Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Completing Study Treatment
研究概览
简要总结
This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.
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
- •Non metastatic GEC including locally advanced unresectable
- •Treatment naïve
- •Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES
- •MSI-Stable or pMMR
- •Age ≥ 18 years
- •Body weight > 66 pounds
- •Repeat biopsy feasible
- •No clinically significant autoimmune disease
排除标准
- •Patients with known metastatic disease
- •Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma
- •Patients with uncontrolled autoimmune disease per investigator discretion
- •Inability or refusal to undergo biopsy procedures to obtain tissue samples
研究组 & 干预措施
Tremelimumab and Durvalumab
Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
干预措施: Tremelimumab (Drug)
Tremelimumab and Durvalumab
Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
干预措施: Durvalumab (Drug)
结局指标
主要结局
Percentage of Subjects Completing Study Treatment
时间窗: 2 Years
Percentage of Subjects Completing the Study Treatment
Percentage of Subjects Completing Post-Treatment Biopsy
时间窗: 2 Years
Percentage of Subjects Completing the Post-Treatment Biopsy
次要结局
- Percent Change in the Proportion of Intra Tumoral Effector T-cells(2 years)
- Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.(2 years)
- Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events(2 years)
- Comparison of T-Cell Infiltration in Various Tumor Mutations(2 years)
研究者
Farshid Dayyani
HS Associate Clinical Professor, Department of Medicine, Division of Hematology, Oncology
University of California, Irvine