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NCT04492163
Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
Phase 2 trial testing TTFields in Glioblastoma Multiforme in 25 participants. Completed in 20 June 2023.
20 June 2023
Quick facts
| Lead sponsor | NovoCure GmbH |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 14 July 2020 |
| Primary completion | 20 June 2023 |
| Estimated completion | 20 June 2023 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- TTFields
Conditions studied
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
Sponsor
NovoCure GmbH — full company profile →
Who can join
18 and older, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma. The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Glioblastoma Therapy: Past, Present and Future.
Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529 -
Tumor-Treating Fields in Glioblastomas: Past, Present, and Future.
Guo X, Yang X, Wu J, Yang H, et al · · 2022 · cited 39× · PMID 35954334 · DOI 10.3390/cancers14153669 -
Targeting drug resistance in glioblastoma (Review).
Sherman JH, Bobak A, Arsiwala T, Lockman P, et al · · 2024 · cited 18× · PMID 38994761 · DOI 10.3892/ijo.2024.5668 -
Tumor treating fields for the treatment of glioblastoma: Current understanding and future perspectives.
Colamaria A, Leone A, Fochi NP, Di Napoli V, et al · · 2023 · cited 9× · PMID 38053701 · DOI 10.25259/sni_674_2023 -
Meta-Analysis of Modulated Electro-Hyperthermia and Tumor Treating Fields in the Treatment of Glioblastomas.
Szasz AM, Arrojo Alvarez EE, Fiorentini G, Herold M, et al · · 2023 · cited 9× · PMID 36765840 · DOI 10.3390/cancers15030880 -
Towards Effective Treatment of Glioblastoma: The Role of Combination Therapies and the Potential of Phytotherapy and Micotherapy.
Gaiaschi L, Bottone MG, De Luca F. · · 2024 · cited 8× · PMID 39727987 · DOI 10.3390/cimb46120859 -
Therapeutic potential of tumor treating fields for malignant brain tumors.
Zhou Y, Xing X, Zhou J, Jiang H, et al · · 2023 · cited 8× · PMID 36987739 · DOI 10.1002/cnr2.1813
Verify or expand the search:
- PubMed search for NCT04492163
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04218019 — Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation · NA · withdrawn
- NCT04717739 — TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study · unknown
- NCT04902586 — Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma · NA · unknown
- NCT04689087 — A Prospective, Open-label, Single-arm Clinical Study · NA · unknown
Other recruiting trials for Glioblastoma Multiforme
Currently open trials in the same condition.
- NCT06466031 — Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO] · NA · recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
- NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
- NCT06329570 — Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multif · Phase 1, PHASE2 · recruiting
Other NovoCure GmbH trials
Trials by the same sponsor.
- NCT06558799 — LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic · Phase 2 · active not recruiting
- NCT04892472 — EF-36/Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With P · Phase 2 · terminated
- NCT04953234 — Effect of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Best Standard of Care for the Treatment of Hospital · NA · completed
- NCT07319910 — Continued Access Program for Tumor Treating Fields (TTFields) Used With Chemotherapy (Gemcitabine and Nab-Paclitaxel) in · temporarily not available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04492163 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NovoCure GmbH
- Last refreshed: 16 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04492163.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing