Study ID: NRG-GY023
Comparison of immunotherapy drug combinations for ovarian and other gynecological cancers
This trial will compare various immunotherapy drug combinations for treating ovarian, peritoneal and fallopian tube cancer. The drugs under study are durvalumab [Imfinzi], olaparib [Lynparza] and cediranib. Patients will be randomly selected to receive one of three drug combinations or chemotherapy.
To assess the efficacy of various drug combinations durvalumab as measured by progression-free survival, as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab. Under examination are durvalumab plus olaparib and cediranib. Other combinations are cediranib plus either durvalumab or olaparib.
Must have recurrent/persistent platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers; platinum-resistant disease is defined as progression within < 6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy.
- At least two prior treatment regimens (including primary therapy) but up to 5 lines of systemic anticancer therapy. Hormonal therapy (such as tamoxifen, aromatase inhibitors) will not count as a previous treatment regimen.
- Prior use of bevacizumab in the upfront or recurrent setting is required.
- Prior use of PARP inhibitor is allowed.
- Prior use of immune checkpoint blockade (e.g., a PD-L1/PD-1inhibitor or a CTLA-4 inhibitor) is allowed.
- Must have ovarian, peritoneal or fallopian tube cancer that has recurred or proven resistant to therapy
- Must have received 2 to 5 anticancer therapies (excluding hormonal therapy)
- Must have been previously treated with bevacizumab [Avastin]