EUCTR2018-000254-21-DE进行中（未招募）1 期
Window of opportunity study of preoperative immunotherapy with atezolizumab (Tecentriq®) with or without tocilizumab (Actemra®) in local head and neck squamous cell carcinoma - PIONEER
niversity Hospital Essen0 个研究点目标入组 40 人开始时间: 2020年11月2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
- 40
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
- •Inclusion criteria
- •1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient. However, all screening examinations and laboratory results must have been obtained within 14 days before first study drug administration (initial tumor imaging: within 28 days before first study drug administration).
- •2. Only patients for whom sufficient tumor material to be judged by the local investigator and which is of adequate quality can be included into the trial. Please refer to section 6.5 for further details on quantity and quality of tumor samples.
- •3. Histologically or cytologically proven SCCHN (cT1-4a, cN0-3, cM0) that is amenable to surgical resection with curative intent based on the decision of the local multidisciplinary tumorboard.
- •4. Patients with relapse after primary radio(chemo)-therapy are allowed if a salvage surgery is possible (maximum 20%). Patients should have recovered from the effects of radiation: AE/sequelae should resolves to = grade 2 (no minimum recovery period required).
- •5. Male or female, 18 years of age or older on day of signing informed consent
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •7. Life expectancy >12 weeks
- •8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •Absolute neutrophil count (ANC) = 1.5E9/L without granulocyte colony-stimulating factor support
- •Lymphocyte count = 0.5E9/L
- •Platelet Count = 100E9/L without transfusion
- •Hemoglobin = 90 g/L
- •o Patients may be transfused to meet this criterion but patients in need of chronic or repeated RBC transfusion should be discussed with the sponsor before.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × upper limit of normal (ULN)
- •Serum bilirubin = 1.5 × ULN with the following exception:
- •o Patients with known Gilbert disease: direct serum bilirubin level = ULN for patients with total bilirubin Levels > 1.5 ULN.
- •Serum creatinine = 1.5 × ULN or Creatinine clearance = 30 mL/min (calculated using the Cockcroft-Gault formula)
- •Serum Albumin = 2.5 g/dL
- •International normalized ratio (INR) or activated Partial Thromboplastin Time (aPTT) = 1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on a stable dose
- •9. Women of childbearing potential:
- •Should have a negative urine or serum pregnancy test within 14 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after last study drug administration
- •A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a pos
排除标准
- •1. Evidence of metastatic disease (M1)
- •2. cT4b Stage
- •3. Prior treatment with immune checkpoint blockade therapies,
- •4. Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •5. Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 4 weeks prior to initiation of study treatment
- •6. Bilateral pleural effusion
- •7. Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1.
- •8. Treatment with a live-attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study, and for 5 months after the last dose of atezolizumab with or without tocilizumab
- •9. Treatment with systemic immuno-stimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment
- •10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •11. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment
- •12. Uncontrolled hypercalcemia
- •13. Uncontrolled tumor-related pain.
- •14. Uncontrolled diabetes mellitus
- •15. Pregnant and lactating women
- •16. Acute toxicities from previous therapy that have not resolved to Grade = 1, except for alopecia
- •17. Infections
- •a. Positive human immunodeficiency virus (HIV) test: Known HIV+ patients may be included
- •b. Active hepatitis B virus (HBV) infection (chronic or acute), positive HBsAg test at screening
- •Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening followed by a negative HBV DNA test, are eligible for the study. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
- •c. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening.
- •The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- •d. Active tuberculosis
- •e. Severe infection within 4 weeks prior to initiation of study treatment
- •f. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •g. Patients receiving prophylactic antibiotics are eligible for the study.
- •h. History of frequent severe diverticulitis.
- •18. Active or history of autoimmune disease or immune deficiency with the following exceptions:
- •- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study
- •- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- •- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible
- •19. Adverse events (AE) related to any previous radiotherapy, chemotherapy, targeted therapy or surgical procedure that have not reolved to Grade =1, except alopecia (any grade) and Grade 2 neuropathy
- •20. Prior allogeneic stem cell or solid organ transplantation
- •21. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computer tomography (CT) scan. History of radiation pneumonitis in the radi
研究者
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