Participant flow

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer · Source last updated 2026-08-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Platinum-based chemotherapy (paclitaxel and carboplatin) every 3 weeks (Q3W) for a maximum of 6 cycles with durvalumab placebo (intravenous \[IV\]) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) every 4 weeks (Q4W) and olaparib placebo (tablets) twice daily (bd) orally as maintenance treatment until disease progression.

   id

   FG000

   title

   Standard of Care (SoC)

2. description

   Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

   id

   FG001

   title

   SoC + Durvalumab

3. description

   Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

   id

   FG002

   title

   SoC + Durvalumab + Olaparib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         54

      3. group Id

         FG002

         num Subjects

         49

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         25

      3. group Id

         FG002

         num Subjects

         18

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         241

      2. group Id

         FG001

         num Subjects

         238

      3. group Id

         FG002

         num Subjects

         239

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         147

      2. group Id

         FG001

         num Subjects

         159

      3. group Id

         FG002

         num Subjects

         170

      comment

      Patients ongoing study at time of primary PFS analysis DCO: 12 Apr 2023

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         79

      3. group Id

         FG002

         num Subjects

         69

      type

      NOT COMPLETED

   title

   Global Cohort

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         13

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         43

      3. group Id

         FG002

         num Subjects

         42

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         29

      3. group Id

         FG002

         num Subjects

         24

      comment

      Patients ongoing study at time of primary PFS analysis DCO: 08 Jul 2024

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         18

      type

      NOT COMPLETED

   title

   China Cohort

pre Assignment Details

It was planned that approximately 699 women from the Global cohort and 129 women from the China cohort, with newly diagnosed advanced or recurrent endometrial cancer, were to receive durvalumab/placebo in combination with platinum-based chemotherapy followed by maintenance durvalumab/placebo (same treatment as during chemotherapy phase) and olaparib/placebo in a 1:1:1 ratio.

recruitment Details

Global Cohort: 875 patients screened across 179 centres in 22 countries; 718 were randomised. Results were reported for analysis of progression-free survival (PFS) (data cut-off \[DCO\]: 12 Apr 2023). China Cohort: 172 patients screened across 25 sites; 129 were randomized. Results were reported for analysis of PFS (DCO: 08 Jul 2024). In total, 805 patients were randomised; 718 to the Global cohort, 129 to the China cohort, with 42 patients overlapping and belonging to both cohorts.

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Preserved source evidence · Not medical advice