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|NCT02866747 : A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
1. Age = 18 years at time of study entry.
2. Previous histopathologic confirmation of glioblastoma.
3. Any line of recurrence of glioblastoma proven by contrast enhanced Magnetic Resonance
Imaging (MRI) within 28 days prior to the first fraction of radiotherapy (RT), per
modified Response Assessment in Neuro-Oncology (RANO) criteria.
Note: Recurrence is defined as progression following therapy (i.e., chemotherapy,
radiation, second surgery).
4. Recurrent nodule of an histologically confirmed diagnosis of World Health Organization
(WHO) Grade IV malignant glioma (Glioblastoma) occurring in or out the previous
5. Recurrent disease documented by MRI evidence with a size of the recurrence evaluated
on T1 post-gadolinium sequence =35mm.
6. Patient for which a re-irradiation (by hFSRT) has been decided by the
multidisciplinary medical board.
7. Patients with measurable disease.
8. Prior radiotherapy must be ended at least 12 weeks before the first fraction of RT
(unless progressive disease outside of the radiation field or histopathologic
confirmation of unequivocal tumor to eliminate pseudoprogression images according to
9. In case of previous anti-Vascular Endothelial Growth Factor (VEGF)/Vascular
Endothelial Growth Factor Receptor (VEGFR) targeted therapy: at least 28 days between
the last injection of anti-VEGF/VEGFR targeted therapy and the first fraction of RT.
10. Karnofsky performance status =70.
11. Adequate hematologic, renal and hepatic function, as defined below:
- Absolute Neutrophil Count = 1500/mm3
- Haemoglobin = 9.0 g/dL
- Platelet count = 100,000/mm3
- Total bilirubin = 1.5 x Upper Limit of Normal (ULN) (for patient with confirmed
Gilbert's syndrome, Total bilirubin = 3 x ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN
- Creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 40 mL/min, using the
- Female CrCl = (140 - age in years) x weight in kilograms (kg) x 0.85 /72 x
serum creatinine in milligram/deciliter (mg/dL)
- Male CrCl = (140 - age in years) x weight in kg x 1.00/72 x serum creatinine
12. Female Patients must either be of non-reproductive potential (i.e., post-menopausal by
history: =60 years old and no menses for =1 year without an alternative medical cause;
or history of hysterectomy, or history of bilateral tubal ligation, or history of
bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
13. Written informed consent and any locally required authorization (e.g., Social security
for France (Health Insurance)) obtained from the patient prior performing any
protocol-related procedures, including screening evaluations.
14. Patient willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow
1. Multifocal glioblastoma multiforme (GBM) recurrence.
2. Distance between tumor and optic ways including chiasma or brainstem <1 cm.
3. Prior re-irradiation.
4. Prior exposure to Durvalumab or other anti-Programmed cell death 1(PD-1),
anti-Programmed death-ligand 1(PD-L1), anti-cytotoxic T-lymphocyte-associated protein
4 (CTLA4) antibodies.
5. Patient who received a live vaccine within 30 days prior to the first fraction of RT.
6. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,
endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal
antibodies, other investigational agent) within 28 days prior to the first fraction of
7. Current or prior use of immunosuppressive medication within 28 days before the first
fraction of RT (exception: systemic corticosteroids at physiologic doses not exceeding
10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication
for hypersensitivity reactions (eg, CT scan premedication) - Topical, inhaled, nasal
and ophthalmic steroids are not prohibited).
8. Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3
electrocardiograms (ECGs) using Fridericia's Correction
9. Presence of diffuse leptomeningeal disease or extracranial disease.
10. Active suspected or prior documented autoimmune disease (including inflammatory bowel
disease, celiac disease, irritable bowel syndrome, Wegener's granulomatosis and
Note: participants with vitiligo, type I diabetes mellitus, residual hypothyroidism
due to autoimmune condition only requiring hormone replacement, psoriasis not
requiring systemic treatment, or conditions not expected to recur in the absence of an
external trigger, are permitted to enroll.
11. Known primary immunodeficiency or active Human Immunodeficiency Virus (HIV).
12. Known active or chronic viral hepatitis or history of any type of hepatitis within the
last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or
hepatitis C virus antibody.
13. History of organ transplant requiring use of immunosuppressive medication.
14. History of active tuberculosis.
15. Current pneumonitis or interstitial lung disease.
16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
17. Other invasive malignancy within 2 years prior to entry into the study, except for
those treated with surgical therapy only.
18. History of severe allergic reactions to any unknown allergens or any components of the
19. Any prior Grade = 3 immune-related adverse event (irAE) or any prior
20. Participation in any other clinical trial involving another investigational product
within 4 weeks prior to the first fraction of RT.
21. Participation in any other clinical trial which delivered a dose >60 Gy for the
primo-treatment for glioblastoma.
22. Female patients who are pregnant, breast-feeding or male or female patients of
reproductive potential who are not employing highly effective method of birth control.
23. Any condition that, in the clinical judgment of the investigator, is likely to prevent
the patient from complying with any aspect of the protocol or that may put the patient
at unacceptable risk.
24. Mental impairment (psychiatric illness/social situations) that may compromise the
ability of the patient to give informed consent and comply with the requirements of
25. Patient who has forfeited his/her freedom by administrative or legal award or who is
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