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.

Zusammenfassung der Studie

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)

Untersuchte Intervention

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)

Untersuchte Krankheit(en)

Newly diagnosed glioblastoma multiforme (ndGBM, brain tumor)

(BASEC)

Sponsor

Novocure GmbH, Root, Switzerland IQVIA AG, Branch Basel, Basel, Switzerland

(BASEC)