NCT03149159撤回2 期
An Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients with a partial or complete response
研究概览
简要总结
The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.
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
- •Histologically or cytologically confirmed diagnosis of metastatic ccRCC.
- •Age 18 years and older
- •Progressive disease after treatment with single-agent nivolumab
- •Life expectancy at least 3 months
- •Presence of measurable disease per RECIST 1.1 criteria
- •Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment
- •Adequate organ system function
- •WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.
排除标准
- •Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol).
- •Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs.
- •Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- •Presence of a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- •Note: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Unstable angina or uncontrolled congestive heart failure
- •Uncontrolled hypercalcemia
- •Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Presence of other malignant diseases, except non-melanoma skin care
- •History of allergy to study drug components.
- •History of severe hypersensitivity reaction to any monoclonal antibody.
- •Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration.
- •Women must not be pregnant or breastfeeding. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
- •Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated
研究组 & 干预措施
Nivolumab + Ipilimumab + SRT
Experimental
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab + SRT
Experimental
干预措施: Ipilimumab (Drug)
Nivolumab + Ipilimumab + SRT
Experimental
干预措施: Steriotactic radiation therapy (Radiation)
结局指标
主要结局
Number of patients with a partial or complete response
时间窗: 12 weeks
The response rate of combined ipilimumab and nivolumab plus STR will be determined using irRECIST criteria.
次要结局
- Progression free survival (PFS)(2 years)
研究者
研究点 (1)
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