B9991030 - JAVELIN OVARIAN PARP 100
Research type
Research Study
Full title
A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP 100)
IRAS ID
247205
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2017-004456-30
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
126,174, IND Number
Duration of Study in the UK
4 years, 8 months, 0 days
Research summary
Summary of Research
The 5-year survival rate for women diagnosed with advanced ovarian cancer is less than 20% in the United Kingdom. Carboplatin in combination with paclitaxel is the current standard of care for epithelial ovarian cancer. Complete response is achieved in approximately 75% of patients, but the median progression-free survival (PFS) is approximately 18 months and most patients ultimately succumb to the disease.
Bevacizumab is approved in the EU to treat ovarian cancer. A significant number of patients receive bevacizumab in combination with induction chemotherapy followed by bevacizumab maintenance therapy.
Avelumab and talazoparib are new investigational drugs for the treatment of ovarian cancer. Avelumab is an antibody and is thought to work by helping the immune system fight cancer. Talazoparib is a drug that stops the repair of damage to the DNA within cancer cells, leading to the death of the cancer cells. The gene defects seen in ovarian cancer suggest these tumours may respond well to combination treatment with talazoparib and avelumab.
The purpose of this study is to determine whether using the study drug avelumab in combination with chemotherapy followed by study drugs avelumab plus talazoparib maintenance, is more effective in treating previously untreated ovarian cancer than chemotherapy plus bevacizumab followed by bevacizumab maintenance.
Participants will be randomly assigned to one of three treatment groups:
• Arm A - chemotherapy phase, carboplatin and paclitaxel + avelumab; maintenance phase, avelumab + talazoparib (40%)
• Arm B - chemotherapy phase, carboplatin and paclitaxel alone; maintenance phase, talazoparib alone (20%)
• Arm C - chemotherapy phase, carboplatin and paclitaxel + bevacizumab; maintenance phase, bevacizumab alone (40%)
Neither participants nor the study doctor can choose the study arm they will be in, but both will know which arm they are assigned to.There will be about 720 women from 25 countries taking part in this study.
Summary of Results
The summary of results are available at clinicaltrials.gov
REC name
HSC REC B
REC reference
18/NI/0204
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion