A Phase II Study of Pembrolizumab in Subjects with Triple-Negative Breast Cancer
Research type
Research Study
Full title
A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) – (KEYNOTE-086)
IRAS ID
181565
Contact name
Peter Schmid
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-000294-13
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Breast cancer is the most commonly diagnosed malignancy in women, accounting for 29% of all new cancers. Breast Cancer that tests negative for estrogen receptors (ER), progesterone receptors (PR) & human epidermal growth factor receptor-2 (HER2) are known as Triple-negative breast cancer (TNBC). TNBC represents 15-20% of all breast cancers and is challenging as these tumours lack a biological targets, such as ER The majority of patients with metastatic TNBC (mTNBC) have experienced relapse after chemotherapy before or after surgery to remove a tumour for early or locally advanced disease.
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.
Approximately 245 male and female subjects over the age of 18 with mTNBC will be enrolled into this Phase II study which will last approximately 3 years and 2 months and take place in 2 sites in the UK. The purpose of this study is to examine the proportion of patients with a reduction in their tumour burden following pembrolizumab monotherapy for the treatment of mTNBC.
Subjects will be entered into 1 of 3 different groups depending on the stage of the study, whether they have received previous treatment and whether they are PD-L1 positive. They will receive Pembrolizumab in 3 week dosing cycles for up to two years and upto 12 months in the second course phase.The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1132
Date of REC Opinion
20 Aug 2015
REC opinion
Further Information Favourable Opinion