Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Фаза 2
Завершено
NCT01708941
| Заболевание | Recurrent Melanoma, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7 |
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| Фаза | Фаза 2 |
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| Спонсор | National Cancer Institute (NCI) |
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| Статус | Завершено |
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| Участники | 88 участн. |
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| Вмешательство | Ipilimumab, Laboratory Biomarker Analysis, Recombinant Interferon Alfa-2b |
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| Дата начала | 25.03.2013 |
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| Дата завершения | 8.08.2017 |
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| Публикация результатов | 11.01.2019 |
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Кратко
This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.
Progression-free Survival (PFS)
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years · months
| Ipilimumab + HDI | 7.5 months |
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| Ipilimumab Alone | 4.4 months |
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