JAVELIN BRCA/ATM

• Research type

  Research Study

• Full title

  A phase 2 study to evaluate safety and anti-tumour activity of Avelumab in combination with Talazoparib in patients with BRCA or ATM mutant tumours

• IRAS ID

  246414

• Contact name

  Hendrik-Tobias Arkenau

• Contact email

  Tobias.Arkenau@hcahealthcare.co.uk

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2018-000345-39

• Clinicaltrials.gov Identifier

  NCT03565991

• Clinicaltrials.gov Identifier

  MSB0010718C, Investigational Product Name: Avelumab; MDV3800, BMN 673, Investigational Product Name: Talazoparib

• Duration of Study in the UK

  3 years, 9 months, 14 days

• Research summary

  Research Summary

  Cancer is the abnormal growth of cells which can spread into other parts of the body. The purpose of this research study is to learn the effects of the investigational drugs (a drug that is not approved for sale), avelumab and talazoparib as a combination in participants with locally advanced or metastatic BRCA or ATM mutant tumours.

  Avelumab is a monoclonal antibody, a type of protein that attaches to other proteins like PD-L1. PD-L1 is found on the surface of cancer cells, where it protects those cells from being attacked by the immune system (part of the body that fights infection/cancer). When avelumab attaches to PD-L1 it stops working and so allows the immune system to kill cancer cells. Avelumab is given into a vein in the arm over a 1-hour period of time.

  Avelumab is FDA approved to treat certain types of advanced cancer, but in this study, avelumab is an investigational drug because it is not approved for sale in this country for treatment of BRCA and ATM mutant tumours.

  Talazoparib is a drug that stops the activity of a protein called poly (adenosine diphosphate [ADP]-ribose) polymerase or PARP. PARP is involved in repairing damage to the DNA (set of instructions within cells controlling cell behaviour). When talazoparib turns off PARP in normal cells, other methods repair damage to DNA using intact BRCA1, 2 or ATM genes. However, in cancer cells these methods cannot be used when mutations in these genes are present. When PARP is turned off by talazoparib in cancer cells, DNA damage cannot be repaired and leads to death of cancer cells. Talazoparib is an oral medication taken once daily.

  Approximately 200 participants are expected to participate in the study across 60 different research centres globally with 3-10 participants enrolled at each research site.

  Lay summary of study results:
  Lay summary of study results are available at https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.pfizer.com%2F&data=05%7C01%7Cchelsea.rec%40hra.nhs.uk%7C45d961330ffa4f6e1b6e08dbc65d26d9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638321875602937465%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=cOHtX%2FM9ly68unlHvKLr4oNmKSm1nxGKkHiIOHFGsUk%3D&reserved=0

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/1805

• Date of REC Opinion

  17 Jan 2019

• REC opinion

  Further Information Favourable Opinion