Spots Global Cancer Trial Database for Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung

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Trial Identification

Brief Title: Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung

Official Title: Aerosolized Granulocyte-Macrophage Colony Stimulating Factor (Sargramostim) in Combination With Anti-PD1 Therapy for the Treatment of Metastatic Melanoma to the Lung

Study ID: NCT05717140

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8

Metastatic Malignant Neoplasm in the Lung

Metastatic Melanoma

Recurrent Melanoma

Unresectable Melanoma

Interventions

Aerosol Sargramostim

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Medical Device Usage and Evaluation

Nivolumab

Study Description

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVE: I. To determine feasibility, safety (maximum tolerated dose, MTD), and/or the maximally immunologically effective dose of aerosolized sargramostim (aSAR) administered as an inhalation in combination with nivolumab for the treatment of patients with metastatic malignant melanoma with evidence of pulmonary metastases. SECONDARY OBJECTIVES: I. To assess the pharmacodynamics of inhaled aSAR administered in combination with nivolumab for the treatment of metastatic malignant melanoma. II. To gather preliminary data on the clinical efficacy of aSAR + nivolumab therapy as 2nd line treatment for patients with metastatic melanoma. OUTLINE: This is a dose escalation study of aerosolized sargramostim. Patients receive aerosolized sargramostim via inhalation using the Aerogen Solo nebulization device and receive nivolumab intravenously (IV) on study. Patients also undergo collection of blood samples on study and undergo computed tomography (CT) or magnetic resonance imaging (MRI) at screening and on study.