Newly diagnosed High-Grade Gliomas (HGG) MedDRA version: 20.0 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Nivolumab
Product Code: BMS-936558
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Nivolumab
Other descriptive name: NIVOLUMAB
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines 2. Age at inclusion: ? 3 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any disease or condition that contraindicates the use of the study medication/treatment (for TMZ, see the approved product labelling) or places the patient at an unacceptable risk of experiencing treatment related complications. 2. Patients should not be on high-dose steroids (ie > 1mg/kg) before study entry; doses should be stable for at least two weeks or decreasing. 3. Low probability of protocol compliance. 4. Radiological evidence of surgically related intracranial bleeding (excluding asymptomatic, resolving hemorrhagic changes associated with recent surgery and the presence of punctuate hemorrhage in the tumor). 5. Subjects with concommitant second malignanices are excluded unless a complete remission is achieved as it is empirically determined based on the malignancy and treatment provided prior to study entry and no additional therapy is required or anticipated to be required during the study period. 6. Previous cranial irradiation. 7. Any known auto-immune disease, previous or ongoing. 8. Known chronic inflammatory digestive disease, previous or ongoing. 9. Chronic asthma receiving corticotherapy, even only with inhalation. 10. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of study drug 11. Pregnant or breastfeeding women 12. Known hypersensitivity to any component of the products (study drug or ingredients) 13. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening). 14. Patients who are currently receiving another investigational drug or anticancer agent 15. Patient who have an uncontrolled infection 16. Patient with known human immunodeficiency virus (HIV) / AIDS infection or acute / chronic Hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be to evaluate the feasability of nivolumab administration when added to postoperative radiotherapy with concomitant and adjuvant temozolomide and to determine whether the addition of nivolumab to the initial management of pediatric patients with newly diagnosed supratentorial high-grade glioma shows a signal of clinical benefit.;Secondary Objective: i)To assess clinical benefit with alternative efficacy outcomes ii)To assess response to treatment ;Primary end point(s): Assessment of Toxicity and Safety according to NCI – CTCAE v5.0 (proportion of DLT) ;Timepoint(s) of evaluation of this end point: First 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 months after the end of treatment;Secondary end point(s): i) 1-year Overall Survival (OS) ii) 6 month EFS, iii) Best response rate according to the RANO criteria. When the pediatric criteria will be available, they will be incorporated in the response assessment iv) Immune-related response criteria (irRC) | — |
Countries
France, Italy, United Kingdom
Contacts
Public ContactSponsor CRA
Gustave Roussy
Outcome results
None listed