Clinical Trials /

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

NCT05004025

Description:

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

Related Conditions:
  • Uveal Melanoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
  • Official Title: Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

Clinical Trial IDs

  • ORG STUDY ID: TTFields-UM
  • NCT ID: NCT05004025

Conditions

  • Uveal Melanoma

Interventions

DrugSynonymsArms
OpdivoTTF Plus Chemotherapy
YervoyTTF Plus Chemotherapy

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TTF Plus ChemotherapyExperimentalNovacure Optune with Opdivo and Yervoy
  • Opdivo
  • Yervoy

Eligibility Criteria

        Inclusion Criteria:

          1. Patient has histologically or cytologically confirmed metastatic uveal melanoma with
             predominant 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 first
             administration of drug

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

          5. Normal organ and marrow function

          6. ECOG 0-1

          7. Life expectancy of 3 months or greater

        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 C1D1 of
             study treatment

          4. 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)

          5. 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.)

          6. 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.

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

          8. 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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:from the initiation of study treatment and through study completion, up to 1 year
Safety Issue:
Description:evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.

Secondary Outcome Measures

Measure:Overall Survival Rate
Time Frame:From initiation of study treatment until date of death from any cause, up to 100 months
Safety Issue:
Description:to assess the median progression free survival and overall survival of treated patients.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:HonorHealth Research Institute

Last Updated

August 13, 2021