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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
avelumab plus SoC (n=-9) vs. Standard of Care (SoC) (n=-9)
randomized controlled trial
avelumab in maintenance plus carboplatin/paclitaxel
carboplatin/paclitaxel followed by observation
three-arm study : avelumab alone, avelumab in combination with carboplatin/paclitaxel and carboplatin/paclitaxel followed by observation in maintenance setting following frontline chemotherapy
metastatic/advanced OC (mOC) - maintenance (M)
open label
P3/ stopped
data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab* did not support the study’s initial hypothesis, and therefore the alliance made the decision to terminate the trial in alignment with the independent Data Monitoring Committee.
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