Stopped: Lack of funding
This phase II trial tests the safety, best dose, and effectiveness of inhaled aerosolized sargramostim in combination with standard immunotherapy (nivolumab) for the treatment of patients with melanoma that has spread from where it first started (primary site) to the lung (metastatic to the lung). Sargramostim works to stimulate the immune system by prompting the bone marrow to produce more white blood cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. In this study, an aerosolized form of sargramostim is inhaled using a device called a nebulizer, which can deliver the drug directly to the lungs. Inhalation of aerosolized sargramostim in combination with nivolumab may be more effective at treating patients melanoma metastatic to the lung.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Maximum tolerated dose (MTD)
Timeframe: During the first cycle of treatment (each Cycle = 28 ±3 days)
Incidence of adverse events
Timeframe: Up to 30 days after last treatment
Progression-free survival (PFS)
Timeframe: Time from study entry to the documentation of disease progression, assessed up to 2 years after registration
Overall survival (OS)
Timeframe: Time from study entry to death, assessed up to 2 years after registration