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
| 대상 질환 | Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | National Cancer Institute (NCI) |
| 상태 | 진행 중(모집 완료) |
| 참여자 수 | 1,301 명 |
| 중재(약물) | Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Pembrolizumab |
| 시작일 | 2015년 11월 10일 |
| 완료일 | 2023년 9월 15일 |
| 결과 공개일 | 2024년 8월 27일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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