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

NCT05717140 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Svetomir N. Markovic, M.D., Ph.D. · Mayo Clinic in Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-01-28
Completion
2026-01-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717140 on ClinicalTrials.gov