Study to evaluate the therapeutic effect of a cell based immune therapy targeting cancer stem cells i the malignant brain tumor glioblastoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Apr 2018 → ongoing

Decision date (initial)

2024-10-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-518663-35-00

EudraCT number

2015-002198-40

ClinicalTrials.gov

NCT03548571

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To identify the therapeutic effect of the product on progression free survival in glioblastoma patients.

Secondary objectives 1

1. To identify the effect of the product on overall survival, patient reported quality of life, immunological response and to identify adverse events.

Conditions and MedDRA coding

Glioblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Must be at least 18 years and less than 70 years of age.
2. Must be ambulatory with a ECOG performance status 0 or 1
3. Must have histologically confirmed glioblastoma IDH wild type, with non-methylated MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy ("Stupps Regimen").
4. Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA).
5. Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume.
6. Normal organ function defined by laboratory values.
7. Serology indicating contagious HIV, HBV, HCV and Treponema pallidum must be negative.
8. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion criteria 11

1. Tumor in a localization where a modest increase in size due to reactive edema may have a large impact on the patient's neurological condition, i.e. brain stem.
2. History of prior malignancy other than glioblastoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.
3. Active infection requiring antibiotic therapy.
4. Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
5. Prior splenectomy.
6. Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
7. Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
8. History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
9. Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination.
10. Positive pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose. Reliable methods of contraception are defined in section
11. Any reason why, in the opinion of the investigator, the patient should not participate.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months.
2. As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Einar Vik-Mo

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Trial Manager

Locations

1 EU/EEA country · 1 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 6 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