Phase
Condition
Melanoma
Treatment
Opdivo
Novocure Optune
Yervoy
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has histologically or cytologically confirmed metastatic uveal melanoma withpredominant 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 firstadministration of drug
Sexually active and WOCBP, patient and partner must agree to use adequatecontraception
Normal organ and marrow function
ECOG 0-1
Life expectancy of 3 months or greater
Exclusion
Exclusion Criteria:
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 C1D1of study treatment
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)
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.)
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.
Patient is unwilling or unable to comply with study procedures
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
Study Description
Connect with a study center
HonorHealth Research Institute
Scottsdale, Arizona 85258
United StatesActive - Recruiting
The Angeles Clinic and Research Insititute
Los Angeles, California 90025
United StatesActive - Recruiting
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