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

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

Brief Summary

      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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Overall Response Rate

Secondary Outcome

 Overall Survival Rate

Condition

Uveal Melanoma

Intervention

Novocure Optune

Study Arms / Comparison Groups

 TTF Plus Chemotherapy

Description:  Novacure Optune with Opdivo and Yervoy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

10

Start Date

February 28, 2022

Completion Date

August 29, 2025

Primary Completion Date

August 2025

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.
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Justin Moser, MD, 480-323-1350, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT05004025

Organization ID

TTFields-UM

Responsible Party

Sponsor

Study Sponsor

HonorHealth Research Institute

Collaborators

 NovoCure Ltd.

Study Sponsor

Justin Moser, MD, Principal Investigator, HonorHealth Research Institute

Verification Date

March 2022