A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 9
- 主要终点
- Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
研究概览
简要总结
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.
详细描述
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of which play a role in tumor growth and progression of cancer.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib. The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase ll* of the overall study.
*Note: This Study was terminated prior to initiation of Phase II.
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 confirmed diagnosis of predominant clear cell renal cell carcinoma.
- •Advanced metastatic disease
- •Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- •For Phase l, no more than 3 prior anticancer regimens (IL-2 or interferon do not count towards the total).
- •Measurable (target) disease.
- •Life expectancy ≥ 12 weeks.
- •If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
- •Must have available tumor tissue and consent to biopsy while on study.
排除标准
- •Prior therapy with an anti-CD27 antibody.
- •Previous treatment with sunitinib.
- •Use of any experimental immunotherapy.
- •Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
- •Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
- •Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
- •Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
- •Active, untreated central nervous system metastases.
- •Active autoimmune disease or a documented history of autoimmune disease.
- •Active diverticulitis.
- •Significant cardiovascular disease including CHF or poorly controlled hypertension.
- •Impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
研究组 & 干预措施
Varlilumab and Sunitinib
干预措施: Combination of varlilumab and sunitinib (Drug)
结局指标
主要结局
Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
时间窗: Safety follow-up is 100 days from last study drug dose.
次要结局
未报告次要终点