A phase II Open Label, two-armed Translational Study of Nivolumab in Combination with Bevacizumab for Recurrent Glioblastoma - Nivo-Bev-ITT-01

Rigshospitalet0 个研究点目标入组 40 人开始时间: 2017年12月13日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•1.Pathologically confirmed GBM (including all histologic variants);
•2.Age = 18 years;
•3.Evidence of radiological (MRI-scan) measurable recurrent progressive GBM evaluated by the Response Assessment in Neuro-Oncology [RANO] criteria;
•4.Measurable disease according to the RANO guidelines, within 14 days of starting treatment. Measurable disease after surgery on arm A is not required with radiographic evidence of recurrent disease after treatment with temozolomide and radiotherapy;
•5.An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrolment on this protocol;
•6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
•7.Life expectancy, in the opinion of the investigator > 3 month;
•8.Written informed consent obtained prior to any screening procedures. Patients must be willing and able to comply with the protocol and aware of the investigational nature of this study;
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1.Patients must not have significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy;
•2.Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids (equivalent to max dose of 20 mg prednisolone per day) and stable for at least 5 days prior to day 1;
•3.Any condition (medical, social, psychological), which would prevent adequate information and follow-up;
•4.Any other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ;
•22.History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner´s granulomatosis, Sjögren´s syndrome, Bell´s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis;

发起方