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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04269200




Registration number
NCT04269200
Ethics application status
Date submitted
10/02/2020
Date registered
13/02/2020

Titles & IDs
Public title
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Scientific title
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
Secondary ID [1] 0 0
GOG-3041
Secondary ID [2] 0 0
D9311C00001
Universal Trial Number (UTN)
Trial acronym
DUO-E
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - olaparib
Treatment: Other - durvalumab
Treatment: Drugs - durvalumab placebo
Treatment: Drugs - olaparib placebo
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Active comparator: Arm A (control) - Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).

Experimental: Arm B (durvalumab+placebo) - Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo

Experimental: Arm C (durvalumab+olaparib) - Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.


Treatment: Drugs: olaparib
Olaparib tablets

Treatment: Other: durvalumab
Durvalumab by intravenous infusion

Treatment: Drugs: durvalumab placebo
Matching placebo for intravenous infusion

Treatment: Drugs: olaparib placebo
Placebo tablets to match olaparib

Treatment: Drugs: Carboplatin
Standard of care chemotherapy

Treatment: Drugs: Paclitaxel
Standard of care chemotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Second Progression (PFS2)
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to first subsequent therapy (TFST)
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
Time to second subsequent therapy (TSST)
Timepoint [6] 0 0
Up to 6 years
Secondary outcome [7] 0 0
Time to discontinuation or death (TDT)
Timepoint [7] 0 0
Up to 6 years
Secondary outcome [8] 0 0
The pharmacokinetics (PK) of durvalumab will be determined after steady state doses
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Safety and tolerability of drugs by assessment of AEs/SAEs
Timepoint [9] 0 0
Up to 6 years
Secondary outcome [10] 0 0
The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab
Timepoint [10] 0 0
Up to 4 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
150 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
Accrual to date
Final
805
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Malvern
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
NSW 2145 - Sydney
Recruitment outside Australia
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United States of America
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Arizona
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California
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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New York
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North Carolina
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Ohio
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Oklahoma
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Wisconsin
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Belgium
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Bruges
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Bruxelles
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Hadera
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Korea, Republic of
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Seoul
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Suwon
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Yangsan-si
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Mexico
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Aguascalientes
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Mexico
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Mexico
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Mexico
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Monterrey
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Oaxaca
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Queretaro
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San Luis Potosi
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Veracruz
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Poland
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Gdansk
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Lublin
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Lódz
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Russian Federation
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Anzorey
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Russian Federation
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Kazan, Tatarstan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Saransk
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Sochi
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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El Palmar
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Girona
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Jaén
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Madrid
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Spain
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Mallorca

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Gynecologic Oncology Group (GOG) Foundation Inc
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The European Network for Gynaecological Oncological Trial groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shannon N. Westin, MD, MPH, FACOG
Address 0 0
The University of Texas MD Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04269200