NCT04269200 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · NOT POSTED

Overall Survival (OS) Analysis

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outcome · POSTED

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

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outcome · POSTED

Objective Response Rate (ORR) Based on Investigator Assessment

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outcome · POSTED

Duration of Response (DoR) Based on Investigator Assessment

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outcome · NOT POSTED

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

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outcome · NOT POSTED

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

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outcome · NOT POSTED

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

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outcome · POSTED

Serum Concentration of Durvalumab

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outcome · POSTED

Anti-drug Antibodies (ADA) to Durvalumab

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outcome · POSTED

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)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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: * 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.
gender Based: true
gender Description: Female subjects only
healthy Volunteers: false
maximum Age: 150 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
intervention Names
Drug: durvalumab placebo
Drug: olaparib placebo
Drug: Carboplatin
Drug: Paclitaxel
label
Arm A (control)
type
ACTIVE_COMPARATOR
description
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
intervention Names
Biological: durvalumab
Drug: olaparib placebo
Drug: Carboplatin
Drug: Paclitaxel
label
Arm B (durvalumab+placebo)
type
EXPERIMENTAL
description
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.
intervention Names
Drug: olaparib
Biological: durvalumab
Drug: Carboplatin
Drug: Paclitaxel
label
Arm C (durvalumab+olaparib)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm C (durvalumab+olaparib)
description
Olaparib tablets
name
olaparib
type
DRUG
arm Group Labels
Arm B (durvalumab+placebo)
Arm C (durvalumab+olaparib)
description
Durvalumab by intravenous infusion
name
durvalumab
type
BIOLOGICAL
arm Group Labels
Arm A (control)
description
Matching placebo for intravenous infusion
name
durvalumab placebo
type
DRUG
arm Group Labels
Arm A (control)
Arm B (durvalumab+placebo)
description
Placebo tablets to match olaparib
name
olaparib placebo
type
DRUG
arm Group Labels
Arm A (control)
Arm B (durvalumab+placebo)
Arm C (durvalumab+olaparib)
description
Standard of care chemotherapy
name
Carboplatin
type
DRUG
arm Group Labels
Arm A (control)
Arm B (durvalumab+placebo)
Arm C (durvalumab+olaparib)
description
Standard of care chemotherapy
name
Paclitaxel
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

double-blind, placebo-controlled

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 805
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

description
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
measure
Overall Survival (OS) Analysis
time Frame
Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months
description
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
measure
Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice
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
description
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
measure
Objective Response Rate (ORR) Based on Investigator Assessment
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
description
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
measure
Duration of Response (DoR) Based on Investigator Assessment
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
description
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
measure
Time From Randomisation to First Subsequent Therapy or Death (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)
description
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
measure
Time From Randomisation to Second Subsequent Therapy or Death (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)
description
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
measure
Time From Randomisation to Discontinuation of Treatment or Death (TDT)
time Frame
Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months
description
To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib
measure
Serum Concentration of Durvalumab
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)
description
To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib
measure
Anti-drug Antibodies (ADA) to Durvalumab
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)
description
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.
measure
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)
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.
description
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.
measure
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
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.

Full study description

brief 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.
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

Source references

references

citation
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41943281
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pmid
40590327
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citation
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pmid
37864337
type
DERIVED