DICIT: Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Objective response (OR) at week 9 (visit3/day64+5days), defined as a confirmed best response of either a complete response (CR) or a partial response (PR), as determined by investigator assessment using positron emission tomography in combination with computed tomography with contrast agent (diagnostic-quality PET-CT) according to the Response Evaluation Criteria in Solid Tumor, version 1.1 (RECIST 1.1.).
研究概览
简要总结
To evaluate the efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved SD as best response in metastatic melanoma patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, unresectable metastatic melanoma
- •Ongoing treatment with an approved anti-PD-1 therapy with a best response of SD according to (RECIST 1.1.)
- •Patients with BRAF-V600 mutations must have received targeted therapy
- •Availability of adequate tumor tissue accessible for biopsy
- •ECOG 0 or 1
- •Adequate organ function
排除标准
- •Active (symptomatic) brain metastases or leptomeningeal metastases
- •Uveal melanoma. Patients with conjunctival melanoma can be enrolled
- •Mucosal melanoma
- •History of heart failure NYHA III-IV
- •History of myocardial infarction or stroke
- •History of gastric ulcer or gastrointestinal bleeding
- •Known allergy or hypersensitivity to diclofenac
结局指标
主要结局
Objective response (OR) at week 9 (visit3/day64+5days), defined as a confirmed best response of either a complete response (CR) or a partial response (PR), as determined by investigator assessment using positron emission tomography in combination with computed tomography with contrast agent (diagnostic-quality PET-CT) according to the Response Evaluation Criteria in Solid Tumor, version 1.1 (RECIST 1.1.).
Objective response (OR) at week 9 (visit3/day64+5days), defined as a confirmed best response of either a complete response (CR) or a partial response (PR), as determined by investigator assessment using positron emission tomography in combination with computed tomography with contrast agent (diagnostic-quality PET-CT) according to the Response Evaluation Criteria in Solid Tumor, version 1.1 (RECIST 1.1.).
次要结局
- Not applicable
研究者
Department of Dermatology
Scientific
Universitaetsklinikum Regensburg