Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Glioblastoma

Glioma

Death

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Avelumab 10 mg/kg intravenously (IV) every 2 weeks

Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Hypofractionated radiation therapy (HFRT)

Sylvia Kurz, MD

The purpose of this study is to test how safe and effective treatment with the combination of Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after chemotherapy.

The active pharmaceutical ingredient in Avelumab (MSB0010718C) is a fully human antibody of the immunoglobulin gamma-1 (IgG1) isotype that specifically targets and blocks the Programmed death-ligand 1(PD-L1) for Programmed cell death protein 1 (PD-1).

Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumor cluster of differentiation 8 (CD8)+ T cells, resulting in the restoration of cytotoxic T cell response.

Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma

A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma

Subjects are evaluable for DLTs (defined in section 5.2.1.2) if they have received at least one dose of Avelumab, have completed HFRT per protocol and have completed safety assessments over the entire DLT evaluation period (days 1 through 28).

PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression

OS will be determined from the time of treatment initiation until the time of death, with OS being censored at last follow-up if the patient remained alive

EMD Serono

NYU Langone Health

* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks

Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Avelumab and Hypofractionated Radiation Therapy(HFRT)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Sylvia Kurz, MD, PhD

Number of Dose Limiting Toxicities

Median Progression-free Survival (PFS6)

Median Overall Survival (OS)

Median Progression-free Survival (PFS12)

Overall Study

Oligodendroglioma

Oligoastrocytoma

study drug used to inhibit IDH1 mutation in these tumors, resulting in anti-tumor activity.

IDH305

Andrew S Chi, MD, PhD

The purpose of this study is to found out if the drug IDH305 is safe and effective in subjects with IDH1 mutant grade II or III glioma that has progressed after observation or radiation therapy.

IDH305 is an orally available, brain-penetrant, mutant-selective allosteric IDH1 inhibitor that blocks mutant IDH1-dependent production of 2-HG.

Trial of IDH305 in IDH1 Mutant Grade II or III Glioma

Phase 2 Study of IDH305 in Subjects With IDH1 Mutant Grade II or III Glioma That Has Progressed After Observation or Radiation Therapy

The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma	NCT02968940	Glioblastoma	Avelumab Hypofractionate...	18 Years -	NYU Langone Health
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma	NCT02968940	Glioblastoma	Avelumab Hypofractionate...	18 Years -	NYU Langone Health
Trial of IDH305 in IDH1 Mutant Grade II or III Glioma	NCT02977689	Glioma	IDH305	18 Years -	NYU Langone Health
Trial of IDH305 in IDH1 Mutant Grade II or III Glioma	NCT02977689	Glioma	IDH305	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for isocitrate dehydrogenase (idh)