A Phase II Study of BGBC008 in Combination with Pembrolizumab
Research type
Research Study
Full title
A Phase II Multi-Center Study of BGB324 in Combination with Pembrolizumab in Patients with Previously Treated Advanced Adenocarcinoma of the Lung.
IRAS ID
220385
Contact name
James Spicer
Contact email
Sponsor organisation
BerGenBio AS
Eudract number
2016-003609-32
Duration of Study in the UK
4 years, 4 months, 31 days
Research summary
This is a Phase II research study of an experimental drug referred to as BGB324 in combination with Pembrolizumab, also known as KEYTRUDA.
BGB324 is a medicine which inhibits (blocks) the action of a protein called Axl kinase which is important in regulating the growth and survival of tumour cells. Axl belongs to a special family of proteins called receptor tyrosine kinases. Several well-known antitumour medicines block other receptor tyrosine kinases but BGB324 is one of a new class of medicines which targets Axl alone. In experimental models of tumour BGB324 has been shown to slow or in some situations completely stop tumour growth. In similar models the anti-tumour effects of BGB324 combined with the licensed medicine pembrolizumab were improved compared to the effect of either medicine alone.
Pembrolizumab is an immune checkpoint inhibitor which is a type of tumour treatment called an immunotherapy. It is designed to boost the body's natural defenses (the immune system) to fight the tumours. Tumour cells are able to hide from the immune system by using a protein called PD-L1. Pembrolizumab stops the tumour from evading (hiding from) the immune system by enabling the T-cell to detect the tumour cell and this enables the participants immune system to fight their tumour naturally.
The study is intended to know the effects (good or bad) that this combination of two medications has on the type of lung tumour that the participants have.This study will be done at hospitals in Norway, UK, Spain and the US and will involve up to 48 patients. The participant’s treatment in the study will continue for as long as they receive benefit from the treatment, with a maximum of 24 months. The study is likely to last for over 3 years.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0418
Date of REC Opinion
9 Jun 2017
REC opinion
Further Information Favourable Opinion