NCT05004025

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.

Detailed description

Uveal melanoma is the most common ocular malignancy for adults and despite effective therapies, roughly 50% of patients will develop metastatic disease. Currently there is no therapy to improve the prognosis of patients with metastatic disease and these patients are usually treated with regimens used for cutaneous melanoma. Tumor Treating Fields is a new type of anti-cancer therapy approved by the FDA for use in glioblastoma multiforme and mesothelioma. TTF has been shown to activate the STING pathway leading to increased levels of dendritic cells in regional lymph nodes.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DEVICE	Novocure Optune	Novacure Optune with Opdivo and Yervoy
DRUG	Opdivo	Novacure Optune with Opdivo and Yervoy
DRUG	Yervoy	Novacure Optune with Opdivo and Yervoy

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-11-18
• Completion: 2025-07-23
• First posted: 2021-08-13
• Last updated: 2025-08-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study