Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
| Заболевание | Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7 |
|---|---|
| Фаза | Фаза 2 |
| Спонсор | National Cancer Institute (NCI) |
| Статус | Идёт, набор закрыт |
| Участники | 245 участн. |
| Вмешательство | Ipilimumab, Sargramostim |
| Дата начала | 28.12.2010 |
| Дата завершения | 15.02.2013 |
| Публикация результатов | 2.04.2015 |
Кратко
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 |
Открыть в BENITIONS Открыть на ClinicalTrials.gov
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