Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Overall Response Rate
研究概览
简要总结
Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Life expectancy of 3 months or greater
排除标准
- •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.
研究组 & 干预措施
TTF Plus Chemotherapy
Novacure Optune with Opdivo and Yervoy
干预措施: Novocure Optune (Device)
TTF Plus Chemotherapy
Novacure Optune with Opdivo and Yervoy
干预措施: Opdivo (Drug)
TTF Plus Chemotherapy
Novacure Optune with Opdivo and Yervoy
干预措施: Yervoy (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 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
时间窗: 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)
次要结局
- Overall Survival Rate(From initiation of study treatment until date of death from any cause, up to 100 months)