Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
2상
진행 중(모집 완료)
NCT04034927
| 대상 질환 | Fallopian Tube Endometrioid Tumor, Fallopian Tube High Grade Serous Adenocarcinoma, Malignant Ovarian Endometrioid Tumor, Ovarian High Grade Serous Adenocarcinoma |
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| 임상 단계 | 2상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 61 명 |
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| 중재(약물) | Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib, Tremelimumab |
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| 시작일 | 2019년 12월 4일 |
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| 완료일 | 2021년 7월 31일 |
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| 결과 공개일 | 2023년 10월 13일 |
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요약
This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.
Progression Free Survival (PFS)
PFS is monitored for progression or death due to any cause, whichever occurs first. The median follow-up time is 22 months. Since the study was stopped early, the follow-up for progression-free survival was significantly reduced. · Participants
| Arm I (Olaparib) | 24 Participants |
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| Arm II (Olaparib, Tremelimumab) | 23 Participants |
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Dose-limiting Toxicity (DLT) (Safety Lead-In)
At least 4 weeks after initiating treatment, no longer than 12 weeks (three complete treatment cycles). Maximum follow-up was 12 weeks. · Participants
| Arm I (Olaparib) | 0 Participants |
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| Arm II (Olaparib, Tremelimumab) | 6 Participants |
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