Trial on efficacy and safety of vaccination of newly diagnosed glioblastoma patients with the patient's own immune cells.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Heinrich-Heine-Universitaet Duesseldorf

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Mar 2018 → ongoing

Decision date (initial)

2024-08-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bundesministerium für Bildung und Forschung (BMBF)

External identifiers

EU CT number

2024-514820-18-00

EudraCT number

2017-000304-14

ClinicalTrials.gov

NCT03395587

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective of the study is to determine whether overall survival of newly diagnosed GBM patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone.

Secondary objectives 1

1. Secondary objectives are comparing progression-free survival and 6, 12 and 24 month OS and PFS rates, the safety profile, overall and neurological performance and the quality of life between the two treatment groups.

Conditions and MedDRA coding

newly diagnosed glioblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV), including the histological variants of gliosarcoma and giant cell glioblastoma, confirmed by central neuropathologist according to the WHO classification of central nervous system tumors 2016. Tumors may cross into, but not beyond the corpus callosum.
2. Near-complete resection (≤ 5 ml residual contrast enhancing tumor volume) confirmed by central neuroradiologist on MRI scan within 72 h postoperative; awake surgery and second look surgery are possible, if medically indicated.
3. Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production.

Exclusion criteria 1

1. Severe acute or chronic medical conditions that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of trial results and, in the opinion of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to the following: Immunosuppressive disease / immunodeficiency, Chronic renal disease / failure, Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia, Severe poorly controlled diabetes, Planned other major surgery.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint is OS measured from the day of surgery until death.

Secondary endpoints 5

1. PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause.
2. OS and PFS rates at 6, 12 and 24 months after the day of surgery.
3. Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03.
4. Overall and neurological performance as determined by the KPS and the MMSE-2.
5. Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Heinrich-Heine-Universitaet Duesseldorf

Sponsor organisation

Heinrich-Heine-Universitaet Duesseldorf

Address

Universitaetsstrasse 1, Bilk Bilk

City

Duesseldorf

Postcode

40225

Country

Germany

Scientific contact point

Organisation

Heinrich-Heine-Universitaet Duesseldorf

Contact name

Prof. Dr. Michael Sabel

Public contact point

Organisation

Heinrich-Heine-Universitaet Duesseldorf

Contact name

Prof. Dr. Michael Sabel

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications