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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

DUO-E 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.Check my eligibility

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.See study design

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.

DUO-E Trial 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.

DUO-E Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A

Secondary outcome measures

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%

Pruritus

17%

Maculopapular rash

17%

Anorexia

17%

Nausea

17%

Fever

14%

Rash maculo-papular

14%

Constipation

10%

Itching

10%

Anemia

10%

Abdominal pain

Cough

Dry Skin

Dehydration

Hypothyroidism

Non-cardiac chest pain

Weight loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

DUO-E 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

~400

Carboplatin

2014

Completed Phase 3

~6670

olaparib

2009

Completed Phase 3

~690

Paclitaxel

2011

Completed Phase 4

~5380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,097 Total Patients Enrolled

11 Trials studying Endometrial Cancer

3,950 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the age restrictions for this trial top out at 80 years or above?

"The age limit for this clinical trial is 150 years old. All candidates must also be of legal adult age, which is 18 years or older in most jurisdictions."

Answered by AI

For what type of patient does durvalumab usually provide relief?

"durvalumab is an immunotherapy medication used to treat various forms of cancer like non-small cell lung carcinoma, as well as for allogeneic stem cell transplantation therapy."

Answered by AI

To what extent has durvalumab been studied in other research projects?

"There are a total of 1623 clinical trials being conducted that involve durvalumab. Of these, 390 are Phase 3 studies. The largest concentration of these research sites is in Shanghai, but there are 80240 locations running these kinds of tests worldwide."

Answered by AI

Are people still being accepted into this clinical trial?

"Yes, according to the website clinicaltrials.gov, which is managed by the U.S. National Library of Medicine, this study is still looking for patients and is therefore actively recruiting participants."

Answered by AI

Have there been any legal hurdles in the way of durvalumab's therapeutic use?

"Durvalumab has been studied extensively and is considered safe, with a Power team estimate of 3 on a 1-3 scale."

Answered by AI

For whom would this trial be an appropriate fit?

"This clinical trial is looking for 699 patients with endometrial neoplasms that meet the following 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., Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy), Recurrence of disease (measurable or non-measurable disease per RECIST"

Answered by AI

What goals does this medical study hope to attain?

"The success of this long-term study will be primarily evaluated by measuring Progression Free Survival (PFS) over the course of 4 years. Additionally, researchers will also track Overall Survival (OS), Safety and tolerability of drugs by assessment of AEs/SAEs, and Duration of response (DoR)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04269200.

All > Endometrial Cancer