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

NCT05004025 | Completed Phase 1 FDA Device

• 1 other identifier: TTFields-UM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.

  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)

  From the initiation of study treatment and through study completion, up to 1 year

Secondary Outcomes (1)

• Overall Survival Rate

  From initiation of study treatment until date of death from any cause, up to 100 months

Study Arms (1)

TTF Plus Chemotherapy

EXPERIMENTAL

Novacure Optune with Opdivo and Yervoy

Device: Novocure Optune; Drug: Opdivo; Drug: Yervoy

Interventions

Novocure Optune DEVICE

Novacure Optune with Opdivo and Yervoy

TTF Plus Chemotherapy

Opdivo DRUG

Novacure Optune with Opdivo and Yervoy

Also known as: Nivolumab

TTF Plus Chemotherapy

Yervoy DRUG

Novacure Optune with Opdivo and Yervoy

Also known as: Ipilimumab

TTF Plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
• Prior treatment with anti cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) therapy within 90 days of C1D1 of study treatment
• Prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of C1D1 of study treatment
• 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)
• 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.)
• 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.
• Patient is unwilling or unable to comply with study procedures
• 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.

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• NovoCure Ltd.: collaborator

Study Sites (2)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

The Angeles Clinic and Research Insititute

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Justin Moser, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Tumor-Treating Fields in Combination with Immunotherapy

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 13, 2021
• Study Start: February 28, 2022
• Primary Completion: November 18, 2024
• Study Completion: July 23, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)