Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
| 适应症 | Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7 |
|---|---|
| 分期 | 2期 |
| 申办方 | National Cancer Institute (NCI) |
| 状态 | 进行中（已停止招募） |
| 受试者人数 | 245 人 |
| 干预（药物） | Ipilimumab, Sargramostim |
| 开始日期 | 2010年12月28日 |
| 完成日期 | 2013年2月15日 |
| 结果公布日 | 2015年4月2日 |
摘要
This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.
Overall Survival
| Arm A (Ipilimumab and Sargramostim) | 17.5 Months |
|---|---|
| Arm B (Ipilimumab) | 12.7 Months |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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- A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration — National Cancer Institute (NCI)
- Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-I — National Cancer Institute (NCI)
- Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab — National Cancer Institute (NCI)
- Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With — Bristol-Myers Squibb
- Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Select — National Cancer Institute (NCI)
- Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, — National Cancer Institute (NCI)