EF-41/KEYNOTE D58

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1010027

• Contact name

  Alicia Williams

• Contact email

  awilliams@novocure.com

• Sponsor organisation

  Novocure GmbH

• Eudract number

  2024-513550-30

• Research summary

  Glioblastoma (GBM) is a very serious type of brain cancer that grows quickly and is hard to treat. It starts in the brain and can spread within the brain. Treating GBM usually involves surgery, radiation therapy combined with chemotherapy, and more chemotherapy afterwards. Despite these treatments, it is still very difficult to cure.
  To help fight this cancer, doctors are using a special device called Optune®, which creates Tumor Treating Fields (TTFields) that aim to kill brain cancer cells. This device is used along with a chemotherapy drug called temozolomide (TMZ) after patients have completed their initial radiation and chemotherapy treatment. In many countries, Optune is covered by (national) healthcare systems, but it is not covered by the NHS due to costs.
  This study aims to find out if adding another drug called pembrolizumab to the current treatment can help even more. Pembrolizumab is thought to boost the body’s immune system to fight the cancer. Researchers will compare two groups of patients: one group will receive TMZ, Optune®, and pembrolizumab, while the other group will receive TMZ, Optune®, and a placebo (a harmless substance that has no effect).
  Patients in the study will be chosen randomly, with two-thirds receiving the pembrolizumab treatment and one-third receiving the placebo. The study includes several phases: an initial screening and randomization, a treatment period where neither the patients nor the doctors know who is receiving the actual drug or the placebo, a visit to end treatment, a safety check 30-37 days after stopping treatment, and a follow-up phase.
  About 741 adult patients from around the world, who have been newly diagnosed with GBM and have already had surgery or a biopsy followed by radiation and TMZ treatment, will participate in this study. The goal is to find better ways to treat GBM and improve the lives of those affected by this difficult disease

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  24/LO/0660

• Date of REC Opinion

  19 Nov 2024

• REC opinion

  Further Information Favourable Opinion