Immunotherapy + Immunoembolization for Metastatic Uveal Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment for uveal melanoma, a type of eye cancer that has spread to the liver. It combines the immunotherapy drugs ipilimumab (Yervoy) and nivolumab (Opdivo), which help the immune system attack the cancer, with a procedure called immunoembolization. This procedure cuts off the blood supply to the tumors while boosting the immune response. Individuals with uveal melanoma that has spread to the liver and covers less than half of it might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that immunosuppressive treatments should not be taken within 4 weeks before starting the trial, unless it's a low dose of prednisone (5 mg or less). It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of two drugs, ipilimumab and nivolumab, has been tested in patients with various types of melanoma, including those that spread to the liver. This drug combo helps the immune system fight cancer but can also cause serious side effects, such as lung infections, fever, diarrhea, and breathing problems.
Previous studies have explored using these drugs with a procedure called immunoembolization, which blocks blood flow to the tumor and may enhance the immune response. This procedure has been found to be safe, but side effects can still occur.
This trial is in its second phase, indicating that the treatment has shown some safety in earlier tests, but researchers continue to monitor for any side effects. Prospective participants should discuss the potential risks and benefits with a healthcare provider before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of ipilimumab, nivolumab, and immunoembolization for metastatic uveal melanoma because it offers a unique approach by integrating immunotherapy with a targeted procedure. Unlike standard treatments like surgery or radiation, this combination leverages the body's immune system through ipilimumab and nivolumab, which are immune checkpoint inhibitors that help the immune system recognize and attack cancer cells more effectively. Additionally, immunoembolization directly delivers therapy to the liver, where uveal melanoma often spreads, which could enhance the overall effectiveness of treatment. This strategy may provide a more powerful and targeted attack on the cancer, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for metastatic uveal melanoma?
In this trial, participants will receive a combination of ipilimumab and nivolumab. Research has shown that these drugs can help people with melanoma live longer, even in advanced cases. They work by enabling the immune system to attack cancer cells. Additionally, participants will undergo immunoembolization, a treatment previously used for metastatic uveal melanoma, which is melanoma that has spread to the liver. Immunoembolization cuts off the blood supply to the tumor, potentially killing cancer cells and boosting the immune response. Although still under study, early results suggest it could be effective for uveal melanoma that has spread to the liver.24567
Who Is on the Research Team?
Marlana Orloff, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ipilimumab and nivolumab IV and undergo immunoembolization. Cycles repeat every 3 weeks for 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
Citations
Nivolumab and Ipilimumab in the Treatment of Metastatic ...
The combination of nivolumab and ipilimumab has shown a survival benefit in patients with cutaneous melanoma at the expense of immune-related ...
THOMAS JEFFERSON UNIVERSITY
Combination treatment with ipilimumab and immunoembolization in metastatic uveal melanoma, a feasibility study. J Clin Oncol 33, 2015 (suppl; abstr e20015).
067 Which Showed Continued Durable Long-Term ...
These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial; data selected for official ESMO ...
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Efficacy in ...
Find efficacy information for OPDIVO® (nivolumab) + YERVOY® (ipilimumab) in metastatic melanoma. Please see Indications and Important Safety Information.
How we treat patients with metastatic uveal melanoma
Tebentafusp became the first-in-class ImmTAC to improve overall survival in metastatic uveal melanoma patients.
Safety and Efficacy of Ipilimumab plus Nivolumab and ...
Despite recent progress on the treatment of metastatic uveal melanoma (mUM), prognosis remains dismal for the majority of patients.
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Safety in ...
The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.