475 (pembrolizumab) in subjects with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
IRAS ID
180333
Contact name
Shelonitda Rose
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co Inc
Eudract number
2014-004482-24
Clinicaltrials.gov Identifier
118604, IND Number
Duration of Study in the UK
3 years, 0 months, 20 days
Research summary
Hodgkin lymphoma (HL) accounts for approximately 10 percent of all lymphomas and approximately 0.6 percent of all cancers diagnosed in the developed world annually. Although, HL is curable in 80% of patients diagnosed, new therapies are needed, especially for patients who present with advanced disease. For patients who experience relapse or progressive HL within 1 year after the standard care treatment, especially those who have received newer therapies such as brentuximab vedotin, the prognosis is exceedingly poor. They have a normal survival time of approximately 1.2 years, and the average progression free survival is less than 6 months. Patients who have progressed after treatment with brentuximab vedotin also have no currently available standard treatment and represent an urgent unmet medical need.
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 determine safety, tolerability, and effectiveness of pembrolizumab (MK-3475) in patients with relapsed and/ or refractory Hodgkin Lymphoma.
The study will last approximately 35 months. Patients will receive pembrolizumab (MK-3475) in 3 week dosing cycles for two years, and be monitored regularly for safety and clinical and/or radiographic evidence of disease progression.
Approximately 180 subjects will be enrolled in the study and will take place at 4 UK hospitals.
The study is funded by Merck Sharp & Dohme Limited.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0252
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion