Study on Durvalumab With or Without Olaparib as Maintenance Therapy After Initial Treatment for Advanced and Recurrent Endometrial Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04269200
This clinical trial is evaluating the effectiveness and safety of using durvalumab, with or without olaparib, as a follow-up treatment after initial chemotherapy for women with advanced or returning endometrial cancer.
Patient Parameters
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Program Overview
The purpose of this study is to determine if the drug durvalumab, used alone or with another drug called olaparib, can help control advanced or recurrent endometrial cancer after initial treatment with chemotherapy drugs paclitaxel and carboplatin. The study aims to assess how well these treatments work and how safe they are for patients.
Description
This Phase III clinical trial is testing the effectiveness and safety of using durvalumab, with or without olaparib, as a maintenance treatment after initial chemotherapy for women with advanced or recurrent endometrial cancer. The study involves adult women who have been newly diagnosed with advanced stages of endometrial cancer or have cancer that has returned. Participants will first receive chemotherapy with paclitaxel and carboplatin, followed by durvalumab alone or in combination with olaparib to see if it helps control the cancer.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older.
- Diagnosed with epithelial endometrial carcinoma, including carcinosarcomas, but not sarcomas.
- Cancer must be in one of the following stages:
- Newly diagnosed Stage III with measurable disease after surgery or biopsy.
- Newly diagnosed Stage IV, with or without measurable disease after surgery or biopsy.
- Recurrent cancer that cannot be cured by surgery alone.
- Must not have received prior systemic anti-cancer treatment, except in certain cases of recurrent cancer where previous treatment was given as adjuvant therapy and at least 12 months have passed since the last treatment.
- Must provide a tumor sample for specific testing.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- History of cancer spreading to the membranes surrounding the brain or spinal cord.
- Cancer that has spread to the brain or caused spinal cord compression.
- Previous treatment with PARP inhibitors.
- Previous treatment with immune therapies, such as anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, except for cancer vaccines.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 94520-2278 | Concord | California |
| Research Site | 92093 | La Jolla | California |
| Research Site | 94158 | San Francisco | California |
| Research Site | 93105 | Santa Barbara | California |
| Research Site | 80012 | Aurora | Colorado |
| Research Site | 33316 | Fort Lauderdale | Florida |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 31404 | Savannah | Georgia |
| Research Site | 96826 | Honolulu | Hawaii |
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