Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
第2/3相
実施中(募集終了)
NCT02839707
| 対象疾患 | Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma |
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| 相 | 第2/3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 444 名 |
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| 介入(薬剤) | Atezolizumab, Bevacizumab, Computed Tomography, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment |
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| 開始日 | 2017年6月23日 |
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| 完了日 | 2023年5月9日 |
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| 結果公開日 | 2025年3月4日 |
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概要
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens
Up to 28 days · Participants
| Arm I (PLD, Atezolizumab) | 0 Participants |
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| Arm II (PLD, Bevacizumab, Atezolizumab) | 0 Participants |
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| Arm III (PLD, Bevacizumab) | 0 Participants |
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Progression Free Survival (PFS) (Phase II)
From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years · months
| Arm I (PLD, Atezolizumab) | 4.2 months |
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| Arm II (PLD, Bevacizumab, Atezolizumab) | 7.6 months |
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| Arm III (PLD, Bevacizumab) | 5.5 months |
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PFS (Phase III)
From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years. · months
| Arm I (PLD, Atezolizumab) | 4.0 months |
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| Arm II (PLD, Bevacizumab, Atezolizumab) | 7.4 months |
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| Arm III (PLD, Bevacizumab) | 5.6 months |
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