Effect of Durvalumab and/or Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

Phase 3

• Conditions: Health Condition 1: C55- Malignant neoplasm of uterus, partunspecified

• Registration Number: CTRI/2021/07/034833
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Capable of giving signed informed consent;

2) Histologically confirmed diagnosis of epithelial endometrial carcinoma;

3) Patient must have endometrial cancer in categories as specified in protocol;

4) Naïve to first-line systemic anti-cancer treatment;

5) A formalin-fixed, paraffin-embedded (FFPE) tumour sample from the locoregional or a metastatic site must be available and must be suitable for mismatch repair (MMR) status evaluation;

6) Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment;

7) Must have a life expectancy of at least 16 weeks;

8) Postmenopausal or evidence of nonchildbearing status for women of childbearing potential;

9) Body weight >30 kg;

10) Adequate organ and bone marrow function within 28 days prior to administration of Cycle 1 Day 1 as defined in protocol;

11) Measured creatinine clearance (CrCL) or calculated creatinine clearance (CrCL) within range specified in protocol

Exclusion Criteria

1) Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE version 5.0) Grade 2 and above from previous anticancer therapy;

2) 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;

3) History of allogenic organ transplantation;

4) Previous allogenic bone marrow transplant or double umbilical cord blood transplantation;

5) Active or prior documented autoimmune or inflammatory disorders;

6) Uncontrolled intercurrent illness 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;

7) History of another primary malignancy;

8) History of leptomeningeal carcinomatosis;

9) Brain metastases or spinal cord compression;

10) Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as

judged by the investigator or patients with congenital long QT syndrome;

11) History of active primary immunodeficiency;

12) Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus;

13) Myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML;

14) Prior/concomitant therapy, prior/concurrent clinical study experience and other exclusions as specified in protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) (per RECIST 1.1 as assessed by investigator)Timepoint: Q9W for the first 18 weeks relative to randomisation and then Q12W until RECIST 1.1-defined radiological progression (PD)