Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
Phase 2
Active, not recruiting
NCT04739800
| Condition | Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Platinum-Refractory Fallopian Tube Carcinoma, Platinum-Refractory Ovarian Carcinoma |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 120 participants |
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| Interventions | Biospecimen Collection, Cediranib Maleate, Computed Tomography, Computed Tomography with Contrast, Durvalumab |
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| Start date | Jun 10, 2021 |
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| Completion date | Jan 26, 2023 |
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| Results posted | Jun 18, 2024 |
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Summary
This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and
Progression Free Survival
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 4.8 months (Inter-Quartile Range: 2.0-7.9 months). · Months
| Arm I (Paclitaxel, Doxorubicin, Topotecan Hydrochloride)) | 4.2 Months |
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| Arm II (Durvalumab, Cediranib Maleate, Olaparib) | 2.6 Months |
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| Arm III (Durvalumab, Cediranib Maleate) | 2.3 Months |
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| Arm IV (Cediranib Maleate, Olaparib) | 2.3 Months |
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| Hazard Ratio (HR) | 1.00 (95% CI 0.44–2.31) |
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Open in BENITIONS
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