Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
第3相
実施中（募集終了）
NCT02224781
| 対象疾患 | Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma |
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| 相 | 第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 | 267 名 |
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| 介入（薬剤） | Biospecimen Collection, Computed Tomography, Dabrafenib Mesylate, Echocardiography Test, Ipilimumab |
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| 開始日 | 2015年9月8日 |
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| 完了日 | 2023年9月30日 |
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| 結果公開日 | 2026年2月18日 |
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概要
This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
2-year Overall Survival (OS)
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry · Proportion of participants
| Arm A (Immunotherapy) | 0.683 Proportion of participants |
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| Arm B (BRAF Inhibitor Therapy) | 0.541 Proportion of participants |
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