IMA950 mixed with Poly-ICLC administered subcutaneously

Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly- ICLC administered subcutaneously

Glioblastoma Multiforme

Glioblastoma, Adult

Glioma of Brain

Glioblastoma Multiforme of Brain

IMA950/Poly-ICLC

IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab

IMA950/Poly-ICLC and pembrolizumab

University Hospitals of Geneva

Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

Pembrolizumab in Association With the Multipeptide Vaccine IMA950 Adjuvanted With Poly-ICLC for Relapsing Glioblastoma: a Randomized Phase I/ II Trial

To assess tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with pembrolizumab, using CTCAE v.4.03

To estimate 6, 9 and 12-month progression-free survival (PFS) using gadolinium-enhanced MRI and clinical assessment according to revised iRANO criteria

To estimate OS, defined as the time between the date of study entry and the date of death due to any cause. Subjects who have not died at the time of last known follow-up will be censored

Quality of life patient-reported outcomes (EORTC QLQ-C30 questionnaire)

To assess synergy/immunogenicity of IMA950 plus Poly-ICLC when given together with Pembrolizumab using Tumor Infiltrating Lymphocyte (TIL) density assessment

To assess synergy/immunogenicity of IMA950 plus Poly-ICLC when given together with Pembrolizumab by assessing vaccine-induced peripheral immune responses by flow cytometry or IHC as surrogate markers

Pierre-Yves Dietrich

Principal Investigator

University Hospital, Geneva

Patient with mass effective brain tumor that undergo non-invasive intracranial pressure measurement

Tumor, Brain

Intracranial Pressure Increase

Non-invasive measurement of intracranial pressure in patients with mass effective brain Tumors

Non-invasive measurement of intracranial pressure

Kantonsspital Aarau

non_invasive_aICP_Tumor

Non-Invasive Measurement of Absolute Intracranial Pressure in Patients With Mass Effective Brain Tumors

The primary outcome is the non-invasive, absolute intracranial pressure (aICP) before brain tumor surgery, as determined by the "NON-INVASIVE ICP ABSOLUTE VALUE METER" in mmHG.

The secondary outcome is to demonstrate correlation between increased aICP and clinical and radiological signs.

Javier Fandino, MD

There is 1 treatment arm with 4 dose cohorts in Phase I and 1 treatment arm in Phase IIa.

Recurrent High Grade Glioma

Eligible patients will receive Cerebraca wafer implantation with adjuvant temozolomide (TMZ) for the safety and efficacy in this study. At Phase I, the MTD will be determined by DLT. At Phase IIa, up to 12 evaluable patients will be enrolled for the efficacy and safety of Cerebraca wafer implantation. At Phase IIa, the cavity surface after tumor removal will be maximally covered by Cerebraca wafer without exceeding the MTD defined at Phase I. Patients in Phase I receive treatment as designed for Phase IIa, the data will be incorporated into Phase IIa to reduce the patient number. The overall patient number in this study is therefore between 2 to 36 evaluable patients.

Cerebraca wafer

Hualien Tzu Chi Hospital

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma

Everfront Biotech Co., Ltd.

It is a phase I/IIa study of Cerebraca Wafer, intracerebral implantation after resection of tumor, plus adjuvant Temozolomide (TMZ) in patients with recurrent high grade glioma (Grade III and Grade IV; anaplastic astrocytoma and glioblastoma multiforme).
Phase I: at least 2 patients and up to 24 patients. Phase IIa: 12 patients. The main study will end at 24 weeks after all patients receive Cerebraca Wafer implantation. If confirmation tumor response assessment is needed, additional 4 weeks study duration for Main Study Period is allowed. The clinical data at Main Study Period will be summarized in a Main Study Clinical Study Report (CSR).
All patients will be followed in the Extended Period for the efficacy and safety profiles until any one of study cut-off criteria is met, and a CSR will summarize the clinical data covering the overall study period.
NCI-CTCAE 4.03 will be used for grading of the toxicity of Cerebraca wafer.

NCI-CTCAE 4.03 will be used for grading of the toxicity (AE) of Cerebraca wafer.
Tumor response evaluation will be based on Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO).

Anaplastic Glioma

Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).
BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle.

Temodar and O6-Benzylguanine (BG)

The Preston Robert Tisch Brain Tumor Center at DUKE

astrocytoma/glavobolja

Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

non_invasive_aICP_Tumor

A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma

Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma

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