Using Tumor-Treating Fields with Immune Therapy for Metastatic Uveal Melanoma

Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

This study is testing whether using Tumor Treating Fields along with immune therapy can help people with advanced uveal melanoma, especially those with liver tumors, feel better and have more treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: HonorHealth Research Institute (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Scottsdale, Arizona and 1 other locations)
• Trial ID: NCT05004025 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Tumor Treating Fields (TTF) in combination with immune checkpoint inhibitors, nivolumab and ipilimumab, for patients with metastatic uveal melanoma, particularly those with liver metastases. Uveal melanoma is the most common eye cancer in adults, and this trial aims to improve outcomes for patients who have limited treatment options. The study will assess the safety and efficacy of TTF, which has previously been approved for other cancers, in activating immune responses against the tumor. Participants will receive TTF alongside standard immune therapy to evaluate potential improvements in treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic uveal melanoma primarily affecting the liver.

Not a fit: Patients with a history of severe immune-related adverse events from previous checkpoint inhibitor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of existing therapies for metastatic uveal melanoma.

How similar studies have performed: While Tumor Treating Fields have shown promise in other cancers, this specific combination approach in metastatic uveal melanoma is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
2. Age 18 years or older and willing and able to provide informed consent
3. WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
4. Sexually active and WOCBP, patient and partner must agree to use adequate contraception
5. Normal organ and marrow function
6. ECOG 0-1
7. Life expectancy of 3 months or greater

Exclusion Criteria:

1. History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
2. Prior treatment with anti cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) therapy within 90 days of C1D1 of study treatment
3. Prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of C1D1 of study treatment
4. AEs from prior anticancer therapies that have not resolved to grade 1 or less, other than endocrine related irAEs for which patients are on appropriate replacement therapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes)
5. History of or active autoimmune disease requiring systemic corticosteroid or immunosuppressive therapy. (Patients who have limited autoimmune disease not requiring systemic therapy or autoimmune disease that is unlikely to recur, such as ulcerative colitis s/p colectomy, will be allowed to enroll.)
6. Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
7. Patient is unwilling or unable to comply with study procedures
8. Patients with implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices; sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes typically used for TTFields studies.

Where this trial is running

Scottsdale, Arizona and 1 other locations

• HonorHealth Research Institute — Scottsdale, Arizona, United States (Recruiting)
• The Angeles Clinic and Research Insititute — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Justin Moser, MD — HonorHealth Research Institute
• Study coordinator: Justin Moser, MD

Conditions Uveal Melanoma