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

Uveal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004025
• Other study ID #: TTFields-UM
• Status: Recruiting
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: August 29, 2025

Study information

• Verified date: June 2024
• Source: HonorHealth Research Institute
• Contact: Justin Moser, MD
• Phone: 480-323-1350
• Email: jmoser[@]honorhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 29, 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Device:
• Novocure Optune
Novacure Optune with Opdivo and Yervoy

Drug:
• Opdivo
Novacure Optune with Opdivo and Yervoy
• Yervoy
Novacure Optune with Opdivo and Yervoy

Locations

Country	Name	City	State
United States	The Angeles Clinic and Research Insititute	Los Angeles	California
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
HonorHealth Research Institute	NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.	from the initiation of study treatment and through study completion, up to 1 year
Primary	Overall Safety	Evaluate the safety of TTF in combination with nivolumab and ipilimumab (Number of patients who developed grade 3 treatment-related adverse events as assessed by CTCAE v5)	From the initiation of study treatment and through study completion, up to 1 year
Secondary	Overall Survival Rate	to assess the median progression free survival and overall survival of treated patients.	From initiation of study treatment until date of death from any cause, up to 100 months