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Checkpoint Inhibitor
ipilimumab for Uveal Melanoma
Phase 1 & 2
Waitlist Available
Research Sponsored by David Minor, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5years
Awards & highlights
Summary
This trial is testing whether combining immunotherapy with radiation therapy is more effective than immunotherapy alone for treating uveal melanoma that has spread to the liver.
Eligible Conditions
- Uveal Melanoma
- Liver Metastases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
safety and tolerability of sequential selective internal radiation with Yttrium90 followed by immunotherapy with ipilimumab and nivolumab.
Secondary study objectives
Correlation of tissue markers and response to immunotherapy
Immunotherapy
Preliminary clinical efficacy
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: hepatic radiation followed by immunotherapyExperimental Treatment3 Interventions
SIR-Spheres Yttrium 90 will be given by injection into the hepatic artery in two treatments, one for each lobe. 3-5 weeks later patients receive concurrent ipilimumab 1mg/kg q 3 wk x 4 and nivolumab 3mg/kg q 3 weeks x 4, all followed by nivolumab 240mg/kg q 2 weeks or 480 mg q 4 weeks until progression or 3 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
David Minor, MDLead Sponsor
Jefferson Medical College of Thomas Jefferson UniversityOTHER
12 Previous Clinical Trials
13,844 Total Patients Enrolled
University of ChicagoOTHER
1,034 Previous Clinical Trials
753,668 Total Patients Enrolled
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