KCT0004049撤回未知
A Phase II Study of Nivolumab in Combination with Radiation Therapy as Definitive Treatment for Patients with Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •?Age = 19 years
- •?Histologically or cytologically confirmed mucosal melanoma of head and neck
- •?Locally advanced and unresectable
- •?No previous chemotherapy for purpose of palliation
- •?ECOG performance status of 0~2
- •?Measurable lesion per RECIST 1.1 criteria
- •?Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained endoscopic biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded (FFPE) block specimens are preferred to slides.
- •?Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
- •?Collection of an archived tissue sample will also be requested (where available) to support evaluation of the clinical utility of biomarker assessment in newly obtained vs. archived tissue samples; however, a subject will not be precluded from participating in the study if an archived tissue sample is not available for collection or is otherwise insufficient for analysis.
- •?Adequate marrow, hepatic, renal and cardiac functions:
- •Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
- •Total serum bilirubin = 1.5 x ULN
- •Absolute neutrophil count (ANC) = 1,500/uL
- •Platelets = 100,000/uL
- •Hemoglobin = 8.0 g/dL
- •?Adequate renal function: Serum creatinine = 1.5 x UNL (upper normal limit)
- •?provision of a signed written informed consent
排除标准
- •?Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •?Active or history of autoimmune disease or immune deficiency, including MG, myositis, hepatitis, SLE, RA, IBD or GBS)
- •?Severe co-morbid illness and/or active infections
- •?Pregnant or lactating women
- •?History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
- •?Active CNS metastases not controllable with radiotherapy or corticosteroids
- •(however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
- •?Must not have undergone a major surgical procedure < 4 weeks or radiotherapy <2 weeks prior to D1 of treatment
- •?Administration of a live, attenuated vaccine within 4 weeks before study treatment
- •?Treatment with systemic immunosuppressive medication (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to D1 of treatment
研究者
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