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About
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.
Full 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.
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Inclusion criteria
Exclusion criteria
Active pulmonary disease requiring ongoing medication
Metastatic uveal melanoma
Any of the following because this study involves an investigational agent the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
Active central nervous system (CNS) metastases not previously treated
Any of the following prior therapies:
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
Active autoimmune disease requiring current systemic treatment with immunosuppressive or immune modulatory agents
NOTE: Exceptions are allowed for the following conditions:
Known uncontrolled intercurrent illness including, but not limited to:
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
History of severe hypersensitivity reactions to sargramostim or monoclonal antibodies
Prior history of grade 4 immune related adverse event (irAE) with prior immune checkpoint inhibitor (ICI) therapy or failure to recover (< grade 1) from immune-related adverse event(s) from prior ICI therapy
Failure to recover from adverse events related to any of the following therapies prior to registration:
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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