NCT06053658
招募中
2 期
Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
概览
简要总结
To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
详细描述
Primary Objectives
- To demonstrate efficacy of combination tivozanib and nivolumab in advanced non-clear cell renal cell carcinoma (nccRCC).
Secondary Objectives
- To assess the safety and toxicity of combination tivozanib and nivolumab.
- To estimate the duration of clinical efficacy
Exploratory Objectives
- To associate immune and tumor biomarkers with clinical efficacy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or not otherwise specified (NOS) as clear cell. Medullary carcinoma of the kidney and collecting duct tumors are NOT allowed
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Up to 1 systemic line of therapy (either monotherapy or combination) including prior immunotherapy (anti-PD1, PD-L1, or CTLA-4) and multi-tyrosine kinase inhibitors in non-metastatic or metastatic setting is allowed. A washout period of 5 half lives or 21 days, whichever one is shorter, will be required for patients that have received previous systemic therapy.
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) Appendix 1 performance status ≤2 (Karnofsky ≥60%).
- •Patients must have adequate organ and marrow function as defined below:
- •absolute neutrophil count ≥1,000/mcL
- •platelets ≥100,000/mcL
- •total bilirubin ≤ institutional upper limit of normal (ULN)
- •AST ≤3 × institutional ULN
排除标准
- •Prior tivozanib therapy.
- •Prior nivolumab therapy.
- •Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
- •Patients who are receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or nivolumab.
- •Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 2 hours apart. Anti-hypertensives must not have been increased 30 days prior to enrollment.
- •History of autoimmune disorders except for the following:
- •Patients with vitiligo or alopecia
- •Hypothyroidism (e.g. following Hashimoto syndrome) that is stable on thyroid hormone replacement
- •Any chronic skin condition that does not require systemic therapy
研究组 & 干预措施
Combination Tivozanib and Nivolumab
Experimental
Nivolumab by vein over about 60 minutes every 4 weeks (Day 1 of each cycle). Tivozanib tablets by mouth 1 time every day for 21 days (Days 1-21 of each cycle), and then no tablets on Days 22-28 of each cycle.
干预措施: Tivozanib (Drug)
Combination Tivozanib and Nivolumab
Experimental
Nivolumab by vein over about 60 minutes every 4 weeks (Day 1 of each cycle). Tivozanib tablets by mouth 1 time every day for 21 days (Days 1-21 of each cycle), and then no tablets on Days 22-28 of each cycle.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; average of 1 year
次要结局
未报告次要终点
研究者
研究点 (5)
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