Trial · NCT04269200
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
NCT04269200, Phase 3, Active not recruiting, AstraZeneca; results first posted 2025-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer. Trials, record NCT04269200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04269200
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
- NCT number
- NCT04269200
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 805 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Endometrial Neoplasms
- Interventions
- olaparib, durvalumab, durvalumab placebo, olaparib placebo, Carboplatin, Paclitaxel
- First posted
- 2020-02-13
- Last updated
- 2026-11-05
- Other registries' IDs
- eudract:2019-004112-60
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | 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 | 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 |
| Secondary | Overall Survival (OS) Analysis | Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months | 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 |
| Secondary | Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | 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 | 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 |
| Secondary | Objective Response Rate (ORR) Based on Investigator Assessment | 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 | 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 |
| Secondary | Duration of Response (DoR) Based on Investigator Assessment | 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 | 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 |
| Secondary | Time From Randomisation to First Subsequent Therapy or Death (TFST) | Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months) | 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 |
| Secondary | Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months) | 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 |
| Secondary | Time From Randomisation to Discontinuation of Treatment or Death (TDT) | Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months | 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 |
| Secondary | Serum Concentration of Durvalumab | PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months) | To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib |
| Secondary | Anti-drug Antibodies (ADA) to Durvalumab | 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) | To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | 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 | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Analysis | Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months | |||
| SECONDARY | Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | 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 | 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. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Based on Investigator Assessment | 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 | 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 \[SAP\]). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) Based on Investigator Assessment | 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 | 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). | Months | MEDIAN |
| SECONDARY | Time From Randomisation to First Subsequent Therapy or Death (TFST) | Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months) | |||
| SECONDARY | Time From Randomisation to Second Subsequent Therapy or Death (TSST) | Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months) | |||
| SECONDARY | Time From Randomisation to Discontinuation of Treatment or Death (TDT) | Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months | |||
| SECONDARY | Serum Concentration of Durvalumab | PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months) | The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-drug Antibodies (ADA) to Durvalumab | 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) | ADA Analysis Set. This includes all patients who receive at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result. | Number of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | Global Cohort - SoC | 9.6 | 95% Confidence Interval 9.0 to 9.9 | Months | |
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | Global Cohort - SoC + Durvalumab | 10.2 | 95% Confidence Interval 9.7 to 14.7 | Months | |
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | Global Cohort - SoC + Durvalumab + Olaparib | 15.1 | 95% Confidence Interval 12.6 to 20.7 | Months | |
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | China Cohort - SoC | 9.7 | 95% Confidence Interval 7.6 to 12.3 | Months | |
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | China Cohort - SoC + Durvalumab | 9.9 | 95% Confidence Interval 8.2 to 20.6 | Months | |
| Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | China Cohort - SoC + Durvalumab + Olaparib | 9.9 | 95% Confidence Interval 7.1 to 12.6 | Months | |
| Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | Global Cohort - SoC | 19.1 | 95% Confidence Interval 16.4 to 22.9 | Months | |
| Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | Global Cohort - SoC + Durvalumab | 22.2 | 95% Confidence Interval 18.7 to NA | Months | |
| Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | Global Cohort - SoC + Durvalumab + Olaparib | NA | 95% Confidence Interval NA to NA | Months | |
| Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice | China Cohort - SoC | 24.2 | 95% Confidence Interval 15.5 to NA | Months |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Global Cohort | STARTED | Standard of Care (SoC) | 241 | |
| Global Cohort | STARTED | SoC + Durvalumab | 238 | |
| Global Cohort | STARTED | SoC + Durvalumab + Olaparib | 239 | |
| Global Cohort | COMPLETED | Standard of Care (SoC) | 147 | |
| Global Cohort | COMPLETED | SoC + Durvalumab | 159 | |
| Global Cohort | COMPLETED | SoC + Durvalumab + Olaparib | 170 | |
| Global Cohort | NOT COMPLETED | Standard of Care (SoC) | 94 | |
| Global Cohort | NOT COMPLETED | SoC + Durvalumab | 79 | |
| Global Cohort | NOT COMPLETED | SoC + Durvalumab + Olaparib | 69 | |
| China Cohort | STARTED | Standard of Care (SoC) | 44 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,842
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pneumonia | Infections and infestations | Global Cohort - SoC | 1 | 236 | 1 |
| other | Pneumonia | Infections and infestations | Global Cohort - SoC + Durvalumab | 0 | 235 | 0 |
| other | Pneumonia | Infections and infestations | Global Cohort - SoC + Durvalumab + Olaparib | 5 | 238 | 5 |
| other | Pneumonia | Infections and infestations | China Cohort - SoC | 0 | 44 | 0 |
| other | Pneumonia | Infections and infestations | China Cohort - SoC + Durvalumab | 2 | 41 | 2 |
| other | Pneumonia | Infections and infestations | China Cohort - SoC + Durvalumab + Olaparib | 3 | 41 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Global Cohort - SoC | 8 | 236 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | Global Cohort - SoC + Durvalumab | 4 | 235 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Global Cohort - SoC + Durvalumab + Olaparib | 11 | 238 | 12 |
| other | Upper respiratory tract infection | Infections and infestations | China Cohort - SoC | 7 | 44 | 7 |
1 to 10 of 1,842Source ClinicalTrials.gov
See all 1,842 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Global Cohort - SoC | 82 | 241 |
| Total, all-cause mortality | Global Cohort - SoC + Durvalumab | 65 | 238 |
| Total, all-cause mortality | Global Cohort - SoC + Durvalumab + Olaparib | 52 | 239 |
| Total, all-cause mortality | China Cohort - SoC | 12 | 44 |
| Total, all-cause mortality | China Cohort - SoC + Durvalumab | 11 | 43 |
| Total, all-cause mortality | China Cohort - SoC + Durvalumab + Olaparib | 14 | 42 |
| Total, other adverse events | Global Cohort - SoC | 233 | 236 |
| Total, other adverse events | Global Cohort - SoC + Durvalumab | 228 | 235 |
| Total, other adverse events | Global Cohort - SoC + Durvalumab + Olaparib | 236 | 238 |
| Total, other adverse events | China Cohort - SoC | 44 | 44 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04269200
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