What side effects are associated with this type of intervention?

Common treatments for uveal melanoma include immune checkpoint inhibitors such as nivolumab and ipilimumab. These treatments can lead to side effects like fatigue, skin rash, diarrhea, and immune-related adverse events affecting organs such as the liver, lungs, and endocrine glands. Tumor Treating Fields (TTFields), which disrupt cell division using electric fields, are being studied in combination with these inhibitors. TTFields are generally well-tolerated but can cause skin irritation at the application site. The combination aims to enhance treatment efficacy while managing the side effect profile.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for uveal melanoma that utilize Tumor Treating Fields (TTFields). TTFields are a novel treatment modality that disrupts cancer cell division using electric fields and are currently being studied in combination with immune checkpoint inhibitors for metastatic uveal melanoma. Broadly, treatments for uveal melanoma include surgical resection, radiation therapy (such as proton beam therapy and plaque brachytherapy), and systemic therapies like immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and targeted therapies (e.g., vemurafenib for BRAF-mutant melanoma).

What other types of research exist?

Promising novel alternatives for Uveal Melanoma treatment in 2024 include immune checkpoint inhibitors such as nivolumab and ipilimumab, which have shown potential in combination with other therapies. Additionally, targeted therapies like BRAF inhibitors (e.g., trametinib) and MEK inhibitors (e.g., selumetinib) have demonstrated efficacy in treating melanoma with specific genetic mutations. These treatments offer new avenues for managing Uveal Melanoma beyond traditional methods.

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Checkpoint Inhibitor

Tumor-Treating Fields + Immunotherapy for Uveal Melanoma

Phase 1

Recruiting

Led By Justin Moser, MD

Research Sponsored by HonorHealth Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement

Normal organ and marrow function

Must not have

History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy

Patient is unwilling or unable to comply with study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initiation of study treatment and through study completion, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses electric fields to stop cancer cell growth. It targets patients with metastatic uveal melanoma, who often do not respond well to current treatments. The treatment works by boosting the immune system to help fight the cancer.

Who is the study for?

This trial is for adults with metastatic uveal melanoma, mainly affecting the liver. Participants must be in good physical condition (ECOG 0-1), have a life expectancy of at least 3 months, and normal organ/marrow function. Women of childbearing potential must test negative for pregnancy and use contraception. Excluded are those with active autoimmune diseases requiring strong medication, recent cancer treatments, or severe reactions to immune checkpoint inhibitors.

What is being tested?

The study tests Tumor-Treating Fields targeting liver metastases combined with Nivolumab and Ipilimumab—two immunotherapy drugs—in patients with metastatic uveal melanoma. The goal is to see if this combination improves patient outcomes compared to current treatments.

What are the potential side effects?

Possible side effects include skin irritation from the device used for Tumor-Treating Fields, as well as typical immune therapy-related issues like inflammation in organs, fatigue, digestive problems, skin reactions and potential worsening of autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of eye melanoma that has spread mainly to my liver.

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My organs and bone marrow are functioning normally.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe reaction to previous immunotherapy.

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I am willing and able to follow the study's procedures.

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I haven't had any cancer treatments in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of study treatment and through study completion, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of study treatment and through study completion, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of study treatment and through study completion, 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

Overall Response Rate

Overall Safety

Secondary study objectives

Overall Survival Rate

Awards & Highlights

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: TTF Plus ChemotherapyExperimental Treatment3 Interventions

Novacure Optune with Opdivo and Yervoy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Yervoy

2012

Completed Phase 2

~700

Opdivo

2017

Completed Phase 2

~110

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Uveal Melanoma include Tumor Treating Fields (TTFields), immune checkpoint inhibitors, and local therapies like radiation. TTFields work by disrupting cell division through electric fields, which can inhibit tumor growth and potentially improve outcomes. Immune checkpoint inhibitors, such as nivolumab and ipilimumab, enhance the body's immune response against cancer cells. Local therapies, including radiation (e.g., proton therapy and plaque brachytherapy), target the tumor directly while sparing surrounding tissues. These treatments are crucial for Uveal Melanoma patients as they offer targeted approaches to control tumor growth, improve survival rates, and maintain quality of life.

[Antitumor electro-chemotherapy].