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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04269200
Registration number
NCT04269200
Ethics application status
Date submitted
10/02/2020
Date registered
13/02/2020
Date last updated
5/03/2024
Titles & IDs
Public title
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
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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)
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Secondary ID [1]
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GOG-3041
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Secondary ID [2]
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D9311C00001
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Universal Trial Number (UTN)
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Trial acronym
DUO-E
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Neoplasms
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0
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Condition category
Condition code
Cancer
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0
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A
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Assessment method [1]
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Defined as the time from randomisation until the date of objective disease progression (per RECIST 1.1 as assessed by investigator) or death (by any cause in the absence of progression)
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Timepoint [1]
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Up to 4 years
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Secondary outcome [1]
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Second Progression (PFS2)
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Assessment method [1]
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Defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause
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Timepoint [1]
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Up to 6 years
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Defined as the time from randomisation to death due to any cause
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Timepoint [2]
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Up to 6 years
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 4 years
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Secondary outcome [4]
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Duration of response (DoR)
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Assessment method [4]
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Defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression
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Timepoint [4]
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Up to 4 years
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Secondary outcome [5]
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Time to first subsequent therapy (TFST)
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Assessment method [5]
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Defined as the time from randomisation to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment or death due to any cause
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Timepoint [5]
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Up to 6 years
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Secondary outcome [6]
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Time to second subsequent therapy (TSST)
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Assessment method [6]
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Defined as the time from randomisation to the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment or death due to any cause.
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Timepoint [6]
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Up to 6 years
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Secondary outcome [7]
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Time to discontinuation or death (TDT)
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Assessment method [7]
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Defined as the time from randomisation to the earlier of the date of study treatment discontinuation or death.
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Timepoint [7]
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Up to 6 years
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Secondary outcome [8]
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The pharmacokinetics (PK) of durvalumab will be determined after steady state doses
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Assessment method [8]
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Determination of durvalumab concentration in serum
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Timepoint [8]
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Up to 4 years
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Secondary outcome [9]
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Safety and tolerability of drugs by assessment of AEs/SAEs
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Assessment method [9]
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Graded according to the National Cancer Institute (NCI CTCAE)
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Timepoint [9]
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Up to 6 years
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Secondary outcome [10]
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The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab
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Assessment method [10]
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Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum
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Timepoint [10]
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Up to 4 years
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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.
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Minimum age
18
Years
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Maximum age
150
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/05/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
805
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Research Site - Malvern
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Research Site - Melbourne
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Research Site - Nedlands
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Research Site - Sydney
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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NSW 2145 - Sydney
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Recruitment outside Australia
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Japan
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State/province [114]
0
0
Tsu-shi
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Country [115]
0
0
Japan
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State/province [115]
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0
Yokohama-shi
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Country [116]
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0
Korea, Republic of
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State/province [116]
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0
Goyang-si
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Country [117]
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Korea, Republic of
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State/province [117]
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Seoul
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Country [118]
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Korea, Republic of
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State/province [118]
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Suwon
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Country [119]
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Korea, Republic of
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State/province [119]
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Yangsan-si
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Country [120]
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Lithuania
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State/province [120]
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Kaunas
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Country [121]
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Lithuania
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State/province [121]
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Vilnius
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Country [122]
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Mexico
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State/province [122]
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Aguascalientes
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Country [123]
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Mexico
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State/province [123]
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Mexico
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Country [124]
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Mexico
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State/province [124]
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Monterrey
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Country [125]
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Mexico
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State/province [125]
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Oaxaca
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Country [126]
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Mexico
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State/province [126]
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Queretaro
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Country [127]
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Mexico
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State/province [127]
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San Luis Potosi
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Country [128]
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Mexico
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State/province [128]
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Veracruz
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Country [129]
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0
Poland
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State/province [129]
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Gdansk
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Country [130]
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Poland
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State/province [130]
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Lublin
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Country [131]
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Poland
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State/province [131]
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0
Olsztyn
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Country [132]
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Poland
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State/province [132]
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Lódz
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Country [133]
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Russian Federation
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State/province [133]
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0
Anzorey
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Country [134]
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Russian Federation
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State/province [134]
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0
Kazan, Tatarstan
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Country [135]
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Russian Federation
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State/province [135]
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Krasnodar
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Country [136]
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Russian Federation
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State/province [136]
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Moscow
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Country [137]
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Russian Federation
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State/province [137]
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Saransk
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Country [138]
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Russian Federation
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State/province [138]
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Sochi
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Country [139]
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Russian Federation
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State/province [139]
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St. Petersburg
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Country [140]
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Singapore
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State/province [140]
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Singapore
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Country [141]
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Spain
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State/province [141]
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Barcelona
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Country [142]
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Spain
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State/province [142]
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El Palmar
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Country [143]
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Spain
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State/province [143]
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Girona
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Country [144]
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Spain
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State/province [144]
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Jaén
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Country [145]
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Spain
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State/province [145]
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Madrid
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Country [146]
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Spain
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State/province [146]
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0
Mallorca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
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The Gynecologic Oncology Group (GOG) Foundation Inc
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Address [1]
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0
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0
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Other collaborator category [2]
0
0
Other
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Name [2]
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The European Network for Gynaecological Oncological Trial groups (ENGOT)
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Address [2]
0
0
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Country [2]
0
0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04269200
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Shannon N. Westin, MD, MPH, FACOG
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Address
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The University of Texas MD Anderson Cancer Center
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04269200
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