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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04269200
Ethics application status
Date submitted
10/02/2020
Date registered
13/02/2020
Date last updated
23/11/2020

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
2019-004112-60
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
Other interventions - 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

Other interventions: 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
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)
Timepoint [1] 0 0
upto to 4 years
Secondary outcome [1] 0 0
Overall Survival (OS) - Defined as the time from randomisation to death due to any cause
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Second Progression (PFS2) - Defined as time from randomisation to the earliest of the progression event subsequent to first subsequent therapy or death
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) - Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site.
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Duration of response (DoR) - Defined as the time from the date of first documented confirmed response (CR/PR) until the first progression or death in the absence of disease progression
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to first subsequent therapy (TFST) - Time elapsed from randomisation to first subsequent therapy or death
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
Time to second subsequent therapy (TSST) - Time elapsed from randomisation to second subsequent therapy or death
Timepoint [6] 0 0
Up to 6 years
Secondary outcome [7] 0 0
Time to discontinuation or death (TDT) - Time elapsed from randomisation to study treatment discontinuation or death
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 - Determination of durvalumab concentration in serum
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Safety and tolerability of drugs by assessment of AEs/SAEs - Graded according to the National Cancer Institute (NCI CTCAE)
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 - Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum
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 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 chemotherapy is allowed only if it was administered in the
adjuvant setting and there is at least 12 months from date of last dose of
chemotherapy 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
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of leptomeningeal carcinomatosis.

- Brain metastases or spinal cord compression.

- Prior treatment with PARP inhibitors.

- Prior immune checkpoint inhibitors or prior treatment with an agent directed to a

stimulatory or co-inhibitor T-cell receptor other than anti-PD-1, anti-PD-L1, or anti-PD-L2
agent.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment hospital [6] 0 0
Research Site - Port Macquarie
Recruitment hospital [7] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [7] 0 0
NSW 2145 - Sydney
Recruitment outside Australia
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Seoul
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Suwon
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Lithuania
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Vilnius
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Ciudad de Mexico
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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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Olsztyn
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Lódz
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Russian Federation
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Anzorey
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Chelyabinsk
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Kazan, Tatarstan
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Krasnodar
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Moskva
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Sochi
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St Petersburg
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St. Petersburg
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Singapore
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Singapore

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
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.
Trial website
https://clinicaltrials.gov/show/NCT04269200
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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04269200