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

Last updated: June 14, 2024
Sponsor: HonorHealth Research Institute
Overall Status: Active - Recruiting

Phase

1

Condition

Melanoma

Treatment

Opdivo

Novocure Optune

Yervoy

Clinical Study ID

NCT05004025
TTFields-UM
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has histologically or cytologically confirmed metastatic uveal melanoma withpredominant 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 firstadministration of drug

  4. Sexually active and WOCBP, patient and partner must agree to use adequatecontraception

  5. Normal organ and marrow function

  6. ECOG 0-1

  7. Life expectancy of 3 months or greater

Exclusion

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 C1D1of study treatment

  4. AEs from prior anticancer therapies that have not resolved to grade 1 or less, otherthan endocrine related irAEs for which patients are on appropriate replacementtherapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes)

  5. History of or active autoimmune disease requiring systemic corticosteroid orimmunosuppressive therapy. (Patients who have limited autoimmune disease notrequiring systemic therapy or autoimmune disease that is unlikely to recur, such asulcerative colitis s/p colectomy, will be allowed to enroll.)

  6. Serious medical risk factors involving any of the major organ systems such that theInvestigator considers it unsafe for the patient to receive an experimental researchdrug.

  7. Patient is unwilling or unable to comply with study procedures

  8. Patients with implanted pacemaker, defibrillator, nerve stimulator or other activeelectronic medical devices; sensitive to conductive hydrogels used onelectrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes typically used for TTFields studies.

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: Opdivo
Phase: 1
Study Start date:
February 28, 2022
Estimated Completion Date:
August 29, 2025

Study 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.

Connect with a study center

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • The Angeles Clinic and Research Insititute

    Los Angeles, California 90025
    United States

    Active - Recruiting

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