Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.
详细描述
The aim of the study was to demonstrate the efficacy and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer.
Scientific hypothesis: the combination of pembrolizumab and lenvatinib is effective and safe in patients with anaplastic thyroid cancer.
Trial design, materials and methods: this study is a pilot Phase 2 study. This study is prospective and open-label. Patients who meet the criteria will be treated with a combination of pembrolizumab and lenvatinib and outcomes will be assessed according to primary and secondary endpoints.
All patients will receive one regimen of antitumor treatment (exploratory therapy). The control will be carried out by monitoring the initial state in dynamics.
Before starting research therapy, data will be recorded for each patient in an individual registration card.
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
- •immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;
- •age ≥ 18 years;
- •functional status of ECOG 0-2;
- •adequate function of internal organs and bone marrow;
- •the ability to give written informed consent.
排除标准
- •patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
- •patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);
- •tumor invasion into large vessels;
- •patients with open wounds and fistulas;
- •contraindications to taking any of the studied drugs;
- •patients with poor functional status (ECOG 3-4);
- •continuous use of immunosuppressive therapy;
- •prior therapy with investigational drugs;
- •pregnancy, breast-feeding
研究组 & 干预措施
Intervention group
Treatment-naive patients with BRAF-negative anaplastic thyroid cancer and previously treated patients, including patients with BRAF-positive anaplastic thyroid cancer (resistant to anti-BRAF therapy).
干预措施: Pembrolizumab + Lenvatinib (Drug)
结局指标
主要结局
Objective response rate
时间窗: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.
Progression-Free Survival
时间窗: 6-month, 1-year, 2-year
The time from the date of treatment initiation to the radiological progression or death of the patient for any reason.
Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events)
时间窗: Each visit (every 21 days) assessed up to 48 months
Safety assessment will be assessed on the basis of adverse events (according to CTCAE 5.0)
次要结局
- Overall survival(6-month, 1-year, 2-year)
- The assessment of conversion to resectability(Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
研究者
Ernest Dzhelialov
Principal Investigator
Saint Petersburg State University, Russia