Glioblastoma, recurrent/progressive
Conditions
Interventions
Trade Name: Opdivo
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nivolumab
CAS Number: SUB122750
Other descriptive name: NIVOLUMAB
Concentration unit: mg milligram(s)
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to make preliminary assessment of PD-L1 and other immune related biomarkers that might act as predictors of anti-tumor activity of Nivolumab.;Secondary Objective: •Assessment of the safety and tolerability of Nivolumab in combination with Bevacizumab for patients with current GBM. •To asses Progression-Free Survival (PFS) in treatment Arm A and Overall Response Rate (ORR), Duration of response (DOR) and Overall survival (OS) in treatment Arm B •Investigate the predictive ability of FET PET/MRI on response assessment with regard to PFS and OS. ;Primary end point(s): •The primary objective ist o make preliminary assessment of PD-L1 and other immune related biomarkers that might acta s predictors of antitumor activity of nivolumab ;Timepoint(s) of evaluation of this end point: The biomarklers analyses will be sampled during the first Weeks of therapy and at every evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 6-months Progression-free survival (6mPFS) rate (Progression of disease defined according to the iRANO criteria) • Response rate according to the iRANO criteria • Median progression-free survival (mPFS) • Median overall survival (OS) • Safety ;Timepoint(s) of evaluation of this end point: Patients will undergo physical and neurological examination every 4 weeks and MRI at baseline and MRI every 8 weeks. FET-PET MRI and perfusion CT will be performed at baseline and after 8-10 weeks. | — |
Countries
Denmark
Contacts
Public ContactUlrik Lassen
Rigshospilet
Outcome results
None listed