Novocure has enrolled the first patient in Phase 3 TRIDENT trial, evaluating Optune, a non-invasive, antimitotic cancer treatment, used concurrent with radiation therapy in newly diagnosed glioblastoma (GBM).
Optune plus maintenance temozolomide is currently indicated for the treatment of newly diagnosed, supratentorial glioblastoma in adults, following maximal debulking surgery and completion of radiation therapy, together with associated standard of care chemotherapy.
The Trident study is designed to enrol 950 newly diagnosed GBM patients who are eligible for radiation therapy and temozolomide, following surgery or biopsy.
Novocure chief medical officer Ely Benaim said: “We are excited to have begun our TRIDENT trial in newly diagnosed GBM. The TRIDENT trial represents our commitment to extending survival for GBM patients.
“We look forward to our partnership with the hundreds of patients who will participate in this study, their families and caregivers, and the nearly 100 leading institutions who have committed to this important research in GBM.”
In the study, the experimental group is planned receive Optune concurrent with radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide.
The control group will be given radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. The study participants will continue to receive Optune for 24 months or until second tumour progression, whichever occurs first.
Optune is designed to deliver Tumor Treating Fields to the region of the tumor and the device is intended to be used as a monotherapy.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, cause reduced damage to healthy cells.
According to preclinical studies, Tumour Treating Fields increase tumour sensitivity to radiation therapy and prevent DNA damage repair.
Tumour Treating Fields is approved for the treatment of adults with GBM in certain countries, and for MPM in the US.
