Uveal MelanomaPhase 1NCT05004025
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
A Phase 1 study testing Novocure Optune, Opdivo and Yervoy in people with Uveal Melanoma, run by HonorHealth Research Institute at 2 sites in United States.
Trial summary
Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Novocure Optune, Opdivo and Yervoy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2022to 23 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Angeles Clinic and Research Insititute
Los Angeles, California, 90025
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
Read the 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.
- Conditions
- Uveal Melanoma
- Being tested
- Novocure Optune, Opdivo, Yervoy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novocure OptuneDevice
Novacure Optune with Opdivo and Yervoy
OpdivoDrug
Also called Nivolumab
Novacure Optune with Opdivo and Yervoy
YervoyDrug
Also called Ipilimumab
Novacure Optune with Opdivo and Yervoy
| Study group | Role | What they receive |
|---|---|---|
| TTF Plus Chemotherapy | Experimental | Novacure Optune with Opdivo and Yervoy Receives: Device: Novocure Optune; Drug: Opdivo; Drug: Yervoy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.
Measured: from the initiation of study treatment and through study completion, up to 1 year
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)
Measured: From the initiation of study treatment and through study completion, up to 1 year
Secondary outcomes (1)
Overall Survival Rate
to assess the median progression free survival and overall survival of treated patients.
Measured: From initiation of study treatment until date of death from any cause, up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start28 Feb 2022
- Primary completion18 Nov 2024
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tumor-Treating Fields in Combination with Immunotherapy
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Justin Moser, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004025
- Sponsor's protocol ID
- TTFields-UM
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2021
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT05004025
- Acronym / sponsor ID
- TTFields-UM
- Conditions
- Uveal Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tumor-Treating Fields in Combination with Immunotherapy
| Arm | Type | Receives |
|---|---|---|
| TTF Plus Chemotherapy | Experimental | Device: Novocure Optune, Drug: Opdivo, Drug: YervoyNovacure Optune with Opdivo and Yervoy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novocure OptuneNovacure Optune with Opdivo and Yervoy | Device | TTF Plus Chemotherapy |
| OpdivoAlso: NivolumabNovacure Optune with Opdivo and Yervoy | Drug | TTF Plus Chemotherapy |
| YervoyAlso: IpilimumabNovacure Optune with Opdivo and Yervoy | Drug | TTF Plus Chemotherapy |
Primary outcome
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)
1 secondary outcome
Overall Survival Rate
Time frame: From initiation of study treatment until date of death from any cause, up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Moser, MD principal investigator
HonorHealth Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Novocure Optune, Opdivo and Yervoy in people with Uveal Melanoma, run by HonorHealth Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: from the initiation of study treatment and through study completion, up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.