B9991010 Phase 3, avelumab for Untreated Epithelial Ovarian Cancer
Research type
Research Study
Full title
A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718C) in Combination with and/or Following Chemotherapy in Patients with Previously Untreated Epithelial Ovarian Cancer
IRAS ID
202233
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
Pfizer Ltd.
Eudract number
2015-003239-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 21 days
Research summary
Less than 40% of women diagnosed with ovarian cancer are cured. The current standard of care for ovarian cancer is carboplatin in combination with paclitaxel(Taxol). Complete response is achieved in approximately 75% of patients, but most patients ultimately succumb to the disease with median progression-free survival (PFS) of approximately 18 months.
The main purpose of this study is to see if adding the study drug, avelumab (MSB0010718C), to frontline chemotherapy (i.e. initial treatment for ovarian cancer patients), and adding avelumab maintenance treatment, is better (increase PFS) than chemotherapy alone, and observation alone for treating ovarian cancer. The chemotherapy drugs that will be used in this study are carboplatin and paclitaxel. The study drug is avelumab (MSB0010718C).
This study will focus on patients with previously untreated epithelial ovarian cancer, who are ≥18 years and meet the inclusion criteria.
This study consists of 2 phases, a chemotherapy phase and a maintenance phase.
In the chemotherapy phase, patients will receive carboplatin-paclitaxel alone (Arm A+B) or in combination with avelumab (Arm C). The Chemotherapy phase may last a maximum of 6 cycles (18 Weeks)and the maintenance phase is limited to 24 months with avelumab treatment or obesrvation only.Patients will be randomly assigned to a treatment arm by a computor system and treatment will be given by means of intravenous infusion (IV). Arms A+B in the Chemotherapy phase will be blinded to prevent, results being influenced unfairly. Arms A+B will be unblinded once the maintenance phase starts.
Patients would need to provide a archived tumour biospecimen, and need to provide a fresh tumour sample during the study.Randomisation groups:
Arm A: platinum-based chemotherapy alone followed by observation
Arm B: platinum-based chemotherapy alone followed by avelumab maintenance
Arm C: avelumab in combination with platinum-based chemotherapy followed by
avelumab maintenance.±950 women across 200 different research sites in 28 countries is expected to take part.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0142
Date of REC Opinion
29 Apr 2016
REC opinion
Favourable Opinion