A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Stage 1: Number of Participants With Dose-limiting Toxicities
研究概览
简要总结
This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
详细描述
This was a non-randomized, open-label Phase 1b/2 study designed to evaluate safety, tolerability, and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with R/M HNSCC who were eligible for pembrolizumab monotherapy based on the current pembrolizumab prescribing information.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Duvelisib + Pembrolizumab
Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).
Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.
干预措施: Duvelisib (Drug)
Duvelisib + Pembrolizumab
Stage 1: Duvelisib twice daily (BID) for 1 week followed by combination therapy with duvelisib BID + pembrolizumab every 3 weeks (q3w) (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).
Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Stage 1: Number of Participants With Dose-limiting Toxicities
时间窗: 4 weeks or 28 days
Stage 1 and 2: Overall Response Rate (ORR)
时间窗: Up to 2 years
Proportion of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1).
Stage 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: 6 months
Number of participants with TEAEs as assessed by the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) as a measure of safety and tolerability of duvelisib in combination with pembrolizumab.
次要结局
- Stage 1 and 2: Progression-free Survival (PFS)(From start of treatment until documented PD or death (up to 2.5 years))
- Stage 1 and 2: Area Under the Curve [AUC](Up to 5 cycles (46 weeks))
- Stage 1 and 2: Overall Survival(From start of treatment until death (up to 2.5 years))
- Stage 1 and 2: Duration of Response (DOR)(From first response until documented PD (up to 2 years))
- Stage 1 and 2: Number of Participants With TEAEs(24 months)
- Stage 1: ORR(Until documented progressive disease (PD), unacceptable toxicity, discontinuation criteria are met, withdrawal, or death (up to 2 years))
- Stage 1 and 2: Maximum Observed Concentration [Cmax](Up to 5 cycles (46 weeks))