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← KEYTRUDA QLEX: recurrent Endometrial Carcinoma

NCT04269200 · STUDY IN CONTEXT

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer

Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

→

secondary · NOT_POSTED

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS

Source null

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secondary · POSTED

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

→

secondary · POSTED

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of ORR

All participants with measurable disease at baseline were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong. Odds ratio only calculated for Global cohort (per statistical analysis plan \[SAP\]).

→

secondary · POSTED

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR

All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).

→

secondary · NOT_POSTED

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TFST

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT04269200
qol key
qol-0010
source section id
NCT04269200-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
measure definition
To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
time frame
At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores on the physical functioning score indicate better
population note
FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT04269200
qol key
qol-0011
source section id
NCT04269200-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
measure definition
To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.
time frame
At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores on the global health status/QoL indicate better
population note
FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT04269200
trial label
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
6
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    source section id
    NCT04269200-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
    endpoint definition
    To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
    time origin
    At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0001
    source section id
    NCT04269200-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) Analysis
    endpoint definition
    To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS
    time origin
    Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    source section id
    NCT04269200-om-0002
    source outcome index
    2
    endpoint
    Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice
    endpoint definition
    To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2
    time origin
    At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0003
    source section id
    NCT04269200-om-0003
    source outcome index
    3
    endpoint
    Objective Response Rate (ORR) Based on Investigator Assessment
    endpoint definition
    To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of ORR
    time origin
    At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants with measurable disease at baseline were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong. Odds ratio only calculated for Global cohort (per statistical analysis plan \[SAP\]).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0004
    source section id
    NCT04269200-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DoR) Based on Investigator Assessment
    endpoint definition
    To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR
    time origin
    At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0005
    source section id
    NCT04269200-om-0005
    source outcome index
    5
    endpoint
    Time From Randomisation to First Subsequent Therapy or Death (TFST)
    endpoint definition
    To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TFST
    time origin
    Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Global Cohort - SoC
    regimen
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    analyzed count
    241
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Global Cohort - SoC + Durvalumab
    regimen
    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.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Global Cohort - SoC + Durvalumab + Olaparib
    regimen
    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.
    analyzed count
    239
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG003
    arm label
    China Cohort - SoC
    regimen
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG004
    arm label
    China Cohort - SoC + Durvalumab
    regimen
    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.
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0000
    arm key
    OG005
    arm label
    China Cohort - SoC + Durvalumab + Olaparib
    regimen
    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.
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Global Cohort - SoC
    regimen
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    analyzed count
    241
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Global Cohort - SoC + Durvalumab
    regimen
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Global Cohort - SoC + Durvalumab + Olaparib
    regimen
    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.
    analyzed count
    239
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG003
    arm label
    China Cohort - SoC
    regimen
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG004
    arm label
    China Cohort - SoC + Durvalumab
    regimen
    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.
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    outcome key
    om-0002
    arm key
    OG005
    arm label
    China Cohort - SoC + Durvalumab + Olaparib
    regimen
    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.
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04269200-om-0002#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG000
    source section id
    NCT04269200-ae
    event group key
    EG000
    event group label
    Global Cohort - SoC
    serious affected
    73
    serious at risk
    236
    other affected
    233
    other at risk
    236
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG001
    source section id
    NCT04269200-ae
    event group key
    EG001
    event group label
    Global Cohort - SoC + Durvalumab
    serious affected
    73
    serious at risk
    235
    other affected
    228
    other at risk
    235
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG002
    source section id
    NCT04269200-ae
    event group key
    EG002
    event group label
    Global Cohort - SoC + Durvalumab + Olaparib
    serious affected
    85
    serious at risk
    238
    other affected
    236
    other at risk
    238
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG003
    source section id
    NCT04269200-ae
    event group key
    EG003
    event group label
    China Cohort - SoC
    serious affected
    14
    serious at risk
    44
    other affected
    44
    other at risk
    44
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG004
    source section id
    NCT04269200-ae
    event group key
    EG004
    event group label
    China Cohort - SoC + Durvalumab
    serious affected
    8
    serious at risk
    41
    other affected
    41
    other at risk
    41
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    harm key
    EG005
    source section id
    NCT04269200-ae
    event group key
    EG005
    event group label
    China Cohort - SoC + Durvalumab + Olaparib
    serious affected
    19
    serious at risk
    41
    other affected
    39
    other at risk
    41
    frequency threshold
    5
    collection period
    Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
    event definition
    Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    qol key
    qol-0010
    source section id
    NCT04269200-om-0010
    source outcome index
    10
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
    measure definition
    To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
    time frame
    At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores on the physical functioning score indicate better
    population note
    FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT04269200
    qol key
    qol-0011
    source section id
    NCT04269200-om-0011
    source outcome index
    11
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
    measure definition
    To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.
    time frame
    At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores on the global health status/QoL indicate better
    population note
    FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice