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Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

Trial Status: Active

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.

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:
  • Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic 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.
  • 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.

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

California

San Diego
University of California San Diego
Status: ACTIVE
San Francisco
University of California San Francisco
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: APPROVED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: IN_REVIEW

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

This Phase III study will 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.

Target patient population: Adult female patients with histologically confirmed diagnosis of

epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly

diagnosed Stage IV, or recurrent endometrial cancer

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D9311C00001
  • Secondary IDs NCI-2020-04434, 2019-004112-60, ENGOT-EN10, GOG-3041
  • Clinicaltrials.gov ID NCT04269200