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Active, not recruitingNCT04269200DUO-EUpdated Aug 7, 2026Results posted

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

A Phase 3 interventional study of olaparib and durvalumab in Endometrial Neoplasms, sponsored by AstraZeneca. Active, not recruiting at 201 sites in 22 countries. Open to female participants aged 18 Years to 150 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
805
Allocation
Randomized
Ages
18 Years to 150 Years
Sex
Female
01

Study summary

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Read the detailed description

This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer

02

Conditions studied

  • Endometrial Neoplasms

Keywords

  • Cancer of Endometrium
  • Cancer of the Endometrium
  • Carcinoma of Endometrium
  • Endometrial Cancer
  • Endometrial Carcinoma
  • Endometrium Cancer
  • Neoplasms, Endometrial
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 805 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 150 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18 years at the time of screening and female.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.

  • Patient must have endometrial cancer in one of the following categories:

    1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
    2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
    3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
  • Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse
  • FPPE tumor sample must be available for MMR evaluation.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

Exclusion criteria

Exclusion Criteria:

  • History of leptomeningeal carcinomatosis.
  • Brain metastases or spinal cord compression.
  • Prior treatment with PARP inhibitors.
  • Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
805 participants (actual)

Study arms

  • Active comparator
    Arm A (control)

    Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).

    Drug: durvalumab placebo · Drug: olaparib placebo · Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Arm B (durvalumab+placebo)

    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo

    Biological: durvalumab · Drug: olaparib placebo · Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Arm C (durvalumab+olaparib)

    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

    Drug: olaparib · Biological: durvalumab · Drug: Carboplatin · Drug: Paclitaxel

Interventions

  • Drugolaparib

    Olaparib tablets

  • Biologicaldurvalumab

    Durvalumab by intravenous infusion

  • Drugdurvalumab placebo

    Matching placebo for intravenous infusion

  • Drugolaparib placebo

    Placebo tablets to match olaparib

  • DrugCarboplatin

    Standard of care chemotherapy

  • DrugPaclitaxel

    Standard of care chemotherapy

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

    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 frame: 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

Secondary outcomes

  1. Overall Survival (OS) Analysis

    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 frame: Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months

  2. Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice

    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 frame: 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

  3. Objective Response Rate (ORR) Based on Investigator Assessment

    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 frame: 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

  4. Duration of Response (DoR) Based on Investigator Assessment

    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 frame: 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

  5. Time From Randomisation to First Subsequent Therapy or Death (TFST)

    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 frame: Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

  6. Time From Randomisation to Second Subsequent Therapy or Death (TSST)

    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 TSST

    Time frame: Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

  7. Time From Randomisation to Discontinuation of Treatment or Death (TDT)

    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 TDT

    Time frame: Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months

  8. Serum Concentration of Durvalumab

    To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib

    Time frame: PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)

  9. Anti-drug Antibodies (ADA) to Durvalumab

    To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib

    Time frame: Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)

  10. 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)

    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.

  11. Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

    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.

07

Results

Posted Dec 23, 2025

Participant flow

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.

Global Cohort
Participant flow — Global Cohort
MilestoneStandard of Care (SoC)SoC + DurvalumabSoC + Durvalumab + Olaparib
Started241238239
Completed147159170
Not completed947969
Withdrew: Death725449
Withdrew: Lost to follow-up002
Withdrew: Withdrawal by subject222518
China Cohort
Participant flow — China Cohort
MilestoneStandard of Care (SoC)SoC + DurvalumabSoC + Durvalumab + Olaparib
Started444342
Completed302924
Not completed141418
Withdrew: Death121113
Withdrew: Lost to follow-up011
Withdrew: Withdrawal by subject224

Outcome measures

PrimaryProgression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

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 frame:
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
Reported as:
Median · Months
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
MonthsGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoCChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments9.6 (9.0 to 9.9)10.2 (9.7 to 14.7)15.1 (12.6 to 20.7)9.7 (7.6 to 12.3)9.9 (8.2 to 20.6)9.9 (7.1 to 12.6)
Statistical analysis
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab · Regression, Cox · p = 0.003 (Determined using a log-rank test stratified by mismatch repair (MMR) status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).) · Hazard ratio (hr): 0.71 · 95% CI 0.57 to 0.89A hazard ratio less than 1 favours SoC + Durvalumab.
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).) · Hazard ratio (hr): 0.55 · 95% CI 0.43 to 0.69A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
  • China Cohort - SoC vs China Cohort - SoC + Durvalumab · Regression, Cox · Hazard ratio (hr): 0.73 · 95% CI 0.42 to 1.25A hazard ratio less than 1 favours SoC + Durvalumab.
  • China Cohort - SoC vs China Cohort - SoC + Durvalumab + Olaparib · Regression, Cox · Hazard ratio (hr): 0.96 · 95% CI 0.57 to 1.61A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
SecondaryOverall Survival (OS) Analysis

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 frame:
Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months

Results for this outcome have not been posted.

SecondaryTime From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice

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 frame:
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
Reported as:
Median · Months
Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice
MonthsGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoCChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice19.1 (16.4 to 22.9)22.2 (18.7 to NA)NA (NA to NA)24.2 (15.5 to NA)19.7 (15.3 to NA)15.3 (12.7 to NA)
Statistical analysis
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab · Regression, Cox · Hazard ratio (hr): 0.80 · 95% CI 0.59 to 1.07A hazard ratio less than 1 favours SoC + Durvalumab.
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib · Regression, Cox · Hazard ratio (hr): 0.55 · 95% CI 0.40 to 0.76A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.
  • China Cohort - SoC vs China Cohort - SoC + Durvalumab · Regression, Cox · Hazard ratio (hr): 1.03 · 95% CI 0.48 to 2.21A hazard ratio less than 1 favours SoC + Durvalumab.
  • China Cohort - SoC vs China Cohort - SoC + Durvalumab + Olaparib · Regression, Cox · Hazard ratio (hr): 1.38 · 95% CI 0.68 to 2.90A hazard ratio less than 1 favours SoC + Durvalumab.
SecondaryObjective Response Rate (ORR) Based on Investigator Assessment

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 frame:
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
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR) Based on Investigator Assessment
Percentage of participantsGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoCChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
Objective Response Rate (ORR) Based on Investigator Assessment55.161.963.659.559.445.5
Statistical analysis
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab · Regression, Logistic · Odds ratio (or): 1.32 · 95% CI 0.89 to 1.98An odds ratio greater than 1 favours SoC + durvalumab.
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib · Regression, Logistic · Odds ratio (or): 1.44 · 95% CI 0.95 to 2.18An odds ratio greater than 1 favours SoC + durvalumab + Olaparib.
SecondaryDuration of Response (DoR) Based on Investigator Assessment

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 frame:
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
Reported as:
Median · Months
Duration of Response (DoR) Based on Investigator Assessment
MonthsGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + Olaparib
Duration of Response (DoR) Based on Investigator Assessment7.7 (5.1 to 13.5)13.1 (6.0 to NA)21.3 (8.1 to 29.9)
SecondaryTime From Randomisation to First Subsequent Therapy or Death (TFST)

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 frame:
Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

Results for this outcome have not been posted.

SecondaryTime From Randomisation to Second Subsequent Therapy or Death (TSST)

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 TSST

Time frame:
Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

Results for this outcome have not been posted.

SecondaryTime From Randomisation to Discontinuation of Treatment or Death (TDT)

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 TDT

Time frame:
Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months

Results for this outcome have not been posted.

SecondarySerum Concentration of Durvalumab

To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib

Time frame:
PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)
Reported as:
Geometric mean · μg/mL
Serum Concentration of Durvalumab
μg/mLGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
Day 85, pre-dose (Trough concentration)203.133538 ± 32.6196.218276 ± 31.7183.414442 ± 32.7NA ± NA
Day 183, pre-dose (Trough concentration)265.575840 ± 39.6236.315365 ± 38.0—NA ± NA
Follow-up 3-months (Last valid dose + 3 months)27.977227 ± 104.414.031316 ± 206.833.310921 ± 43.011.252155 ± 1429.7
SecondaryAnti-drug Antibodies (ADA) to Durvalumab

To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib

Time frame:
Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)
Reported as:
Number · Number of participants
Anti-drug Antibodies (ADA) to Durvalumab
Number of participantsGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
ADA-positive at any visit (ADA prevalence)8901
Treatment-emergent ADA-positive (ADA incidence)2000
Treatment-boosted ADA0000
Treatment-induced ADA (positive post-baseline only)2000
ADA positive at baseline only6901
ADA positive post-baseline and positive at baseline0000
Persistently positive2000
Transiently positive0000
Neutralising antibody positive at any visit1000
SecondaryChange 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)

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.
Reported as:
Least squares mean · Score on a scale
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 on a scaleGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + Olaparib
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)-5.3 ± 1.03-3.6 ± 1.02-5.9 ± 0.98
Statistical analysis
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab · Mixed model for repeated measures · Least-squares mean difference: 1.7 · 95% CI -1.2 to 4.5Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib · Mixed model for repeated measures · Least-squares mean difference: -0.6 · 95% CI -3.4 to 2.2Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
SecondaryChange From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

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.
Reported as:
Least squares mean · Score on a scale
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
Score on a scaleGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + Olaparib
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30-2.8 ± 0.93-2.7 ± 0.92-3.6 ± 0.88
Statistical analysis
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab · Mixed model for repeated measures · Least-squares mean difference: 0.0 · 95% CI -2.5 to 2.6Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
  • Global Cohort - SoC vs Global Cohort - SoC + Durvalumab + Olaparib · Mixed model for repeated measures · Least-squares mean difference: -0.9 · 95% CI -3.4 to 1.6Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.

Adverse events

Collected over 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. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Global Cohort - SoC82/241 (34%)73/236 (30.9%)233/236 (98.7%)
Global Cohort - SoC + Durvalumab65/238 (27.3%)73/235 (31.1%)228/235 (97%)
Global Cohort - SoC + Durvalumab + Olaparib52/239 (21.8%)85/238 (35.7%)236/238 (99.2%)
China Cohort - SoC12/44 (27.3%)14/44 (31.8%)44/44 (100%)
China Cohort - SoC + Durvalumab11/43 (25.6%)8/41 (19.5%)41/41 (100%)
China Cohort - SoC + Durvalumab + Olaparib14/42 (33.3%)19/41 (46.3%)39/41 (95.1%)
Most frequent serious events
Showing 10 of 208
Most frequent serious events
EventGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoCChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
AnaemiaBlood and lymphatic system disorders10/2361/23516/2381/441/414/41
Alanine aminotransferase increasedInvestigations0/2360/2350/2381/442/410/41
Aspartate aminotransferase increasedInvestigations0/2360/2350/2381/440/412/41
PyrexiaGeneral disorders1/2361/2353/2380/441/412/41
Platelet count decreasedInvestigations0/2361/2351/2382/440/410/41
DizzinessNervous system disorders1/2361/2350/2382/441/410/41
Febrile neutropeniaBlood and lymphatic system disorders8/2364/2357/2382/440/410/41
Urinary tract infectionInfections and infestations5/2362/2356/2380/440/410/41
MyelosuppressionBlood and lymphatic system disorders1/2360/2352/2381/440/411/41
SepsisInfections and infestations3/2362/2354/2380/441/410/41
Most frequent other events
Showing 10 of 99
Most frequent other events
EventGlobal Cohort - SoCGlobal Cohort - SoC + DurvalumabGlobal Cohort - SoC + Durvalumab + OlaparibChina Cohort - SoCChina Cohort - SoC + DurvalumabChina Cohort - SoC + Durvalumab + Olaparib
AnaemiaBlood and lymphatic system disorders121/236111/235141/23836/4428/4134/41
White blood cell count decreasedInvestigations40/23629/23538/23832/4430/4131/41
Neutrophil count decreasedInvestigations60/23643/23550/23830/4430/4129/41
AlopeciaSkin and subcutaneous tissue disorders118/236118/235121/23829/4420/4126/41
NauseaGastrointestinal disorders105/23695/235129/23818/4411/4118/41
Platelet count decreasedInvestigations37/23636/23539/23821/4413/4115/41
HypoaesthesiaNervous system disorders12/2369/23515/23816/447/4118/41
VomitingGastrointestinal disorders42/23646/23561/23811/4411/4118/41
FatigueGeneral disorders87/23682/23593/2384/442/416/41
Alanine aminotransferase increasedInvestigations18/23630/23530/23817/4416/4111/41

Baseline characteristics

Global cohort: 241 SoC, 238 SoC + Durvalumab, 239 SoC + Durvalumab + Olaparib China cohort: 44 SoC, 43 SoC + Durvalumab, 42 SoC + Durvalumab + Olaparib There were 42 patients included in both Global and China cohorts (15 SOC, 14 SoC + Durvalumab, 13 SoC + Durvalumab + Olaparib).

Age, Continuous
Age, Continuous(Years)SoC (Global Cohort & China Cohort)SoC + Durvalumab (Global Cohort & China Cohort)SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)Total
Global cohort62.1 ± 10.3663.3 ± 9.8262.4 ± 9.9062.6 ± 10.03
China cohort58.3 ± 8.7357.6 ± 10.5759.3 ± 8.4158.4 ± 9.24
Age, Customized
Age, Customized(Participants)SoC (Global Cohort & China Cohort)SoC + Durvalumab (Global Cohort & China Cohort)SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)Total
Global cohort — <65 years124122135381
Global cohort — >=65 years117116104337
China cohort — <65 years35303095
China cohort — >=65 years9131234
Sex/Gender, Customized
Sex/Gender, Customized(Participants)SoC (Global Cohort & China Cohort)SoC + Durvalumab (Global Cohort & China Cohort)SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)Total
Global cohort — Female241238239718
China cohort — Female444342129
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SoC (Global Cohort & China Cohort)SoC + Durvalumab (Global Cohort & China Cohort)SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)Total
Global cohort — Hispanic or Latino20283280
Global cohort — Not Hispanic or Latino218208206632
Global cohort — Unknown or Not Reported3216
China cohort — Hispanic or Latino0000
China cohort — Not Hispanic or Latino444342129
China cohort — Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SoC (Global Cohort & China Cohort)SoC + Durvalumab (Global Cohort & China Cohort)SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)Total
Global cohort — White143136133412
Global cohort — Asian737270215
Global cohort — Black or African American10111435
Global cohort — Other1081230
Global cohort — American Indian or Alaska Native06612
Global cohort — Native Hawaiian or Other Pacific Islander2013
Global cohort — Not reported35311
China cohort — White0000
China cohort — Asian444342129
China cohort — Black or African American0000
China cohort — Other0000
China cohort — American Indian or Alaska Native0000
China cohort — Native Hawaiian or Other Pacific Islander0000
China cohort — Not reported0000
08

Study locations

201 sites
  • Research Site
    Tucson, Arizona 85719, United States
  • Research Site
    Concord, California 94520-2278, United States
  • Research Site
    La Jolla, California 92093, United States
  • Research Site
    San Francisco, California 94158, United States
  • Research Site
    Santa Barbara, California 93105, United States
  • Research Site
    Aurora, Colorado 80012, United States
  • Research Site
    Fort Lauderdale, Florida 33316, United States
  • Research Site
    Tampa, Florida 33612, United States
  • Research Site
    Savannah, Georgia 31404, United States
  • Research Site
    Honolulu, Hawaii 96826, United States
  • Research Site
    Arlington Heights, Illinois 60005, United States
  • Research Site
    Chicago, Illinois 60637, United States
  • Research Site
    Indianapolis, Indiana 46237, United States
  • Research Site
    Louisville, Kentucky 40207, United States
  • Research Site
    Baton Rouge, Louisiana 70817, United States
  • Research Site
    Boston, Massachusetts 02111, United States
  • Research Site
    Saint Paul, Minnesota 55125, United States
  • Research Site
    Jackson, Mississippi 39216, United States
  • Research Site
    Lebanon, New Hampshire 03756, United States
  • Research Site
    Camden, New Jersey 08103, United States
  • Research Site
    Paramus, New Jersey 07652, United States
  • Research Site
    New York, New York 10011, United States
  • Research Site
    New York, New York 10029, United States
  • Research Site
    Pinehurst, North Carolina 28374, United States
  • Research Site
    Cleveland, Ohio 44109, United States
  • Research Site
    Cleveland, Ohio 44124, United States
  • Research Site
    Dayton, Ohio 45459, United States
  • Research Site
    Oklahoma City, Oklahoma 73104, United States
  • Research Site
    Tulsa, Oklahoma 74134, United States
  • Research Site
    Eugene, Oregon 97401, United States
  • Research Site
    Tigard, Oregon 97223, United States
  • Research Site
    Pittsburgh, Pennsylvania 15224, United States
  • Research Site
    Providence, Rhode Island 02905, United States
  • Research Site
    Sioux Falls, South Dakota 57105, United States
  • Research Site
    Chattanooga, Tennessee 37403, United States
  • Research Site
    Germantown, Tennessee 38138, United States
  • Research Site
    Knoxville, Tennessee 37920, United States
  • Research Site
    Bedford, Texas 76022, United States
  • Research Site
    Dallas, Texas 75231, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    San Antonio, Texas 78240, United States
  • Research Site
    Sugar Land, Texas 77479, United States
  • Research Site
    Tyler, Texas 75702, United States
  • Research Site
    Webster, Texas 77598, United States
  • Research Site
    Fairfax, Virginia 22031, United States
  • Research Site
    Norfolk, Virginia 23502, United States
  • Research Site
    Seattle, Washington 98195, United States
  • Research Site
    Morgantown, West Virginia 26505, United States
  • Research Site
    Madison, Wisconsin 53792, United States
  • Research Site
    Milwaukee, Wisconsin 53226, United States
  • Research Site
    Clayton, 3168, Australia
  • Research Site
    Malvern, 3144, Australia
  • Research Site
    Melbourne, 3000, Australia
  • Research Site
    Nedlands, 6009, Australia
  • Research Site
    Sydney, NSW 2145, Australia
  • Research Site
    Bruges, 8000, Belgium
  • Research Site
    Brussels, 1200, Belgium
  • Research Site
    Charleroi, 6000, Belgium
  • Research Site
    Ghent, 9000, Belgium
  • Research Site
    Hasselt, 3500, Belgium
  • Research Site
    Kortrijk, 8500, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Libramont-Chevigny, 6800, Belgium
  • Research Site
    Liège, 4000, Belgium
  • Research Site
    Belo Horizonte, 30130-090, Brazil
  • Research Site
    Belo Horizonte, 30150-274, Brazil
  • Research Site
    Curitiba, 80520-174, Brazil
  • Research Site
    Passo Fundo, 99010-080, Brazil
  • Research Site
    Pelotas, 96020-080, Brazil
  • Research Site
    Porto Alegre, 90020-090, Brazil
  • Research Site
    Porto Alegre, 90035-003, Brazil
  • Research Site
    Porto Alegre, 90110-270, Brazil
  • Research Site
    Rio de Janeiro, 20231-050, Brazil
  • Research Site
    São José do Rio Preto, 15090-000, Brazil
  • Research Site
    São Paulo, 01246-000, Brazil
  • Research Site
    São Paulo, 01317-001, Brazil
  • Research Site
    Calgary, Alberta T2N 4N2, Canada
  • Research Site
    Toronto, Ontario M4N 3M5, Canada
  • Research Site
    Toronto, Ontario M5G 2M9, Canada
  • Research Site
    Montreal, Quebec H1T 2M4, Canada
  • Research Site
    Montreal, Quebec H2L 4M1, Canada
  • Research Site
    Montreal, Quebec H3A 1A1, Canada
  • Research Site
    Montreal, Quebec H3T 1E2, Canada
  • Research Site
    Beijing, 100034, China
  • Research Site
    Beijing, 100142, China
  • Research Site
    Changchun, 130012, China
  • Research Site
    Changchun, 130021, China
  • Research Site
    Changsha, 410003, China
  • Research Site
    Changsha, 410008, China
  • Research Site
    Chengdu, 610041, China
  • Research Site
    Chongqing, 400038, China
  • Research Site
    Chongqing, 408099, China
  • Research Site
    Dalian, 116001, China
  • Research Site
    Dalian, 116027, China
  • Research Site
    Guangdong, China
  • Research Site
    Guangzhou, 510060, China
  • Research Site
    Haikou, 570311, China
  • Research Site
    Harbin, 150081, China
  • Research Site
    Hefei, 230031, China
  • Research Site
    Nanning, 530021, China

Showing the first 100 of 201 sites across 22 countries.

09

References and documents

Publications

  • Westin SN, Moore K, Chon HS, Lee JY, Thomes Pepin J, Sundborg M, Shai A, de la Garza J, Nishio S, Gold MA, Wang K, McIntyre K, Tillmanns TD, Blank SV, Liu JH, McCollum M, Contreras Mejia F, Nishikawa T, Pennington K, Novak Z, De Melo AC, Sehouli J, Klasa-Mazurkiewicz D, Papadimitriou C, Gil-Martin M, Brasiuniene B, Donnelly C, Liu X, Nieuwenhuysen EV; DUO-E Investigators. Plain language summary of results from the DUO-E study: durvalumab given with or without olaparib in patients with advanced endometrial cancer. Future Oncol. 2026 Apr;22(9):1031-1046. doi: 10.1080/14796694.2026.2638677. Epub 2026 Apr 6. PubMed 41943281 ↗
  • Nishio S, Nishikawa T, Mori M, Kamiura S, Sumi T, Yunokawa M, Imai Y, Kondo E, Takehara K, Takano H, Kudaka W, Kado N, Yamagami W, Kato H, Nishino K, Usami T, Hamanishi J, Nii M, Takaya I, Okamoto A. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial. J Gynecol Oncol. 2025 Jul;36(4):e118. doi: 10.3802/jgo.2025.36.e118. PubMed 40590327 ↗
  • Bogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29. PubMed 38431043 ↗
  • Westin SN, Moore K, Chon HS, Lee JY, Thomes Pepin J, Sundborg M, Shai A, de la Garza J, Nishio S, Gold MA, Wang K, McIntyre K, Tillmanns TD, Blank SV, Liu JH, McCollum M, Contreras Mejia F, Nishikawa T, Pennington K, Novak Z, De Melo AC, Sehouli J, Klasa-Mazurkiewicz D, Papadimitriou C, Gil-Martin M, Brasiuniene B, Donnelly C, Del Rosario PM, Liu X, Van Nieuwenhuysen E; DUO-E Investigators. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. J Clin Oncol. 2024 Jan 20;42(3):283-299. doi: 10.1200/JCO.23.02132. Epub 2023 Oct 21. PubMed 37864337 ↗

Study documents

  • Study protocol · Jan 24, 2023
  • Statistical analysis plan · Nov 30, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04269200
Lead sponsor
AstraZeneca
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
May 5, 2020
Primary completion
Jul 8, 2024
Completion
Apr 1, 2027 (estimated)
Results posted
Dec 23, 2025
Last update
Aug 7, 2026

Study contacts

Shannon N. Westin, MD, MPH, FACOG
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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