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atezolizumab plus SoC (n=360) vs. placebo plus SoC (n=189)
randomized controlled trial
atezolizumab
paclitaxel 175 mg/m2 carboplatin every 21 days for 6-8 cycles or PD. Atezolizumab IV1200 mg, every 21 days progression
placebo
paclitaxel 175 mg/m2 carboplatin every 21 days for 6-8 cycles or PD placebo IV every 21 days
Paclitaxel and Carboplatin
endometrial cancer
double-blind
89 sites across 10 countries
result from esmo congress 2023. no protocol available, no information about multiplicity control strategy and interim analysis management
avelumab plus SoC (n=63) vs. Standard of Care (SoC) (n=62)
randomized controlled trial
avelumab SoC
avelumab 10 mg/kg intravenously) added to carboplatin and paclitaxel (experimental group) every 3 weeks and then every 2 weeks as a single maintenance treatment after the end of chemotherapy
Standard of care
carboplatin AUC 5 and paclitaxel 175 mg/m² every 3 weeks for six to eight cycles
endometrial cancer
open label
31 centers, 1 country ( Italy)
dostarlimab plus soC (n=245) vs. placebo plus SoC (n=249)
randomized controlled trial
dostarlimab (500 mg)
dostalimab 500 mg plus carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area), every 3 weeks (six cycles), followed by dostarlimab (1000 mg) every 6 weeks for up to 3 years
placebo
placebo plus carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area), every 3 weeks (six cycles), followed by placebo every 6 weeks for up to 3 years
endometrial cancer
double-blind
113 sites in 19 countries
PFS dMMR 1 IA and 1 FA; PFS overall population 1FA; OS overall population 3IA and 1 FA
second IA (Powell et al.) from press realease 03/2024
dostarlimab plus soC (n=-9) vs. placebo plus SoC (n=249)
randomized controlled trial
dostarlimab (500 mg) followed by dostarlimab plus niraparib
dostalimab 500 mg plus carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area), every 3 weeks (six cycles), followed by dostarlimab (1000 mg) every 6 weeks for up to 3 years and niraparib 200 or 300 mg
placebo
placebo plus carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area), every 3 weeks (six cycles), followed by placebo every 6 weeks for up to 3 years and placebo
endometrial cancer
double-blind
113 sites in 19 countries
PFS dMMR 1 IA and 1 FA; PFS overall population 1FA; OS overall population 3IA and 1 FA
from press realease 03/2024 https://www.gsk.com/media/11029/sgo-ruby-data-press-release-final.pdf
durvalumab plus olaparib plus SoC (n=241) vs. placebo plus SoC (n=239)
randomized controlled trial
durvalumab
carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib
placebo
carboplatin/paclitaxel plus placebo followed by placebo maintenance (control arm)
platinum-based chemotherapy (paclitaxel carboplatin)
endometrial cancer
3 arms only two selected here
double-blind
22 countries
three treatment arms stratified by MMR status (proficient v deficient), disease status (newly diagnosed v recurrent), and geographic region (Asia v non-Asia)
may 2023 press release : PUBLISHED26 May 2023DUO-E is the first global Phase III trial of immunotherapy plus PARP inhibition to demonstrate clinical benefit in this settingPositive high-level results from the DUO-E Phase III trial showed IMFINZI® (durvalumab) in combination with platinum-based chemotherapy followed by either IMFINZI plus LYNPARZA® (olaparib) or IMFINZI alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in patients with newly diagnosed advanced or recurrent endometrial cancer. There was a greater clinical benefit observed with the combination of IMFINZI and LYNPARZA as maintenance treatment.
durvalumab plus SoC (n=238) vs. placebo plus SoC (n=239)
randomized controlled trial
durvalumab
carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus placebo
placebo
carboplatin/paclitaxel plus placebo followed by placebo maintenance (control arm)
platinum-based chemotherapy (paclitaxel carboplatin)
endometrial cancer
3 arms only two selected here
double-blind
22 countries
three treatment arms stratified by MMR status (proficient v deficient), disease status (newly diagnosed v recurrent), and geographic region (Asia v non-Asia)
may 2023 press release : PUBLISHED26 May 2023DUO-E is the first global Phase III trial of immunotherapy plus PARP inhibition to demonstrate clinical benefit in this settingPositive high-level results from the DUO-E Phase III trial showed IMFINZI® (durvalumab) in combination with platinum-based chemotherapy followed by either IMFINZI plus LYNPARZA® (olaparib) or IMFINZI alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in patients with newly diagnosed advanced or recurrent endometrial cancer. There was a greater clinical benefit observed with the combination of IMFINZI and LYNPARZA as maintenance treatment.
pembrolizumab plus lenvatinib (n=-9) vs. Standard of Care (SoC) (n=-9)
randomized controlled trial
pembrolizumab plus levitinib
lenvatinib 20 mg daily and pembrolizumab 200 mg once at the start of each 3-week treatment cycle.Pembrolizumab must be stopped after 35 cycles, butlenvatinib may continue after stopping pembrolizumab
carboplatine plus paclitaxel
paclitaxel 175mg/m² and carboplatin once at the start of each 3-week treatment cycle. . Patients couldhave received up to seven cycles of paclitaxel/carboplatin; however, chemotherapy treatment beyond seven cycles was permitted for patients who continued to derive clinical benefit
endometrial cancer
open design
190 community clinics and academic hospitals in 22 countries
press release from 2024 SGO annual muuting on women's cancer
pembrolizumab plus lenvatinib (n=411) vs. Standard of Care (SoC) (n=416)
randomized controlled trial
pembrolizumab plus lenvatinib
oral lenvatinib at 20 mg daily and pembrolizumab at 200 mg intravenously (IV) every 3 weeks
Paclitaxel or Doxorubicin
doxorubicin at 60 mg/m2 IV every 3 weeks or paclitaxel at 80 mg/m2 IV weekly on a 3-weeks-on/1-week-off schedule
endometrial cancer
Randomization to treatment group was initially stratified according to MMR status (deficient [dMMR] or proficient [pMMR]). Furthermore, within the pMMR population, patients were stratified according to ECOG performance-status score (0 or 1), geographic region (region 1 [Australia, Canada, Europe, Israel, New Zealand, and the United States] or region 2 [rest of the world]), and history of pelvic irradiation (yes or no)
open design
167 sites in 21 countries
P3 / 1-sided at 0.025 / PFS at 0.0005 and OS at 0.0245
Lenvatinib plus pembrolizumab showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival [PFS], and objective response rate [ORR] versus treatment of physician’s choice, regardless of MMR status in endometrial cancer following prior platinum-based chemotherapy,
pembrolizumab plus SoC (n=112) vs. placebo plus SoC (n=113)
randomized controlled trial
pembrolizumab
pembrolizumab along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks.
placebo
placebo along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks.
in Addition to Paclitaxel and Carboplatin
endometrial cancer
double-blind
395 sites in four countries (the United States, Canada, Japan, and South Korea
Interim analyses were scheduled to be triggered after the occurrence of at least 84 events of death or progression in the dMMR cohort and at least 196 events in the pMMR cohort.. The trial was temporarily paused to enrollment from April 2020 to November 2020 because of the coronavirus disease 2019
results from interim analysis
pembrolizumab plus SoC (n=295) vs. placebo plus SoC (n=296)
randomized controlled trial
pembrolizumab
pembrolizumab along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks.
placebo
placebo along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks.
in Addition to Paclitaxel and Carboplatin
endometrial cancer
Patients will be randomized in a 1:1 fashion to treatment arms 1 and 2 after prospectively stratifying them by mismatch repair deficiency(yes versus no), performance status (0 or 1 versus 2), and prior chemotherapy (yes versus no)
double-blind
395 sites in four countries (the United States, Canada, Japan, and South Korea
Interim analyses were scheduled to be triggered after the occurrence of at least 196 events in the pMMR cohort.. The trial was temporarily paused to enrollment from April 2020 to November 2020 because of the coronavirus disease 2019
results from interim analysis
pembrolizumab plus SoC (n=-9) vs. placebo plus SoC (n=-9)
randomized controlled trial
pembrolizumab
pembrolizumab: 200mg Q3W for 6 cycles and chemotherapy: (carboplatin area under the curve [AUC] 5 or 6 paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 paclitaxel 60 mg/m2 QW) in stage 1 / pembrolizumab: 400mg Q6W for 6 cycles in stage 2
placebo
placebo and chemotherapy: (carboplatin area under the curve [AUC] 5 or 6 paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 paclitaxel 60 mg/m2 QW) in stage 1 / placebo in stage 2
Adjuvant Chemotherapy With or Without Radiotherapy
endometrial cancer - (neo)adjuvant (NA)
double blind
result from press release (05/2024)
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