Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma

NCT ID: NCT06222138

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2028-05-31

Brief Summary

This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields.

The study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial.

In this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation.

For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).

Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.

Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study.

Patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation.

MRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with newly diagnosed glioblastoma

Group Type: EXPERIMENTAL

The samples described below will be collected:

Intervention Type: OTHER

For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).

Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.

Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure.

Interventions

The samples described below will be collected:

For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).

Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.

Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years at the time of study entry.

2. Patient with newly diagnosed glioblastoma.

3. Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.

4. Signed written informed consent.

5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol

6. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria

1. Any condition contraindicated with sampling procedures required by the protocol.

2. Any contraindication to the use of the medical device administering TTFields.

3. Simultaneous participation in a therapeutic interventional clinical trial.

4. Patient pregnant, or breast-feeding.

5. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure

7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovoCure Ltd.

INDUSTRY

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IUCT-O

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elizabeth COHEN-JONATHAN MOYAL

Role: CONTACT

moyal.elizabeth@iuct-oncopole.fr

05 31 15 54 45

Facility Contacts

Elizabeth COHEN-JONATHAN MOYAL

Role: primary

moyal.elizabeth@iuct-oncopole.fr

05 31 15 54 45

Other Identifiers

23 TETE 04

Identifier Type: -

Identifier Source: org_study_id