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

NCT04269200

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Endometrial Neoplasms

Interventions: olaparib, durvalumab, durvalumab placebo, olaparib placebo, Carboplatin

Countries: United States, Australia, Belgium, Brazil, Canada, China, Colombia, Estonia

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 overview

Sex: FEMALE

Age: 18 Years to 150 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (201)

Tucson, Arizona, United States
Concord, California, United States
La Jolla, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Aurora, Colorado, United States
Fort Lauderdale, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Jackson, Mississippi, United States
Lebanon, New Hampshire, United States
Camden, New Jersey, United States
Paramus, New Jersey, United States
New York, New York, United States
New York, New York, United States
Pinehurst, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
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