Phase II Randomized Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas After One Prior Line of Systemic Therapy or Ineligible to Receive an Anthracycline-based Treatment
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
研究概览
简要总结
This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months
详细描述
The investigators hypothesize that the nivolumab alone or nivolumab plus pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months compared to historical controls of placebo and pazopanib alone respectively.
This is a randomized, Phase 2 study of nivolumab alone or nivolumab plus pazopanib in adult (≥ 18 years old) male and female subjects with unresectable or metastatic soft tissue sarcoma either ineligible to receive an anthracycline-based first line treatment or after one prior systemic therapy. Up to 33 and 46 subjects will be randomized (1:1) in the nivolumab and nivolumab plus pazopanib cohorts respectively, with a Simon two-stage design. Preliminary endpoint analysis will be performed when at least 18 subjects in the nivolumab cohort and 16 subjects in the nivolumab plus pazopanib cohort, have completed the first 12 cycles of nivolumab (6 months). Accrual duration is expected to be around 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of metastatic or unresectable soft tissue or bone sarcoma
- •No prior therapy with nivolumab in either cohorts or with pazopanib in the combination cohort
- •At least one line of systemic therapy or ineligibility for an anthracycline based chemotherapy
- •At least 2 distinct measurable metastatic sites
- •Adequate organ and marrow function as defined by initial laboratory tests
- •Life expectancy > 3 months
- •Stable brain metastases for at least 4 weeks and no steroid dependence
排除标准
- •Autoimmune disease Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drugs hazardous or obscure the interpretation of adverse events
- •Concomitant therapy with any non-study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigation therapies Chronic use of systemic corticosteroids greater than prednisone 10 mg daily or its equivalent
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 5 months after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding;
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness.
研究组 & 干预措施
Nivolumab
Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
干预措施: Nivolumab (Biological)
Nivolumab with Pazopanib
Pazopanib at a dose of 800mg by mouth daily.
干预措施: Nivolumab (Biological)
Nivolumab with Pazopanib
Pazopanib at a dose of 800mg by mouth daily.
干预措施: Pazopanib (Drug)
结局指标
主要结局
Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
时间窗: 6 Months
Time from randomization until disease progression or death
次要结局
- Measure of Tolerability(6 Months)
- Overall Response Rate(6 Months)
- Median Progression Free Overall Survival (OS)(6 Months)