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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)

Secondary outcome measures

Incidence of Adverse Events

Overall Survival

Progression Free Survival (PFS)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,897 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,634 Previous Clinical Trials

4,126,841 Total Patients Enrolled

Marlana Orloff, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals involved in this clinical trial?

"This trial is not seeking participants at the present moment. It was first published on May 2nd 2018, and last amended on August 15th 20202. For those who are searching for clinical trials related to liver conditions, there are currently 3039 studies actively enrolling individuals; in addition, 765 research projects involving Embolization Therapy have open recruitment spots available."

Answered by AI

Are there any open enrollment slots for this trial currently available?

"Unfortunately, we are no longer recruiting participants for this study. It was initially advertised on May 2nd 2018 and its parameters were most recently revised on August 15th 2022. For those searching for alternative clinical trials, there are presently 3039 studies related to liver issues and 765 Embolization Therapy research projects actively seeking patients."

Answered by AI

To what extent has Embolization Therapy been tested in medical trials?

"Currently, the medical community is conducting 765 Embolization Therapy clinical trials. 86 of those studies have reached their third phase and are actively recruiting patients from 42707 sites across the globe, with a concentration in Pittsburgh, Pennsylvania."

Answered by AI

What health concerns can be addressed with Embolization Therapy?

"Embolization Therapy is a popular anti-angiogenic treatment, and has been used to effectively manage malignant neoplasms, unresectable melanoma, squamous cell carcinoma, as well other conditions."

Answered by AI

What would be the potential risks from Embolization Therapy for patients?

"Our judgement of embolization therapy's security is a 2 given that this Phase 2 trial has evidence suggesting safety but no corroborating data regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver

2018. "Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03472586.