UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Rate of serious adverse events
研究概览
简要总结
This single center phase 1 trial will study the combination of nivolumab+ipilimumab with embolization in participants with renal cell carcinoma. The study will evaluate the safety of embolotherapy in patients with metastatic RCC receiving nivolumab+ipilimumab. The hypothesis is that the number of serious adverse events will be no greater than the number of serious adverse events for both therapies combined.
详细描述
Previously untreated subjects with stage 4 RCC and unresected primary tumor or metastasis amenable to embolization will undergo two cycles of combination immune checkpoint inhibition (ICI) therapy, embolization of the target tumor, then resume ICI therapy. Study ends with safety and efficacy assessment at 6 months. Correlative blood and tissue specimens will be obtained.
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
- •Metastatic renal cell carcinoma with unresected primary tumor or with metastasis amenable to embolization.
- •No prior immune checkpoint therapy
- •Primary tumor or metastasis amenable to percutaneous embolization per review by the treating interventional oncologist
- •· Patent feeding artery to tumor > 2 mm diameter without macroscopic arteriovenous fistula/shunt
- •Additional metastatic site > 1 cm assessable for response by RECIST 1.1
- •Adequate organ function by screening laboratory studies within 30 days of embolization
- •platelets > 50K, correctable by transfusion
- •INR < 1.5, correctable by transfusion
- •creatinine < 2.0
- •ECOG performance status 0-2
- •Age ≥ 18 years
- •Have signed the current approved informed consent form and be willing and able to comply with this protocol
- •Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of study drug
- •Women of childbearing potential must have a negative serum or urine pregnancy test
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose
排除标准
- •Untreated CNS metastasis
- •Autoimmune disorder; 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
- •Immunodeficiency syndrome
- •Glucocorticoid (> 10 mg daily prednisone equivalents) or immunosuppressant therapy
- •Active infection requiring systemic therapy
- •Any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
- •Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- •Contrast allergy not mitigated by usual prophylaxis
研究组 & 干预措施
Ipilimumab +Nivolumab with Embolization
Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities.
Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.
干预措施: Nivolumab (Drug)
Ipilimumab +Nivolumab with Embolization
Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities.
Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.
干预措施: Ipilimumab (Drug)
Ipilimumab +Nivolumab with Embolization
Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities.
Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.
干预措施: bland embolization (Device)
结局指标
主要结局
Rate of serious adverse events
时间窗: Serious adverse events will be recorded from time of informed to consent to 100 days after the end of study intervention
SAE rate following embolization in patients
次要结局
- PD-L1(From baseline to 12 weeks post initiation of therapy)
- Objective response rate(Measured from baseline to 6 months post initiation)
- Characterization of immune cells(From baseline to 12 weeks post initiation of therapy)