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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveal Melanoma | Device: Novocure Optune Drug: Opdivo Drug: Yervoy | Phase 1 |
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
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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 |
- 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.
- 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)
- 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.

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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 |
Inclusion Criteria:
- Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant 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 first administration of drug
- Sexually active and WOCBP, patient and partner must agree to use adequate contraception
- Normal organ and marrow function
- ECOG 0-1
- Life expectancy of 3 months or greater
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 C1D1 of study treatment
- 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)
- 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.)
- 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.
- Patient is unwilling or unable to comply with study procedures
- 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.

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
Contact: Justin Moser, MD | 480-323-1350 | jmoser@honorhealth.com |
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 |
Principal Investigator: | Justin Moser, MD | HonorHealth Research Institute |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
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 |