At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 566 enrolled
Drug / intervention
avelumab +1 morebiological
Likely dose
avelumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
In Brief
A Phase 3 clinical trial evaluating avelumab and PLD for Ovarian Cancer. Completed, enrolled 566 participants across 295 sites in 25 countries.
Detailed Summary
A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartDec 2015
Primary CompletionSep 2018
Study CompletionJul 2022
TodayJul 2026
First PostedOct 20, 2015
Enrollment StartDec 21, 2015
Primary CompletionSep 19, 2018
Study CompletionJul 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.7 years ago
Interventions
avelumabbiological
10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
PLDdrug
PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles