A Phase Ib study of pembrolizumab plus chemotherapy in TNBC
Research type
Research Study
Full title
A Phase 1b Study to Evaluate safety and clinical activity of Pembrolizumab (MK-3475) in combination with Chemotherapy as Neoadjuvant Treatment for Triple Negative Breast Cancer (TNBC) - (KEYNOTE 173).
IRAS ID
190228
Contact name
Peter Schmid
Contact email
Sponsor organisation
Diamond BioPharm Limited
Eudract number
2015-002405-11
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Breast cancer is the most commonly diagnosed cancer and second leading cause of cancer death in women. Breast cancer that tests negative for estrogen receptors (ER), progesterone receptors (PR) & human epidermal growth factor receptor2 (HER2) is known as Triple negative breast cancer (TNBC). TNBC represents 15-20% of all breast cancers and is a challenging subgroup as these tumours lack biological targets, such as ER. Therefore the search for new treatments is crucial and arming the arming the immune system is one intriguing new approach.
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 is a potent & highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
The purpose of this study is to examine the safety, tolerability and clinical activity of pembrolizumab in combination with two chemotherapy regimens for the treatment of TNBC Approximately 60 female subjects over the age of 18 with TNBC will be enrolled into this Phase Ib study which will last approximately 42 weeks and take place in 3 sites in the UK..
Subjects will be randomly entered into 1 of 2 groups. Both groups will receive the study drug pembrolizumab but in combination with different chemotherapy regimens. They will receive study treatment for approximately 27 weeks (9 cycles).
The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/2034
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion