Study of Lenalidomide and Dexamethasone with or without Pembrolizumab
Research type
Research Study
Full title
A phase III study of Lenalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in newly diagnosed and treatment naïve Multiple Myeloma (KEYNOTE 185).
IRAS ID
192464
Contact name
Patricia Marinello
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-002901-12
Duration of Study in the UK
3 years, 3 months, 13 days
Research summary
Multiple Myeloma (MM) is a malignant plasma cell disorder characterized by end-organ damage, It is considered the second most common haematological malignancy and primarily affects elderly individuals.
Treatment depends on many factors, including eligibility for autologous stem cell transplant. Generally older patients have medical co-morbidities and poorer performance status and are less often eligible. Despite advances, nearly all MM patients relapse and have limited treatment options and poor prognosis
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 &2 (PDL1/2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. Several studies in hematologic malignancies have shown increased expression of PD -L1 in MM. PD-L1 is expressed on most MM plasma cells but not in normal plasma cells. The study drug Pembrolizumab (MK-3475) is a potent & highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Approximately 640 patients over the age of 18 with newly diagnosed and treatment-naïve MM and who are ineligible for auto-SCT will be enrolled into this Phase III study which will last approximately 41 months. The purpose of this study is to measure the progression free survival of patients treated with pembrolizumab in combination with chemotherapy as compared to those treated with chemotherapy only.
Subjects will be randomly entered into 1 of 2 groups to receive either pembrolizumab plus chemotherapy or chemotherapy only. Treatment will be administered every 3 weeks of repeated 28-day cycles for approximately 2 years.
The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0138
Date of REC Opinion
18 Mar 2016
REC opinion
Further Information Favourable Opinion