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atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (n=285) vs. bevacizumab plus carboplatin and paclitaxel (n=289)
randomized controlled trial
atezolizumab
atezolizumab plus bevacizumab and chemotherapy (weekly paclitaxel or pegylated liposomal doxorubicin)
Soc
bevacizumab at 10 mg/kg every 2 weeks and either weekly paclitaxel at 80 mg/m2 in a 28-day cycle or pegylated liposomal doxorubicin (PLD) at 40 mg/m2 on day 1 of a 28-day cycle.
metastatic/advanced OC (mOC) - 1st line (L1)
double-blind
from asco https://www.oncnursingnews.com/view/adding-atezolizumab-to-chemo-bevacizumab-may-not-be-beneficial-in-ovarian-cancer
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.
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.
nivolumab based treatment (n=-9) vs. rucaparib (n=-9)
randomized controlled trial
combination of rucaparib (Rubraca®) andnivolumab as maintenance treatment
rucaparib alone
metastatic/advanced OC (mOC) - maintenance (M)
double blind
24 countries
atezolizumab plus SoC (n=651) vs. placebo plus SoC (n=650)
randomized controlled trial
atezolizumab plus paclitaxel carboplatin and bevacizumalb
atezolizumab 1,200 mg on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
placeb plus paclitaxel carboplatin and bevacizumalb
placebo on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
neoadjuvant cohort,were randomly assigned before starting studytherapy to receive either atezolizumab 1,200 mg or placebo on day 1 of cycles 1-22, both combined with paclitaxel andcarboplatin during cycles 1-6 as above.
mOC - L1 - all population
double-blind
269 study location in North and South America, Europe, Asia, and Australia
P3/ two sided and one OS IA. PFS was tested in parallel in the PD-L1–positive and ITTpopulations (two-sided P 5 .002); OS was tested hierarchically(with the actual alpha spent dependent on the PFSresults) first in the PD-L1–positive population; if statisticalsignificance was reached, OS was tested further in the ITTpopulation.
Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosedOC. This trial fails to meet its primary endpoint
atezolizumab plus SoC (n=391) vs. placebo plus SoC (n=393)
randomized controlled trial
atezolizumab plus paclitaxel carboplatin and bevacizumalb
atezolizumab 1,200 mg on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
placeb plus paclitaxel carboplatin and bevacizumalb
placebo on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
neoadjuvant cohort,were randomly assigned before starting studytherapy to receive either atezolizumab 1,200 mg or placebo on day 1 of cycles 1-22, both combined with paclitaxel andcarboplatin during cycles 1-6 as above.
mOC - L1 - PDL1 positive
PDL1–positive (IC > 1%) populations.
double-blind
269 study location in North and South America, Europe, Asia, and Australia
P3/ two sided and one OS IA. PFS was tested in parallel in the PD-L1–positive and ITTpopulations (two-sided P 5 .002); OS was tested hierarchically(with the actual alpha spent dependent on the PFSresults) first in the PD-L1–positive population; if statisticalsignificance was reached, OS was tested further in the ITTpopulation.
Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. This trial fails to meet its primary endpoint
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