click on circles to display study description...
avelumab alone (n=188) vs. pegylated liposomal doxorubicin (n=190)
randomized controlled trial
avelumab
avelumab 10 mg/kg monotherapy as a 1-h iv. infusion once every 2 weeks
Pegylated liposomal doxorubicin
PLD alone as a 1-h iv. infusion every 4 weeks.
3 arm : avelumab mono or in combination with PLD vs PLD, Antihistamine and acetaminophen premedication was mandatory 30–60 min before avelumab infusions, but was optional before PLD infusions. Crossover between study groups was not permitted.
metastatic/advanced OC (mOC) - 2nd line (L2)
open design
149 hospitals and cancer treatment centres in 24 countries.
P3/one sided and on interim analysis. Use of atypical repeated IC!! The overall type Ierror rate was maintained at or below a one-sided significance level of 0∙025 by allocating an α level of 0∙0115 to each overall survival comparison and 0∙001 to each progression-free survival comparison.Because three of four primary endpointcomparisons had crossed the futility boundary, the final analysis of these three endpoints was rendered exploratory.
Neither avelumab plus PLD nor avelumab alone significantly improved progression-free survival oroverall survival versus PLD
avelumab plus pegylated liposomal doxorubicin (n=188) vs. pegylated liposomal doxorubicin (n=190)
randomized controlled trial
avelumab plus PLD
avelumab 10 mg/kg monotherapy as a 1-h iv. infusion once every 2 weeks and PLD alone as a 1-h iv. infusion every 4 weeks (before avalumab infusion).
Pegylated liposomal doxorubicin
PLD alone as a 1-h iv. infusion every 4 weeks.
3 arm : avelumab mono or in combination with PLD vs PLD, Antihistamine and acetaminophen premedication was mandatory 30–60 min before avelumab infusions, but was optional before PLD infusions. Crossover between study groups was not permitted.
metastatic/advanced OC (mOC) - 2nd line (L2)
open design
149 hospitals and cancer treatment centres in 24 countries.
The overall type Ierror rate was maintained at or below a one-sided significance level of 0∙025 by allocating an α level of 0∙0115 to each overall survival comparison and 0∙001 to each progression-free survival comparison.Because three of four primary endpoint comparisons had crossed the futility boundary, the final analysis of these three endpoints was rendered exploratory
Neither avelumab plus PLD nor avelumab alone significantly improved progression-free survival oroverall survival versus PLD
nivolumab plus ipilimumab (n=49) vs. nivolumab alone (n=51)
randomized controlled trial
nivolumab plus ipilimumab
fourintravenous infusions of nivolumab 3 mg/kg plus ipilimumab1 mg/kg every 3 weeks (nivolumab plus ipilimumab).
nivolumab
fourintravenous infusions of nivolumab 3 mg/kg every 2 weeks(nivolumab)
Eachinduction regimen was followed by a common maintenanceregimen: nivolumab 3 mg/kg every 2 weeks for a maximumof 42 doses.
metastatic/advanced OC (mOC) - 2nd line (L2)
open label
37 academic and community centers in the United States,
P2/ one sided (15%) and no interim analysis. An interim report will be given to the DMC once the first stage data is mature.
Compared with nivolumab alone, the combination of nivolumab and ipilimumab in EOC did not show superior in response rate, with toxicity of the combination regimen comparable toprior reports.
powered by vis.js Network