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

• Sponsor: HonorHealth Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05004025
• Collaborator: NovoCure Ltd. (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Device: Novocure Optune; Drug: Opdivo; Drug: Yervoy	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Tumor-Treating Fields in Combination with ImmunotherapyTumor-Treating Fields in Combination with Immunotherapy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Aug 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TTF Plus Chemotherapy Novacure Optune with Opdivo and Yervoy	Device: Novocure Optune; Novacure Optune with Opdivo and Yervoy; Drug: Opdivo; Novacure Optune with Opdivo and Yervoy; Other Names: Nivolumab ; Drug: Yervoy; Novacure Optune with Opdivo and Yervoy; Other Names: Ipilimumab

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [from the initiation of study treatment and through study completion, up to 1 year]

   evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.

2. Overall Safety [From the initiation of study treatment and through study completion, up to 1 year]

   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)

Secondary Outcome Measures

1. Overall Survival Rate [From initiation of study treatment until date of death from any cause, up to 100 months]

   to assess the median progression free survival and overall survival of treated patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Scottsdale	Arizona	United States	85258

Sponsors and Collaborators

• HonorHealth Research Institute
• NovoCure Ltd.

Investigators

• Principal Investigator: Justin Moser, MD, HonorHealth Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HonorHealth Research Institute
• ClinicalTrials.gov Identifier: NCT05004025
• Other Study ID Numbers: TTFields-UM
• First Posted: Aug 13, 2021
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Melanoma; Uveal Neoplasms; Nivolumab; Ipilimumab

Study Results

No Results Posted as of Apr 1, 2022