A Phase II Study of BGBC007 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, Locally Advanced and Unresectable or Metastatic Triple Negative Breast Cancer (TNBC) or Triple Negative Inflammatory Breast Cancer (TN-IBC).

• IRAS ID

  220218

• Contact name

  Anne Armstrong

• Contact email

  anne.armstrong@christie.nhs.uk

• Sponsor organisation

  BerGenBio AS

• Eudract number

  2016-003608-30

• Clinicaltrials.gov Identifier

  NCT03184558

• Duration of Study in the UK

  4 years, 8 months, 1 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 Axl) 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 breast tumour that the participants have.

  This study will be done at hospitals in Norway, UK, Spain and the US and will involve up to 56 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

  North West - Liverpool Central Research Ethics Committee

• REC reference

  17/NW/0036

• Date of REC Opinion

  4 Apr 2017

• REC opinion

  Further Information Favourable Opinion