NL-OMON46250已完成不适用
Bioimmunoradiotherapy (BIR) with concurrent Avelumab, Cetuximab and Radiotherapy as first line treatment in patients with locally advanced squamous cell carcinoma of the head and neck. A feasibility study in patients unfit for cisplatin - N16BIR
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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. Be willing and able to provide written informed consent for the trial.
- •2. Be *18 years of age on day of signing informed consent.
- •3. WHO Performance Status 0-2
- •4. Histologically confirmed Locally Advanced (i.e. stage III or IV) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
- •5. Unfit for concurrent chemoradiation with cisplatin, e.g. GFR < 60 ml/min, cardiovascular co-morbidity, hearing loss or polyneuropathy or written confirmed unwillingness for treatment with chemotherapy
- •6. Willingness to provide tissue for tumor microenvironment analysis from archival tumor material or newly obtained core or excisional biopsy and willingness to provide a core or excisional biopsy at day 14 (±2 days) after start of treatment.
- •7. At least one measurable lesion as defined by RECIST 1.1.
- •8. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •9. Adequate bone marrow, renal and liver function.
- •10. Serum pregnancy test (for females of childbearing potential) negative at screening.
- •11. Highly effective contraception for both male and female subjects if the risk of conception exists.
排除标准
- •1. The following prior therapies are excluded:
- •* Prior systemic therapy, radiotherapy or surgery directed at locally advanced SCCHN.
- •* Prior immunotherapy with IL-2, IFN-*, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •2. A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •3. Current or prior use of immunosuppressive medication within 7 days prior to
- •randomization, (see protocol for exceptions)
- •4. Known severe hypersensitivity reactions to monoclonal antibodies (Grade *3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma).
- •5. Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
- •6. Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (eg, surgery, radiation, or castration).
- •7. Significant acute or chronic infections.
- •8. Prior organ transplantation, including allogeneic stem cell transplantation
- •9. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, but
- •a. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •b. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses * 10 mg or 10 mg equivalent prednisone per day
- •c. Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable
- •10. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade * 2 is acceptable
- •11. Pregnancy or lactation
- •12. Known alcohol or drug abuse
- •13. All other significant diseases, which, in the opinion of the Investigator, might impair the subject*s tolerance of trial treatment
- •14. Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •15. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines).
- •16. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism.
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