Phase I-II study of nivolumab in combination with temozolomide and radiotherapy in children and adolescents with newly diagnosed high-grade glioma - NIVOGLIO

Gustave Roussy0 sites40 target enrollmentFebruary 20, 2019

Conditionsewly 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)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ewly diagnosed High-Grade Gliomas (HGG)
Sponsor: Gustave Roussy
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 20, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Gustave Roussy

Eligibility 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 \<18 years of age
•3\.Patients should be able and willing to comply with study visits and procedures as per protocol.
•4\.Patients must be affiliated to a social security system or beneficiary of the same according to local requirements
•5\.Sexually actice females of childbearing potential must have a negative serum pregnancy test within 24 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 5 months after the last study treatment administration. Sexually active males patients (and their female partner) must agree to use condom during the study and for at least 7 months after the last study treatment administration. Acceptable contraception is listed in Appendix 7\.
•6\.Newly diagnosed non\-brainstem WHO grade III and IV HGG and neuroglial tumors; gliomatosis cerebri or diffuse glioma, metastatic malignant glial tumors, multifocal gliomas and bithalamic gliomas are eligible for the study. Diffuse midline gliomas with H3K27M mutation are not eligible. Anaplastic ganglioglioma and anaplastic pleïomorphic astrocytoma will be eligible.
•7\.Local histological diagnosis has been confirmed centrally by a designated reference pathologist.
•8\.Able to commence trial treatment within 6 weeks following the last major surgery.
•9\.Adequate Bone Marrow Function : Hemoglobin ? 10 g/dL (transfusion independent), Neutrophil count ? 1\.0 ? 109/L. Platelet count ? 100 ? 109/L (transfusion independent)
•10\.Absence of Coagulation Disorder

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