durvalumab placebo: Matching placebo for intravenous infusion
olaparib placebo: Placebo tablets to match olaparib
Carboplatin: Standard of care chemotherapy
Paclitaxel: Standard of care chemotherapy
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
150 Years
Healthy volunteers
No
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.
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.
Primary outcome measure(s)
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments — At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
Trial sites (201)
Facility
City
Region
Status
Research Site
Tucson
Arizona
Research Site
Concord
California
Research Site
La Jolla
California
Research Site
San Francisco
California
Research Site
Santa Barbara
California
Research Site
Aurora
Colorado
Research Site
Fort Lauderdale
Florida
Research Site
Tampa
Florida
Research Site
Savannah
Georgia
Research Site
Honolulu
Hawaii
Research Site
Arlington Heights
Illinois
Research Site
Chicago
Illinois
Research Site
Indianapolis
Indiana
Research Site
Louisville
Kentucky
Research Site
Baton Rouge
Louisiana
Research Site
Boston
Massachusetts
Research Site
Saint Paul
Minnesota
Research Site
Jackson
Mississippi
Research Site
Lebanon
New Hampshire
Research Site
Camden
New Jersey
Research Site
Paramus
New Jersey
Research Site
New York
New York
Research Site
New York
New York
Research Site
Pinehurst
North Carolina
Research Site
Cleveland
Ohio
Research Site
Cleveland
Ohio
Research Site
Dayton
Ohio
Research Site
Oklahoma City
Oklahoma
Research Site
Tulsa
Oklahoma
Research Site
Eugene
Oregon
Research Site
Tigard
Oregon
Research Site
Pittsburgh
Pennsylvania
Research Site
Providence
Rhode Island
Research Site
Sioux Falls
South Dakota
Research Site
Chattanooga
Tennessee
Research Site
Germantown
Tennessee
Research Site
Knoxville
Tennessee
Research Site
Bedford
Texas
Research Site
Dallas
Texas
Research Site
Houston
Texas
+ 161 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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