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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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

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