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
| 対象疾患 | Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma |
|---|---|
| 相 | 第3相 |
| スポンサー | National Cancer Institute (NCI) |
| ステータス | 実施中（募集終了） |
| 参加者数 | 1,301 名 |
| 介入（薬剤） | Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Pembrolizumab |
| 開始日 | 2015年11月10日 |
| 完了日 | 2023年9月15日 |
| 結果公開日 | 2024年8月27日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
- 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)