PAveMenT study
Research type
Research Study
Full title
PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple negative breast cancer
IRAS ID
245336
Contact name
Hanh Nguyen
Contact email
Sponsor organisation
The Royal Marsden Hospital NHS Foundation Trust
Eudract number
2018-004151-21
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.
We will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR)but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.
Palbociclib inhibits two proteins involved in cell growth called cyclin dependent kinase 4 and cyclin dependent kinase 6 (CDK4/6). Inhibiting CDK4/6 stops cells, such as cancer cells, from dividing and multiplying further. Its use is currently approved for the treatment of metastatic HR positive HER2 negative breast cancer, based on good results from large clinical trials.
Laboratory studies have shown that palbociclib might be also useful in some patients with triple negative breast cancer, an aggressive subtype of breast cancer that does not express the hormone receptors or HER2 receptor, but only if their cancer is positive for the androgen-receptor (AR).
Avelumab is an immunotherapy drug which does not itself destroy cancer cells, but tries to stimulate the body’s immune system to do this. Avelumab has been tested in a number of different types of tumours including breast cancer, but although approved for use in the USA, it is not currently an approved standard treatment in the UK. The combination of both drugs has never been tested in humans before.
It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/1962
Date of REC Opinion
6 Mar 2020
REC opinion
Further Information Favourable Opinion