AzTrials
AzTrials

Advanced or Recurrent Endometrial CancerPhase 3DUoENDENCT06746116

A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain

A Phase 3 study testing Durvalumab + Chemotherapy phase and Durvalumab + Olaparib phase in people with Advanced or Recurrent Endometrial Cancer, run by AstraZeneca at 24 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase IIIb, interventional, single arm, multicentre study assessing the safety profile of durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC as the primary endpoint. Read more about this study

Who is it for?
Ages 18 to 130 years, women only
Conditions the study is for
Advanced or Recurrent Endometrial Cancer
What is being tested?
Durvalumab + Chemotherapy phase and Durvalumab + Olaparib phase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
24 sitesSpain
Study dates
30 Dec 2024to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease characteristics 3. Histologically confirmed diagnosis of endometrial carcinoma (all histologies, including carcinosarcoma) with archival or recent biopsy available to send at study entry.
  • 4. Only patients with pMMR tumors are allowed (mismatch repair status determined locally per current clinical practice).
  • 5. Patients must have endometrial cancer in one of the following categories:
  • Newly diagnosed Stage III disease classified by FIGO 2023 with mesurable disease per RECIST 1.1 following surgery or diagnostic biopsy.
  • Newly diagnosed Stage IV disease classified by FIGO 2023. Patients with primary cytoreduction without residual disease are allowed.
  • Recurrence of disease where the potential for cure by surgery alone or in combination is poor.
Show all 21Show fewer
  • 6. Naïve to first-line systemic anti-cancer treatment. For patients with recurrent disease, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting (for patients with FIGO 2023 stage II, III or IVA) and there is at least 6 months from date of last dose of adjuvant systemic treatment to date of subsequent relapse.
  • 7.At least one, but ideally two FFPE tumour sample block must be available and must be suitable for NGS and IHC evaluation by central lab. Preferably from primary endometrial tumor, but also from metastatic site will be allowed if there is no primary tumor block available. Tumor tissue has to have no less than 30% tumoral cell and tumoral area size has to be no less than 0,5cm2.
  • 8.Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status ≤ 2 at enrolment.
  • Note: not more than 20% of patients with ECOG PS2 will be allowed; once this limit is met, additional enrolled patients must have PS <2.
  • Reproductive status 9.Postmenopausal or evidence of nonchildbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of Cycle 1 Day 1 and confirmed prior to treatment on Cycle 1 Day 1. Women will be considered post- menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments, and if they have LH and FSH levels in the post- menopausal range for the institution.
  • Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago.
  • Women who are surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible.
  • Organ function 10.Adequate organ and bone marrow function, defined as:
  • Haemoglobin ≥10.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L
  • Platelet count ≥100 × 109/L
  • Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN.
  • 11.Measured creatinine clearance (CrCL) >51 mL/min or calculated CrCL >51 mL/min as determined by Cockcroft-Gault (using actual body weight), a 24-hour urine test or another validated test as per local practice: Estimated CrCL = (140-age [years]) × weight (kg) × 0.85 (mL/min) 72 × serum creatinine (mg/dL)

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical history
  • Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE version 5.0) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Note:
  • -Patients with Grade ≥2 neuropathy may be included only after consultation with the study physician.
  • -Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the study physician.
  • Uterine sarcomas will not be allowed.
Show all 47Show fewer
  • Major surgical procedure (as defined by the investigator) within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Note: Local surgery of isolated lesions for palliative intent is acceptable or diagnostic staging.
  • History of allogenic organ transplantation.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • -Patients with vitiligo or alopecia.
  • -Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
  • -Any chronic skin condition that does not require systemic therapy.
  • -Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
  • -Patients with coeliac disease controlled by diet alone.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension (systolic blood pressure >160 mmHg; diastolic blood pressure >100 mmHg), unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy except for:
  • -Malignancy treated with curative intent and with no known active disease.
  • -≥5 years before the first dose of IP and of low potential risk for recurrence.
  • -Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • History of leptomeningeal carcinomatosis.
  • Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a magnetic resonance imaging (MRI) (preferred) or computed tomography (CT) each preferably with IV contrast of the brain prior to study entry.
  • Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischaemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation ≥500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
  • History of active primary immunodeficiency.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HbsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML.
  • Prior/concomitant therapy
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  • 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.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Prior hormonal therapy for cancer treatment must be stopped at least 7 days prior to first dose of study treatment.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
  • Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
  • Concomitant use of known strong (e.g., phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for phenobarbital and 3 weeks for other agents.
  • Other exclusions
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Unable to swallow orally administered medication.
  • Any gastrointestinal disorder likely to interfere with absorption of the study medication.
  • Pregnant or breastfeeding.
  • Patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after last dose of study intervention or 6 months after the last dose of olaparib, whichever is later.
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Spain24 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Alicante, 03010

  • Research Site

    Barakaldo, 48903

  • Research Site

    Barcelona, 08035

  • Research Site

    Córdoba, 14004

  • Research Site

    El Palmar, 30120

  • Research Site

    Girona, 17007

  • Research Site

    L'Hospitalet de Llobregat, 08908

  • Research Site

    Las Palmas de Gran Canaria, 35016

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28041

  • Research Site

    Madrid, 28046

  • Research Site

    Madrid, 28807

  • Research Site

    Málaga, 29010

  • Research Site

    Pamplona, 31008

  • Research Site

    Salamanca, 37007

  • Research Site

    San Sebastián, 20014

  • Research Site

    Santander, 39008

  • Research Site

    Seville, 41013

  • Research Site

    Valencia, 46009

  • Research Site

    Valencia, 46010

  • Research Site

    Valencia, 46026

  • Research Site

    Vigo, 36312

  • Research Site

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: A Phase IIIB Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Patients With Newly Diagnosed pMMR Advanced or Recurrent Endometrial Cancer in Spain

This is a phase IIIb, interventional, single arm, multicentre study assessing the safety profile of durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC as the primary endpoint.

The study will include approximately 85 patients distributed in approximately 20 sites in Spain.

Read more

The planned duration of patient recruitment is approximately 12 months. Each patient will be followed up from screening for 36 months, until end of study period, death, withdrawal from study or loss to follow-up; whichever occurs first.

Enrolment will be opened to all eligible patients treated with durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC. In addition, adequate tumour tissue before study entry, stool and blood sample collected will be required for central analysis to monitor the status of relevant biomarkers.

Read the detailed description

The purpose of this study is to describe the safety profile of durvalumab in combination with platinum-based chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR advanced or recurrent endometrial cancer.

Study population: Approximately 85 eligible patients with newly diagnosed pMMR advanced or recurrent endometrial cancer (aEC) will be enrolled into the study distributed in approximately 20 sites in Spain.

Study details include:

  • The recruitment period will be approximately 12 months.
  • The study duration will be approximately 48 months (12 months recruitment period + 36 months treatment and follow-up).
  • The median treatment duration will be approximately 13 months based on treatment duration for durvalumab + olaparib in DUO-E (22) (until objective radiological disease progression, unacceptable toxicity, consent withdrawal or death). Those patients in complete response will be allowed to discontinue durvalumab plus olaparib after completing 2 years in the maintenance phase.
  • The analysis for the primary objective is planned to be conducted 12 months after LSI to allow all patients have had the opportunity for 12 months of follow up, and at the end of the follow-up of the last patient up to 36 months.
  • The visit frequency will be: oChemotherapy Phase: every 21 days (every cycle). oMaintenance Phase: every 28 days (every cycle)

Treatment:

  • Durvalumab + Chemotherapy phase: Durvalumab (IV) with SoC (carboplatin + paclitaxel chemotherapy: patients should receive at least 4, but preferably 6 cycles) every three weeks.
  • Durvalumab + Olaparib phase: durvalumab (IV) with olaparib (tablets) every four weeks until progression.
Being tested
Durvalumab + Chemotherapy phase, Durvalumab + Olaparib phase
Keywords
Durvalumab, Olaparib, pMMR, Endometrial cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durvalumab + Chemotherapy phaseDrug

    Also called Chemotherapy phase

    Durvalumab (IV) with SoC (carboplatin + paclitaxel chemotherapy: patients should receive at least 4, but preferably 6 cycles) every three weeks.

  • Durvalumab + Olaparib phaseDrug

    Also called Maintenance phase

    durvalumab (IV) with olaparib (tablets) every four weeks until progression.

Study groups in NCT06746116
Study groupRoleWhat they receive
Single ArmExperimentalDurvalumab + Chemotherapy (chemotherapy phase) plus Durvalumab + Olaparib (maintenence phase)
Receives: Drug: Durvalumab + Chemotherapy phase; Drug: Durvalumab + Olaparib phase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Adverse Events

    Safety and tolerability will be evaluated in terms of Adverse Events (AEs), Serious AEs (SAEs), and immune-mediated AEs (imAEs)

    Measured: Time from enrollment up to at least 90 days after last dose of study treatment

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    Defined as the time from the date of first dose of treatment until the date of objective disease progression or death (by any cause in the absence of progression). The measure of interest is the median PFS.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  2. Objective Response Rate (ORR)

    Defined as the percentage of patients with a confirmed investigator-assessed response of CR or PR and will be based on a subset of all included patients with measurable disease at baseline per the site investigator.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  3. Duration of Response (DoR)

    Defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  4. Overall Survival (OS)

    Defined as the time from the date of first dose of treatment2 until death from any cause.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  5. Change in EORTC QLQ-C30 score

    Change from baseline (enrollment) in EORTC QLQ-C30 score every 12 weeks until end of treatment or disease progression.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  6. Change in EORTC QLQ-EN24 score

    Change from baseline (enrollment) in EORTC QLQ-EN24 score every 12 weeks until end of treatment or disease progression.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

  7. Clinically meaningful deterioration

    Percentage of patients having absolute change in EORTC-QLQ-C30 and EORTC-QLQ-EN24 score from baseline of ≥10 at 6, 12, 24 and 36 months after LSI.

    Measured: From date of enrollment through to disease progression, death, withdrawn from study, or end of study (approximately 48 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start30 Dec 2024
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase IIIb, interventional, single arm, multicentre study.
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746116
Sponsor's protocol ID
D9311L00001
Acronym
DUoENDE
Status last verified
Jul 2026
First submitted
28 Nov 2024
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab + Chemotherapy phase and Durvalumab + Olaparib phase in people with Advanced or Recurrent Endometrial Cancer, run by AstraZeneca at 24 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Adverse Events (time frame: Time from enrollment up to at least 90 days after last dose of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06746116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in