NCT04995016Unknown2 期
A Single-center, Non-randomized Controlled, Single-arm, Phase II Clinical Trial of Pembrolizumab and Axitinib as Neoadjuvant Therapy for Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma
Tianjin Medical University Second Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年8月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Major Pathologic Response (MPR)
研究概览
简要总结
This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of pembrolizumab combined with axitinib as neoadjuvant therapy for locally advanced non-metastatic clear cell renal cell carcinoma.
详细描述
This study is design to prospectively investigate the safety and efficacy of pembrolizumab combined with axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid on days 1-21 combined with pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
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 a renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon
- •Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor
- •The participant (or legally acceptable representative if applicable) provides written informed consent and the willingness and ability to comply with all aspects of the protocol
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Agree to collect tumor tissue, blood and other specimens required by this study and apply them to relevant studies
- •Important organs and bone marrow functions meet the following requirements: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet (PLT) ≥100×10^9/L, hemoglobin (HGB) ≥9g/dL;Liver function: serum total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times ULN, serum albumin (ALB) ≥ 2.8g /dL. Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min
- •Cardiac function met the following conditions: baseline electrocardiogram (ECG) had no evidence of PR prolongation or AV block
- •All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [beta-hCG]) at the screening visit and the baseline visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation
- •Male subjects who are partners of women of childbearing potential must use a condom and their female partners of childbearing potential must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drugs, throughout the entire study period, and for 120 days after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile
排除标准
- •Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- •Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
- •Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
- •Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment.
- •Subject is on any other form of immunosuppressive medication
- •Unable to swallow and retain orally administered medication
- •Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other -Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
- •Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
- •Presence of active infection requiring systemic therapy
- •Corrected QT interval duration prolongation
- •History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; --History of Class III or IV congestive heart failure according to New York Heart Association classification
- •History of cerebrovascular accident within the past 6 months
- •Poorly controlled hypertension
- •History of untreated deep venous thrombosis
- •Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
- •Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment
- •Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment
研究组 & 干预措施
Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma
Experimental
Neoadjuvant pembrolizumab plus axitinib
干预措施: Pembrolizumab (Drug)
Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma
Experimental
Neoadjuvant pembrolizumab plus axitinib
干预措施: Axitinib (Drug)
结局指标
主要结局
Major Pathologic Response (MPR)
时间窗: 12 weeks
The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), MPR is defined as %RVT\<10%
次要结局
- Objective response rate (ORR)(12 weeks)
- Pathologic Complete Response (pCR)(12 weeks)
- Incidence of treatment-related adverse events(AEs)(Up to 24 months)
- Disease-free survival(DFS)(Up to 24 months)
- Overall survival(OS)(Up to 24 months)
研究者
研究点 (1)
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