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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
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Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTF Plus Chemotherapy | Experimental | Novacure Optune with Opdivo and Yervoy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novocure Optune | Device | Novacure Optune with Opdivo and Yervoy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Moser, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| The Angeles Clinic and Research Insititute |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Tumor-Treating Fields in Combination with Immunotherapy
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| Opdivo |
| Drug |
Novacure Optune with Opdivo and Yervoy |
|
|
| Yervoy | Drug | Novacure Optune with Opdivo and Yervoy |
|
|
| Los Angeles |
| California |
| 90025 |
| United States |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |