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Trial record 1 of 1 for:    05004025
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Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

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ClinicalTrials.gov Identifier: NCT05004025
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : April 1, 2022
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
HonorHealth Research Institute

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Tumor-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 : February 28, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 29, 2025


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 Name: Nivolumab

Drug: Yervoy
Novacure Optune with Opdivo and Yervoy
Other Name: Ipilimumab




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05004025


Contacts
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Contact: Justin Moser, MD 480-323-1350 jmoser@honorhealth.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN, AOCNS    480-323-1364    clinicaltrials@honorhealth.com   
Contact: Andrea House    480-323-1364    clinicaltrials@honorhealth.com   
Principal Investigator: Justin Moser, MD         
Sponsors and Collaborators
HonorHealth Research Institute
NovoCure Ltd.
Investigators
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Principal Investigator: Justin Moser, MD HonorHealth Research Institute
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT05004025    
Other Study ID Numbers: TTFields-UM
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action