H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Rate of pathologic response
研究概览
简要总结
This is a multicenter, single arm Phase 2B study in subjects with locally advanced oral cavity squamous cell carcinoma (OCSCC) with surgically resectable disease. The study will assess the combination of neoadjuvant XL092 and pembrolizumab for safety and improvement of pathologic response rates compared to historical standard of care with perioperative pembrolizumab. The primary objective is to estimate the pathologic response rate defined as either pathological complete response (pCR), which is the absence of residual viable tumor, or major pathologic response (MPR), which is <10% of residual tumor following the completion of neoadjuvant therapy and surgery. The study will be conducted in two stages. Per Simon's Stage 1, 11 patients will be enrolled. Simon Stage 2 will be gated on multiple factors. If ≥2 pathologic response is observed (pCR or MPR), the trial will proceed with cohort expansion and enroll an additional 15 patients for a total of 26 patients.
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
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- •Age ≥ 18 years at the time of consent.
- •Tumors must have PD-L1 Combined Positive Score (CPS) ≥
- •ECOG or Karnofsky Performance Status of 0-1
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) within 30 days prior to treatment .
排除标准
- •Known HPV-positive cancer
- •Active infection requiring systemic therapy.
- •Prior treatment with XL-092
- •Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
研究组 & 干预措施
Locally advanced oral cavity squamous cell carcinoma
Locally advanced oral cavity squamous cell carcinoma (OCSCC) with surgically resectable disease.
干预措施: XL092 (Drug)
Locally advanced oral cavity squamous cell carcinoma
Locally advanced oral cavity squamous cell carcinoma (OCSCC) with surgically resectable disease.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Rate of pathologic response
时间窗: Up to 66 days
Rate of pathologic response, assessed following surgery, will be defined as either pathological complete response (pCR), which is the absence of residual viable tumor or major pathological response (MPR), which is \<10% residual tumor.
次要结局
- Neoadjuvant Adverse Events(Up to 66 days)
- Events Free Survival (EFS)(Up to 15 months)
- Objective response rate (ORR)(Up to 15 months)
- Time to surgery(Up to 66 days)
- Overall survival (OS)(Up to 15 months)