Evaluation of Avelumab combined with Talazoparib in solid tumours
Research type
Research Study
Full title
A Phase 1b/2 Study to Evaluate Safety and Anti-tumour Activity of Avelumab in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Locally Advanced or Metastatic Solid Tumours.
IRAS ID
235395
Contact name
Marwa Ali
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2017-001509-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MSB0010718C, Investigational Product Name: Avelumab; MDV3800, BMN 673, Investigational Product Name: Talazoparib
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Cancer can advance by spreading 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. These have never been given together as a treatment for cancer, so this research study will also find the best dose of talazoparib to be given in combination with avelumab.
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 some cancer cells, where it protects those cells from being attacked by the immune system (part of the body that fights infection and 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.
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 that control cell behaviour). When PARP is turned off by talazoparib in cancer cells, DNA damage cannot be repaired and leads to the death of cancer cells. Talazoparib is an oral medication that will be taken once daily.
This research study will evaluate if the study drugs, avelumab and talazoparib will have greater effect on advanced cancers if given together than alone.
There are two parts to this study:
Phase 1b: different doses of talazoparib will be given to find best dose.
Phase 2: best dose of talazoparib will be given in combination with avelumab.Approximately 296 participants will participate in the study across 50 different research centres globally with 6-10 participants enrolled at each research site.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0416
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion