EUCTR2017-003302-40-PT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) AS ADJUVANT THERAPY AFTER DEFINITIVE LOCAL THERAPY IN PATIENTS WITH HIGH-RISK LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
F. Hoffman-La Roche Ltd.0 个研究点目标入组 406 人开始时间: 2019年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 406
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age >= 18 years
- •- Ability to comply with the study protocol, in the investigator's judgment
- •- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck SCCHN
- •- Human papillomavirus (HPV) status
- •- Completed definitive local therapy
- •- Absence of metastatic disease as documented by radiographic scans
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of study treatment. Women must refrain from donating eggs during this same period
- •- Confirmed response of CR, PR, or SD to definitive local therapy documented in radiographic scans = 8 weeks after completion of definitive local therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 325
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •- Patients who have received surgery alone or radiotherapy alone as definitive local therapy
- •- Patients with oropharyngeal or oral cavity cancer who have persistent disease at the primary site post-concurrent CRT or post-RT
- •- Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous histology
- •- Evidence of disease progression or metastatic disease during or following definitive local therapy documented in the post-definitive local therapy screening scans
- •- Uncontrolled or symptomatic hypercalcemia
- •- Active or history of autoimmune disease or immune deficiency
- •- Active tuberculosis
- •- Significant cardiovascular disease
- •- History of malignancy-, including prior SCCHN primary tumors (other than current SCCHN) within 5 years prior to screening, patients who have malignancies of a negligible risk of metastasis or death are eligible
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Current treatment with anti-viral therapy for HBV
- •- Prior neoadjuvant (i.e., induction) treatment or any systemic anti-cancer therapy without definitive local therapy for locally advanced head and neck cancer
- •- Treatment with systemic immunostimulatory agents
- •- Treatment with systemic immunosuppressive
- •- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment
- •- Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other non-FDA or non-EMA approved agent as part of definitive local therapy unless the unapproved agent was given in addition to an approved agent as part of an induction regimen or as part of concurrent therapy with radiotherapy
- •- Any systemic therapy after permitted definitive local therapies
研究者
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