An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Overall Response
研究概览
简要总结
The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.
详细描述
Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.
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, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
- •ECOG performance status ≤2
- •Patients must be able to swallow pills
排除标准
- •Nasopharyngeal and salivary gland tumors
- •Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
- •Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
- •Patients with uncontrolled intercurrent illness.
- •Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
研究组 & 干预措施
Niraparib & Dostarlimab
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
干预措施: Niraparib (Drug)
Niraparib & Dostarlimab
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
干预措施: Dostarlimab (Drug)
结局指标
主要结局
Overall Response
时间窗: 8 weeks
Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.
次要结局
- Rate of all Adverse Events(30 days after completion of treatment)
- Progression Free Survival(1 and 3 years)
- Overall Survival(5 years)
- Overall Survival(Through study completion, an average of 10 months)
研究者
Trisha Wise-Draper
Principal Investigator
University of Cincinnati