EUCTR2017-003302-40-FR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 400 人开始时间: 2018年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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 SCCHN [Human papillomavirus (HPV) positive Stage III or HPV negative Stave IVA or IVB based on American Joint Committee on Cancer 8th Edition Cancer Staging Manual] involving the oral cavity, oropharynx, larynx, or hypopharynx
- •HPV negative Stage IVA (T3/T4a+N2M0) regardless of tobacco use history
- •HPV negative Stage IVB (T3/T4a+N3M0 or T4b+N2/N3M0) regardless of tobacco use history
- •HPV-positive oropharyngeal carcinoma Stage III (clinical T1/T2+N3M0) and >=10 years of tobacco use history
- •HPV-positive oropharyngeal carcinoma Stage III (clinical T3/T4+N3M0 or pathologic T3/T4+N2M0) regardless of tobacco use history
- •- Human papillomavirus (HPV) status as determined locally by p16 immunohistochemistry, in situ hybridization, or by polymerase chain reaction-based assay
- •- Completed definitive local therapy and have scans 10-12 weeks after completion of definitive local therapy confirming either complete response, partial response, or stable disease and within 4 weeks of randomization
- •- Absence of metastatic disease as documented by radiographic scans
- •- Recovered from acute toxicities, except fatigue, xerostomia, dysgeusia, alopecia, associated with definitive treatment to Grade 1 or lower
- •- Patients with feeding tubes are eligible
- •- Availability of a representative pretreatment tumor specimen for exploratory biomarker research
- •- Eastern Cooperative Oncology Group performance status of 0 or 1
- •- Life expectancy >= 12 weeks
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •- Negative HIV test at screening
- •- Negative hepatitis B surface antigen test at screening
- •- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- •- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- 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
- •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 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- Patients who have received surgery alone as definitive local therapy
- •- HPV-negative patients who have a T1/T2 or N0/N1 tumor
- •- HPV-positive oropharyngeal carcinoma patients who have a clinical N0/N1/N2 or pathological N0/N1 nodal stage
- •- Patients, other than laryngeal cancer patients, who have persistent disease at the primary site and require salvage resection of primary tumor post chemoradiotherapy
- •- Squamous cell carcinoma of the nasopharynx
- •- Evidence of disease progression or metastatic disease during or following definitive local therapy documented in the 10- to 12-week post-definitive local therapy scans
- •- Uncontrolled or symptomatic hypercalcemia
- •- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- •- Active tuberculosis
- •- Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •- History of malignancy other than SCCHN within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ,or Stage I uterine cancer
- •- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- •- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- •- Current treatment with anti-viral therapy for HBV
- •- Prior neoadjuvant treatment or any systemic anti-cancer therapy without definitive local therapy for locally advanced head and neck cancer
- •- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug prior to initiation of study treatment
- •- Treatment with systemic immunosuppressive within 2 weeks prior to initiation of study treatment, or anticipation of need for sy
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