Study on Durvalumab with Chemotherapy and Bevacizumab, Followed by Maintenance Treatment for Advanced Ovarian Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03737643
This clinical trial is testing a combination of treatments, including durvalumab, chemotherapy, and bevacizumab, followed by maintenance therapy with durvalumab, bevacizumab, and olaparib, to see if they can help patients with advanced ovarian cancer live longer without the cancer returning or worsening.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is designed to evaluate the effectiveness and safety of a treatment plan for patients with newly diagnosed advanced ovarian cancer. The plan includes a combination of durvalumab, standard chemotherapy, and bevacizumab, followed by maintenance therapy with either bevacizumab alone, or in combination with durvalumab, or with both durvalumab and olaparib. The goal is to determine which combination helps patients live longer without the cancer coming back or getting worse, and to assess the impact on patients' quality of life.
Description
Patients eligible for this study are those newly diagnosed with advanced ovarian, primary peritoneal, or fallopian-tube cancer. They should be candidates for surgery to remove as much of the cancer as possible, either immediately after diagnosis or after starting chemotherapy. The study will test the effectiveness and safety of combining standard chemotherapy and bevacizumab with durvalumab, followed by maintenance therapy with bevacizumab alone, or with durvalumab, or with both durvalumab and olaparib. The aim is to find out which treatment combination helps patients live longer without the cancer returning or worsening, and to understand how these treatments affect patients' quality of life.
Eligibility Criteria
Inclusion Criteria
- Women with newly diagnosed advanced ovarian, primary peritoneal, or fallopian-tube cancer.
- Must be 18 years or older (20 years or older in Japan).
- Candidates for surgery to remove cancer, either before or after starting chemotherapy.
- Must provide a tumor sample for BRCA testing.
- Good overall health with an ECOG performance status of 0 or 1.
- Must have good organ and bone marrow function.
- Postmenopausal or not able to have children, confirmed by a negative pregnancy test.
Exclusion Criteria
- Non-epithelial ovarian cancer or certain low-grade tumors.
- Previous treatment for ovarian cancer.
- Unable to determine BRCA mutation status.
- Previous treatment with PARP inhibitors or immune therapies.
- Planned chemotherapy directly into the abdomen.
- Active or past autoimmune or inflammatory disorders.
- Serious uncontrolled illnesses or significant heart disease.
- Known brain metastases.
- History of another cancer unless treated and inactive for 5 years, or certain low-risk cancers.
- Ongoing severe side effects from previous cancer treatments.
- Allergies to study drugs or their components.
- Breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 92610 | Foothill Ranch | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92868-3298 | Orange | California |
| Research Site | 94158 | San Francisco | California |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 30912 | Augusta | Georgia |
| Research Site | 60521 | Hinsdale | Illinois |
| Research Site | 46202 | Indianapolis | Indiana |
| Research Site | 21204 | Towson | Maryland |
| Research Site | 48202 | Detroit | Michigan |
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