A phase 2 trial of MK-3475 in participants with Hodgkin Lymphoma
Research type
Research Study
Full title
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667).
IRAS ID
275507
Contact name
Stephen Daw
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2017-001123-53
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 10 months, 29 days
Research summary
Hodgkin lymphoma (HL) is one of the most curable forms of childhood cancer, with an estimated 5 year survival rate exceeding 98%. However, the cure often comes with significant cost in the form of long term toxicity that can occur as a result of therapy.
Broadly the study hopes to examine the addition of a novel agent (pembrolizumab) that may help to reduce therapy and subsequent cumulative drug and radiation toxicity. This will be assessed by testing the safety and tolerability of pembrolizumab in combination with chemotherapy and how participants cancer responds. Long term survival will be monitored to study the longer lasting effects. Pembrolizumab is approved in the UK and USA among other countries in treating different cancers but is not approved to treat HL.
This study is an open-label uncontrolled trial of pembrolizumab that splits participants into low risk and high-risk groups. In the UK only the high-risk group will be investigated, as only the treatment for this group is in line with locally adopted practice. The treatment period will last for approximately 2 months to a year, follow up will then last at least 2 years. The total study duration should last approximately 6 years.
Participants will range in age from 3-25 years with newly diagnosed classical HL. After completing ABVD (low risk group) or OEPA (high risk group) induction chemotherapy, approximately 100 slow early responders (SERs) will be identified and treated with pembrolizumab in combination with AVD (low risk group) or COPDAC-28 (high risk group). Rapid early responders (RERs) in both groups will stop study treatment and will be treated with non-study consolidation chemotherapy.
440 participants are expected to participate worldwide with 11 expected in the UK. One hospital is expected to run the study in the UK. The study is funded by Merck Sharp & Dohme Limited.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0285
Date of REC Opinion
28 Apr 2020
REC opinion
Further Information Favourable Opinion