NCT05717140

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Malignant Neoplasm in the Lung
• Metastatic Melanoma
• Recurrent Melanoma
• Unresectable Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Aerosol Sargramostim	Given via inhalation with nebulizer
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Medical Device Usage and Evaluation	Use Aerogen Solo nebulization device
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2025-10-28
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2023-02-08
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study