A Phase 2 Pilot Study of the Efficacy and Safety of Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Complete Response Rate
研究概览
简要总结
The aim of this Phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-PD-1 antibody, and ipilimumab, an anti-CTLA-4 antibody, in T1aN0M0 clear-cell RCC patients ineligible for surgical treatment.
详细描述
Surgery remains the standard curative-intent therapy for localized renal cell carcinoma (RCC). Thus, systemic therapy for RCC should still be considered only in patients who have contraindications to surgery.
Results of Phase 3 CheckMate 214 study showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic RCC patients with a complete response rate of 11% (Motzer et al. Lancet Oncology 2019). Median time to objective response was 2.8 months. Among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan, whereas most converted from the partial response at a median of 6.9 months or from the stable disease at a median of 11.3 months.
We hypothesize that this combination could completely eliminate primary tumors in patients with small primary (less than 4 cm) ineligible for surgical treatment. There are no studies evaluating checkpoint inhibitors in this setting in RCC patients.
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
- •Cytologically proven clear-cell RCC
- •CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)
- •Inability to perform surgery for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason
- •No contradictions to nivolumab and ipilimumab
- •Age 18 or older
- •Written informed consent
排除标准
- •prior treatment for RCC
- •pregnant or nursing
- •history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- •evidence of metastatic disease
- •local and/or systemic infections requiring antibiotics within 28 days prior to study entry
- •other malignancy
研究组 & 干预措施
Nivolumab + Ipilimumab
Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab
Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 16 weeks
percentage of patients with localized RCC who have no tumor in kidney
次要结局
- Objective response rate(16 weeks)
- 3-year disease-free survival rate(3 years)
- 5-year survival rate(5 years)
- Rate of adverse events(16 weeks)