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Immune Checkpoint Inhibitor

Durvalumab + Olaparib for Endometrial Cancer (DUO-E Trial)

Phase 3
Waitlist Available
Led By Shannon N. Westin, MD, MPH, FACOG
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FPPE tumor sample must be available for MMR evaluation
Age ≥18 years at the time of screening and female
Must not have
Brain metastases or spinal cord compression
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new combination treatment for endometrial cancer that could potentially improve outcomes and side effects.

Who is the study for?
This trial is for women over 18 with advanced or recurrent endometrial cancer, including carcinosarcomas but not sarcomas. Participants can be newly diagnosed or have a recurrence after at least 12 months since last treatment if previously treated in the adjuvant setting. They must have an ECOG performance status of 0 or 1 and cannot have brain metastases, spinal cord compression, history of leptomeningeal carcinomatosis, prior PARP inhibitors use, or previous immune-mediated therapy.
What is being tested?
The study tests durvalumab combined with chemotherapy (paclitaxel + carboplatin), followed by maintenance durvalumab alone or with olaparib versus placebo in patients with new or recurring endometrial cancer. The goal is to assess how well these treatments work and their safety as maintenance therapy.
What are the potential side effects?
Possible side effects include those related to immunotherapy such as inflammation in various organs, infusion reactions; chemotherapy-related issues like nausea and hair loss; and specific concerns from olaparib which may involve blood cell count changes and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor sample available for a specific genetic test.
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I am a woman aged 18 or older.
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I have been recently diagnosed with Stage IV cancer.
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My cancer is at Stage III and was measured after surgery or biopsy.
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My cancer has come back and cannot be cured by surgery alone.
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My cancer is a type of endometrial carcinoma, not sarcoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain or spinal cord.
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I have previously received immunotherapy, excluding cancer vaccines.
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I have been treated with PARP inhibitors before.
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I have had cancer spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A
Secondary study objectives
Duration of response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+7 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Nausea
17%
Fever
17%
Anorexia
17%
Maculopapular rash
17%
Pruritus
14%
Constipation
14%
Rash maculo-papular
10%
Anemia
10%
Abdominal pain
10%
Itching
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
7%
Cough
7%
Dry Skin
7%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (durvalumab+olaparib)Experimental Treatment4 Interventions
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.
Group II: Arm B (durvalumab+placebo)Experimental Treatment4 Interventions
Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
Group III: Arm A (control)Active Control4 Interventions
Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
durvalumab
2017
Completed Phase 2
~280
Carboplatin
2014
Completed Phase 3
~6120
olaparib
2009
Completed Phase 3
~990
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,121,927 Total Patients Enrolled
10 Trials studying Endometrial Cancer
3,899 Patients Enrolled for Endometrial Cancer
The Gynecologic Oncology Group (GOG) Foundation IncUNKNOWN
The European Network for Gynaecological Oncological Trial groups (ENGOT)UNKNOWN

Media Library

Durvalumab (Immune Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04269200 — Phase 3
Endometrial Cancer Research Study Groups: Arm A (control), Arm C (durvalumab+olaparib), Arm B (durvalumab+placebo)
Endometrial Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04269200 — Phase 3
Durvalumab (Immune Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04269200 — Phase 3
~146 spots leftby Nov 2025
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