ENDOMETRIAL: METASTATIC: 1st Line: DUO-E

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)

Title
AstraZeneca D9311C00001 (Endometrial 1st line + maintanance)
Study 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)

Site Link
Malignancy
Endometrial cancer, uterine cancer
Stage
Disease Setting
Recurrent/Metastatic
Line Of Therapy
1st Line + maintenance
Investigational Agent
Durvalumab + olaparib
Drug Class
PD-L1 inhibitor, PARP inhibitor
PI
Adam ElNaggar, MD
Sponsor
AstraZeneca
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Female age 18 or greater
  • Histologicall confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcoma, are allowed
  • Disease in one of the following categories
    • Newly diagnosed Stage III disease (with measurable disease following surgery or biopsy)
    • Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
    • Recurrence of disease where the potential for cure by surgery alone or in combination is poor
  • Naive to first line systemic anti-cancer treatment.  For patients with recurrent disease only, prior chemo is allowed only if administered in the adjuvant setting and there is at least 12 months from the date of the last dose of chemo to the date of subsequent relapse
  • ECOG PS 0-1
  • No CNS disease
  • No prior treatment with PARP inhibitors or immunotherapy
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • PFS2
    • ORR
    • DoR
    • TFST
    • TSST
    • TDT
    • PK
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Epithelial endometrial carcinoma, carcinosarcoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
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