BENITIONSClinical Trial Intelligence

Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

2상 진행 중(모집 완료) NCT04739800

대상 질환Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Platinum-Refractory Fallopian Tube Carcinoma, Platinum-Refractory Ovarian Carcinoma
임상 단계2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수120 명
중재(약물)Biospecimen Collection, Cediranib Maleate, Computed Tomography, Computed Tomography with Contrast, Durvalumab
시작일2021년 6월 10일
완료일2023년 1월 26일
결과 공개일2024년 6월 18일

요약

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
Arm II (Durvalumab, Cediranib Maleate, Olaparib)2.6 Months
Arm III (Durvalumab, Cediranib Maleate)2.3 Months
Arm IV (Cediranib Maleate, Olaparib)2.3 Months
Hazard Ratio (HR)1.00 (95% CI 0.44–2.31)

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