NL-OMON48737已完成不适用
PD-L1 PET/CT to predict durvalumab treatment response in HNSCC - PD-L1 imaging in HNSCC
niversitair Medisch Centrum0 个研究点目标入组 58 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations ;2. Age > 18 years at time of study entry, age > 20 years for Japanese subjects.;3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;4. Life expectancy of > 12 weeks;5. Adequate normal organ and marrow function as defined below: ;6. Haemoglobin * 9.0 g/dL;7. Absolute neutrophil count (ANC) * 1.5 x 109/L (> 1500 per mm3);8. Platelet count * 100 x 109/L (>100,000 per mm3);9. Serum bilirubin * 1.5 x institutional upper limit of normal (ULN). (This will not apply to subjects with confirmed Gilbert*s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician);10. AST (SGOT)/ALT (SGPT) * 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be * 5x ULN;11. Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:;12. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: *60 years old and no menses for *1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry. ;13. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.;14. Histological proven recurrent or metastatic squamous cell cancer of the head and neck ;15. At least one lesion with a tumor size * 1 cm
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study;2. Participation in another clinical study with an investigational product during the last 4 weeks;3. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab ;4. History of another primary malignancy except for:;a. Malignancy treated with curative intent and with no known active disease *5 years before the first dose of study drug and of low potential risk for recurrence;b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;c. Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ;5. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug 28 days prior to the first dose of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C). ;6. Mean QT interval corrected for heart rate (QTc) *470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia*s Correction;7. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid;8. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy) ;9. Any prior Grade *3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 ;10. Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave*s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.;11. Active or prior documented inflammatory bowel disease (e.g., Crohn*s disease, ulcerative colitis);12. History of primary immunodeficiency;13. History of allogeneic organ transplant ;14. History of hypersensitivity to durvalumab or any comparable agent;15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent;16. Known history of previous clinical diagnosis of tuberculosis;17. History of leptomeningeal carcinomatosis;18. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab;19. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;20. Any condition that, in th
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