Immunotherapy + Immunoembolization for Metastatic Uveal Melanoma

Overseen By Marlana Orloff, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Must not be taking: Immunosuppressants

Disqualifiers: Brain metastases, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.

Research Team

Marlana Orloff, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

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.

Inclusion Criteria

You have advanced uveal melanoma that has spread to the liver, and at least one of the liver tumors is at least 10 millimeters in size.

Your AST and ALT levels are within three times the normal range.

Your white blood cell count is at least 1000 per cubic millimeter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ipilimumab and nivolumab IV and undergo immunoembolization. Cycles repeat every 3 weeks for 12 weeks.

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 1 year

Treatment Details

Interventions

• Embolization Therapy
• Ipilimumab
• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Treatment (ipilimumab, nivolumab, immunoembolization) Experimental Treatment 3 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.

Ipilimumab is already approved in United States, European Union for the following indications:

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania