A study on patients with newly diagnosed glioblastoma to evaluate the efficacy and safety of Optune® (tumor treating fields, TTFields) in combination with temozolomide and pembrolizumab compared to Optune® (TTFields) in combination with temozolomide and placebo.
Summary description of the study
The currently approved treatment for ndGBM includes the addition of maintenance chemotherapy with temozolomide (TMZ) via Optune® after completion of radiotherapy and chemotherapy (RT + TMZ). This study aims to compare the effects of pembrolizumab in combination with Optune® and TMZ maintenance therapy versus placebo in combination with Optune® and TMZ maintenance therapy in treating patients with ndGBM. Optune® is a portable device consisting of the following components: a device to generate electric fields, 4 transducer arrays, and a power source. Transducer arrays consist of a medical cap with electrically isolated electrodes placed on the scalp where your primary tumor is located, delivering TTFields. TTFields is a treatment method for cancerous tumors. Laboratory studies have shown that this method can slow tumor growth without causing significant side effects. Extensive clinical studies have confirmed the safety and efficacy of Optune® in patients with recurrent and newly diagnosed GBM. TTFields may potentially enhance the immune response by sensitizing the tumor to immune checkpoint inhibitors such as pembrolizumab. Pembrolizumab is known as a checkpoint inhibitor that enhances the body's immune response against cancer cells. Pembrolizumab is approved in Switzerland as a medication for the treatment of various tumor types, but not for the treatment of ndGBM.
(BASEC)
Intervention under investigation
When standard radiotherapy and chemotherapy (RT + TMZ) is completed and the investigator has determined that all eligibility criteria for study participation are met, participants will be randomly assigned to one of two groups:
a. Optune® + TMZ + pembrolizumab.
b. Optune® + TMZ + placebo.
The likelihood of being assigned to the experimental group receiving Optune® + TMZ + pembrolizumab is twice as high. This study will be conducted as a double-blind study. This means that neither the treating physician nor the study participants know which treatment group they are assigned to. The placebo contains no active ingredient and is administered in the same way as pembrolizumab.
Pembrolizumab or placebo will be administered every 3 weeks at a dose of 200 mg. Pembrolizumab or placebo will be administered intravenously at the study center (infusion into a vein). Additionally, maintenance therapy with TMZ (temozolomide) will be administered during the treatment period.
At the start of the study, a Novocure Device Support Specialist (DSS) will instruct study participants on the proper use of Optune®. The Optune® treatment will be continuous for at least 18 hours per day (monthly average). Study participants may take breaks for personal needs (e.g., showering, array change) as long as treatment is provided for 18 hours per day (monthly average).
(BASEC)
Disease under investigation
Newly diagnosed glioblastoma multiforme (ndGBM, brain tumor)
(BASEC)
• Newly diagnosed GBM • Recovery after maximal debulking surgery (all patients with complete resection, partial resection, and only a biopsy are acceptable) • Completed standard adjuvant radiotherapy and chemotherapy with RT and concurrent TMZ chemotherapy (BASEC)
Exclusion criteria
with an active ingredient targeting another stimulating or co-inhibitory T-cell receptor • Ongoing need for > 2 mg dexamethasone (or an equivalent active ingredient) due to an intracranial mass effect • An additional malignancy that is progressing or required active treatment in the last 3 years (BASEC)
Trial sites
Basel, Lausanne, Zurich
(BASEC)
Sponsor
Novocure GmbH, Root, Switzerland IQVIA AG, Branch Basel, Basel, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Michael Weller
+41 44 255 55 00
michael.weller@clutterusz.chUniversitätsspital Zürich, Klinik für Neurologie, Frauenklinikstrasse 26, 8091 Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
20.12.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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