A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
详细描述
This is a study of the efficacy and safety of MTG201 given by intratumoral injection to patients with malignant pleural mesothelioma who have failed front line chemotherapy. Patients will also receive IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.
MTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.
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 confirmed locally advanced or metastatic pleural mesothelioma
- •Failed one prior treatment regimen including cisplatin-based chemotherapy
- •Eastern cooperative oncology group (ECOG) performance status; 0,1
- •Adequate organ function
- •Measurable disease per RECIST
排除标准
- •Candidate for surgical resection
- •has active autoimmune disease, primary or acquired immunodeficiency
- •significant cardiovascular disease
- •has active interstitial lung disease
- •has active infection or HIV, hepatitis B or C
- •previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy
- •other clinical significant disorder that could affect conduct of study
研究组 & 干预措施
MTG201 plus Nivolumab
Single arm, open-label, patients receive both MTG201 and nivolumab
干预措施: MTG201 (Drug)
MTG201 plus Nivolumab
Single arm, open-label, patients receive both MTG201 and nivolumab
干预措施: Nivolumab Injection [Opdivo] (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 3 months-2 years
Percentage of subjects with complete or partial response
次要结局
- duration of response (DUR)(up to 2 years)
- progression free survival (PFS)(up to 2 years)