Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Novacure Optune with Opdivo and Yervoy
Novacure Optune with Opdivo and Yervoy
Novacure Optune with Opdivo and Yervoy
HonorHealth Research Institute
Scottsdale, Arizona, United States
The Angeles Clinic and Research Insititute
Los Angeles, California, United States
Overall Response Rate
evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.
Time frame: from the initiation of study treatment and through study completion, up to 1 year
Overall Safety
Evaluate the safety of TTF in combination with nivolumab and ipilimumab (Number of patients who developed grade 3 treatment-related adverse events as assessed by CTCAE v5)
Time frame: From the initiation of study treatment and through study completion, up to 1 year
Overall Survival Rate
to assess the median progression free survival and overall survival of treated patients.
Time frame: From initiation of study treatment until date of death from any cause, up to 100 months
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