Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
| 대상 질환 | Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7 |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | National Cancer Institute (NCI) |
| 상태 | 진행 중(모집 완료) |
| 참여자 수 | 245 명 |
| 중재(약물) | Ipilimumab, Sargramostim |
| 시작일 | 2010년 12월 28일 |
| 완료일 | 2013년 2월 15일 |
| 결과 공개일 | 2015년 4월 2일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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