A Study of Single Agent Pembrolizumab vs Single Agent Chemotherapy
Research type
Research Study
Full title
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician’s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) – (KEYNOTE-119)
IRAS ID
185316
Contact name
Nicholas Turner
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2015-001020-27
Duration of Study in the UK
2 years, 4 months, days
Research summary
Breast cancer is the most commonly diagnosed malignancy in women, accounting for 29% of all new cancers. Breast Cancer that does not have receptors (proteins that cells have) for oestrogen, progesterone and human epidermal growth factor (HER2) are known as triple-negative breast cancer (TNBC). TNBC represents 15-20% of all breast cancers and as it does not have the receptors mentioned above it is very difficult to treat. The majority of patients with metastatic TNBC have will have already received chemotherapy either before or after the surgery which removed the tumour but the cancer has worsened or come back.
The study medication in this study is pembrolizumab. Pembrolizumab is a type of immunotherapy and this type of treatment stimulates the body’s immune system to fight the cancer cells. [This differs from chemotherapy which acts directly to kill cancer cells]. Pembrolizumab targets and blocks a protein called PD-1 (programmed cell death 1) on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the immune system (T-cells) to find and kill cancer cells.
In earlier studies, Pembrolizumab has been shown to work in some other types of cancer and has been approved for the treatment of melanoma. However, it has not been approved for metastatic (the cancer has spread from the part of the body where it started to other parts of the body) Triple-Negative Breast Cancer.
Approximately 600 male and female subjects over the age of 18 with metastatic TNBC will be enrolled into this Phase III study which will last approximately 28 months and take place in 3 sites in the UK. The purpose of this study is to compare pembrolizumab with medications that area already used to treat metastatic triple-negative breast cancer.
Subjects will be split into 1 of 2 treatment groups depending on if their tumour has PD-L1 and on previous cancer medication. They will receive either pembrolizumab every 3 weeks or standard treatment which can be either capecitabine, eribulin, gemcitabine, or vinorelbine. The selection of the standard treatment will be made by the study doctors and the dosing for the standard treatment is as per routine practice at the hospital.
The study is funded by Merck Sharp & Dohme Limited
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1990
Date of REC Opinion
29 Feb 2016
REC opinion
Further Information Favourable Opinion