Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
| Condition | Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7 |
|---|---|
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Status | Active, not recruiting |
| Enrollment | 245 participants |
| Interventions | Ipilimumab, Sargramostim |
| Start date | Dec 28, 2010 |
| Completion date | Feb 15, 2013 |
| Results posted | Apr 2, 2015 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
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- 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)
- Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, — National Cancer Institute (NCI)