A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- MacroGenics
- 主要终点
- Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)
研究概览
简要总结
This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
详细描述
The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven, recurrent or metastatic SCCHN not curable by local therapy
- •No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior of given as part of multimodal treatment for locally advanced disease)
- •Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
- •At least one radiographically measurable lesion
- •HPV test results available (positive and negative eligible)
- •ECOG Performance status of 0 or 1
- •Adequate end organ function
- •Positive PD-L1 expression level (CPS ≥ 1%)
排除标准
- •Disease suitable for local therapy administered with curative intent
- •Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN
- •Radiation or other non-systemic therapy within 2 weeks of first dose of study drug
- •Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug
结局指标
主要结局
Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)
时间窗: Up to 30 days after last dose of study drug
Evaluation of adverse events and serious adverse events
Overall Response Rate (Modules X and Y)
时间窗: 2 years
Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1
次要结局
- Duration of Response - (Modules X and Y)(2 years)
- Immunogenicity (Module X)(2 years)
- Ctrough (Module X)(2 years)
- Ctrough (Module Y)(2 years)
- Progression-free Survival - (Modules X and Y)(2 years)
- Disease Control Rate - (Modules X and Y)(2 years)
- Immunogenicity (Module Y)(2 years)
- Cmax (Module Y)(2 years)
- Cmax (Module X)(2 years)