EUCTR2017-003182-94-ES进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, PHASE II STUDY TO EVALUATE THE THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGETING FIBROBLAST ACTIVATION PROTEIN-? (FAP), IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1), ADMINISTERED INTRAVENOUSLY, IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS
Roche Farma S.A (Soc Unipersonal) que realiza el ensayo en España y actua como representante de F Hoffmann-La Roche LTD0 个研究点目标入组 256 人开始时间: 2017年11月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
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
- •- Participants who have progressed on at least one previous regimen of anticancer therapy
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- •- Eastern Cooperative Oncology Group Performance Status 0 or 1 or Karnofsky Performance Score >= 70
- •- Life expectancy of >= 12 weeks
- •- Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician
- •- Consent to provide an archival tumor tissue sample
- •- Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamic biomarker analysis
- •- Adequate cardiovascular, hematological, liver and renal function
- •- Adverse events related to any previous radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <= 1, except alopecia and Grade 2 peripheral neuropathy
- •- Participants with unilateral pleural effusion are eligible if they fulfill both of the following:
- •a) New York Heart Association Class 1
- •b) Global initiative for obstructive lung disease test level 1
- •- For male and female participants: The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment
- •- Participants with Gilbert’s syndrome will be eligible for the study. The diagnosis of Gilbert's syndrome is suspected in people who have persistent, slightly elevated levels of unconjugated bilirubin (<=3.0 × ULN) without any other apparent cause. A diagnosis of Gilbert’s syndrome will be based on the exclusion of other diseases on the basis of the following criteria:
- •a) Unconjugated hyperbilirubinemia noted on several occasions
- •b) No evidence of hemolysis and lactate dehydrogenase
- •c) Normal liver function tests
- •d) Absence of other diseases associated with unconjugated hyperbilirubinemia
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Symptomatic or untreated central nervous system (CNS) metastases
- •- History of treated asymptomatic CNS metastases
- •- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks before enrollment
- •- Leptomeningeal disease
- •- An active second malignancy
- •- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis
- •- Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration, including any of the following: hypertensive crisis/encephalopathy, uncontrolled hypertension, unstable angina, transient ischemic attack/stroke, congestive heart failure of any New York Heart Association classification, serious cardiac arrhythmia requiring treatment, history of thromboembolic events, hypertensive encephalopathy
- •- History of significant vascular disease
- •- Peripheral arterial thrombosis within 6 months before study treatment administration
- •- Active or uncontrolled infections
- •- Human immunodeficiency virus or hepatitis B, or hepatitis C virus infection
- •- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks before study treatment administration
- •- History of chronic liver disease or evidence of hepatic cirrhosis
- •- Serious, non-healing wound; active ulcer; or untreated bone fracture
- •- Dementia or altered mental status that would prohibit informed consent
- •- History of, active or suspicion of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- •- Participants with a history of autoimmune hypothyroidism on a stable dosage of thyroid replacement hormone may be eligible with approval by the Medical Monitor
- •- Participants with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study with approval by the Medical Monitor
- •- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field is permitted
- •- Bilateral pleural effusion confirmed by x-ray
- •- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- •- Concurrent therapy with any other investigational drug
- •- Immunomodulating agents
- •- Chronic use of steroids
- •- Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy.
- •- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
- •- Major surgery or significant traumat
研究者
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