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 Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
October 2021
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
, 480-323-1350, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05004025
Organization ID
TTFields-UM
Responsible Party
Sponsor
Study Sponsor
HonorHealth Research Institute
Collaborators
NovoCure Ltd.
Study Sponsor
, ,
Verification Date
September 2021