Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
| 适应症 | Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma |
|---|---|
| 分期 | 3期 |
| 申办方 | National Cancer Institute (NCI) |
| 状态 | 进行中（已停止招募） |
| 受试者人数 | 1,301 人 |
| 干预（药物） | Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Pembrolizumab |
| 开始日期 | 2015年11月10日 |
| 完成日期 | 2023年9月15日 |
| 结果公布日 | 2024年8月27日 |
摘要
This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.
Overall Survival (OS)
| FDA Approved Regimen (SOC) | 76 percentage of participants |
|---|---|
| MK-3475 (Pembrolizumab) | 82 percentage of participants |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- 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)
- Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Me — National Cancer Institute (NCI)