Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Immunotherapy + Immunoembolization for Metastatic Uveal Melanoma
Phase 2
Waitlist Available
Led By Marlana Orloff, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
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 up to 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is studying a combination of immunotherapy drugs to treat patients with uveal melanoma that has spread to the liver.
Who is the study for?
This trial is for adults with uveal melanoma that has spread to the liver. Participants must be in good physical condition (ECOG 0 or 1), have certain normal blood and liver function tests, not be pregnant or breastfeeding, agree to use effective contraception, and have a measurable tumor in the liver.
What is being tested?
The study is testing if combining two immune-boosting drugs, Ipilimumab and Nivolumab, with a procedure called immunoembolization improves outcomes for patients. Immunoembolization aims to cut off blood supply to tumors while stimulating an immune response against cancer cells.
What are the potential side effects?
Ipilimumab and Nivolumab can cause side effects like fatigue, skin reactions, digestive issues, hormonal changes affecting glands such as thyroid; they may also lead to inflammation of organs like lungs or intestines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Secondary study objectives
Incidence of Adverse Events
Overall Survival
Progression Free Survival (PFS)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ipilimumab, nivolumab, immunoembolization)Experimental Treatment3 Interventions
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,831 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,574 Total Patients Enrolled
Marlana Orloff, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University