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Checkpoint Inhibitor
Aerosolized Sargramostim + Immunotherapy for Melanoma
Phase 1
Waitlist Available
Led By Svetomir N. Markovic, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Confirmed diagnosis of unresectable stage IV metastatic melanoma involving the lungs (at least) that has progressed after at least ONE line of Food and Drug Administration (FDA) approved therapy (either immune checkpoint inhibitor or targeted therapy) OR relapse of melanoma following/during FDA-approved adjuvant or neo-adjuvant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study entry to the documentation of disease progression, assessed up to 2 years after registration
Awards & highlights
Study Summary
This trial tests a combination of immunotherapy and aerosolized sargramostim to see if it can help treat melanoma that has spread to the lungs.
Who is the study for?
Adults with stage IV melanoma in the lungs, who've had at least one prior treatment or relapse after adjuvant therapy. They must have good organ function, not be pregnant or nursing, agree to use contraception, and can't have severe diseases that would interfere with the trial.Check my eligibility
What is being tested?
The trial is testing aerosolized Sargramostim combined with Nivolumab immunotherapy for lung metastasized melanoma. It aims to find a safe dose and see if this combination helps the immune system fight cancer more effectively than standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to stimulating white blood cell production and typical immunotherapy issues like inflammation of organs, fatigue, digestive problems, skin reactions, and potential worsening of autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My melanoma cannot be surgically removed, has spread to my lungs, and has worsened after treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from study entry to the documentation of disease progression, assessed up to 2 years after registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study entry to the documentation of disease progression, assessed up to 2 years after registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (aerosolized sargramostim, nivolumab)Experimental Treatment6 Interventions
Patients receive aerosolized sargramostim via inhalation using the Aerogen Solo nebulization device and receive nivolumab IV on study. Patients also undergo collection of blood samples on study and undergo CT or MRI at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,060 Total Patients Enrolled
Svetomir N. Markovic, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
Svetomir N MarkovicPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
530 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your hemoglobin level is at least 8.0 grams per deciliter.I am on medication for an ongoing lung condition.I am 18 years old or older.I agree to use birth control during and for 6 months after treatment.Your kidney function, as measured by a blood test called serum creatinine, should be within a certain range.Your platelet count is at least 75,000 per cubic millimeter.My melanoma cannot be surgically removed, has spread to my lungs, and has worsened after treatment.Your oxygen levels are above 90% when measured at rest without using extra oxygen.I am immunocompromised or HIV positive and on antiretroviral therapy.Your liver enzymes (ALT and AST) are not more than 3 times the upper limit of normal, based on a test done within 15 days before joining the study.My cancer is a type of eye melanoma that has spread.I am fully active or restricted in physically strenuous activity but can do light work.Your kidneys are working well, as shown by a recent test using the Cockcroft-Gault formula.I don't have any serious ongoing illnesses or severe allergies to treatments.You have a detectable tumor according to specific guidelines.I have had a solid organ transplant.I am currently on medication for an autoimmune disease.Your white blood cell count is at least 1500 per cubic millimeter.I have cancer that has spread to the lining of my brain and spinal cord.I have untreated brain metastases.I have received a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (aerosolized sargramostim, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted clearance for aerosolized sargramostim and nivolumab as a therapeutic treatment?
"Considering the phase 2 status of this therapy, which implies a lack of clinical data supporting efficacy but some pointing to safety, our team has rated the treatment (aerosolized sargramostim and nivolumab) as having a score of two."
Answered by AI
Is this experiment in search of new participants?
"Unfortunately, according to clinicaltrials.gov the trial associated with this study is not currently accepting participants. The listing for this research was initially published on February 3rd of 2023 and has been edited as recently as January 30th. Nonetheless, there are still over 3000 other trials actively recruiting patients at present."
Answered by AI
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