Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
Who is this study for? Patients with metastatic uveal melanoma
What treatments are being studied? Novocure Optune+Opdivo+Yervoy
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
• Age 18 years or older and willing and able to provide informed consent
• WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
• Sexually active and WOCBP, patient and partner must agree to use adequate contraception
• Normal organ and marrow function
• ECOG 0-1
• Life expectancy of 3 months or greater
Locations
United States
Arizona
HonorHealth Research Institute
Scottsdale
California
The Angeles Clinic and Research Insititute
Los Angeles
Time Frame
Start Date: 2022-02-28
Completion Date: 2025-07-23
Participants
Target number of participants: 10
Treatments
Experimental: TTF Plus Chemotherapy
Novacure Optune with Opdivo and Yervoy
Authors
Related Therapeutic Areas
Sponsors
Collaborators: NovoCure Ltd.
Leads: HonorHealth Research Institute