CTRI/2022/05/042895尚未招募2 期
A phase 2 single arm study evaluating the safety and efficacy of fixed low dose nivolumab in advanced malignancy. - NI
I0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients unfit for standard cytotoxic chemotherapy due to poor performance status (ECOG PS >2 or organ dysfunction.
- •2. All patients with a diagnosis of advanced malignancy where nivolumab is approved at standard dose.
- •i. Metastatic Non-Small Cell Lung Cancer
- •ii. Advanced Renal Cell Carcinoma
- •iii. Advanced Squamous Cell Carcinoma of the Head and Neck
- •iv. Advanced Urothelial Carcinoma
- •v. Advanced Esophageal and Gastric Cancer with progression beyond standard fluoropyrimidine- and platinum-based chemotherapy.
- •3. Patients who have received the full dose of nivolumab but can no longer continue the standard dose of nivolumab due to financial or logistical constraints.
排除标准
- •1. Patients unwilling or incapable of giving informed consent.
- •2. Patients with prior nivolumab-induced immune-mediated severe adverse reactions.
- •3. Patients with prior nivolumab induced severe or life-threatening infusion-related reactions.
研究者
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