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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05004025
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	HonorHealth Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Justin Moser, MD
Principal Investigator Affiliation	HonorHealth Research Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: TTF Plus Chemotherapy

Novacure Optune with Opdivo and Yervoy

Interventions

Device: - Novocure Optune

Novacure Optune with Opdivo and Yervoy

Drug: - Opdivo

Novacure Optune with Opdivo and Yervoy

Drug: - Yervoy

Novacure Optune with Opdivo and Yervoy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Research Institute, Scottsdale, Arizona

Status

Recruiting

Address

HonorHealth Research Institute

Scottsdale, Arizona, 85258

Site Contact

Clinical Trials Nurse Navigator

[email protected]

833-354-6667

Los Angeles, California

Status