First Site Activated and First Patient Randomised in new brain cancer study VIGOR – EORTC‑2427‑BTG

EORTC is pleased to announce the activation of the first site for the VIGOR study (EORTC-2427-BTG), a pivotal Phase III trial evaluating vorasidenib as maintenance treatment following completion of first-line chemoradiotherapy in patients with IDH-mutant glioma WHO CNS Grade 2 or 3 astrocytoma, worked in collaboration with Servier Affaires Médicales (NCT06809322).

In addition to the first site being activated, the study has already successfully randomised its first patient, marking a strong start to recruitment.

About the VIGOR Study

The VIGOR trial aims to determine whether vorasidenib, an oral brain-penetrant inhibitor of mutant IDH1/2 enzymes, can improve progression-free survival (PFS) compared to placebo, in patients who have completed standard chemoradiotherapy. This approach builds on promising results from the INDIGO trial, which demonstrated significant benefits in delaying disease progression in IDH-mutant gliomas. VIGOR adopts a rigorous design to validate these findings in a broader setting.

It is a Phase III study that is randomised, placebo-controlled, and triple-blind, intending to involve around 470 patients across multiple international sites. The primary endpoint focuses on progression-free survival (PFS) assessed using the RANO 2.0 criteria, while secondary endpoints include overall survival (OS), time to next intervention, safety and adverse events, and health-related quality of life measures, ensuring a comprehensive evaluation of the treatment’s impact.

The VIGOR trial is coordinated by Dr. Matthias Preusser (Medical University of Vienna, Austria) and co-coordinated by Dr. Marjolein Geurts (Erasmus MC Cancer Institute, Rotterdam, The Netherlands).

Dr. Preusser says:

“The VIGOR trial has the potential to define a new standard of care for patients with IDH-mutant gliomas and will provide valuable new insights and opportunities for further research to improve the diagnostic and therapeutic possibilities for this disease”.

Dr. Geurts:

“The randomization of the first patient in the VIGOR study is an exciting and important milestone for patients with IDH-mutant astrocytoma. It reflects the strong collaboration and shared commitment to improving outcomes and expanding treatment options early in the disease course. We are very much looking forward to the next milestones as we work together to make a real difference for patients and their families”

Why this study matters

Patients with IDH-mutant astrocytoma typically experience long survival but face inevitable recurrence. VIGOR seeks to establish whether maintenance therapy can extend the time before progression and reduce the need for subsequent interventions, improving long-term outcomes and quality of life.

The activation of the first site, and the successful randomisation of the first patient, represent early and encouraging milestones in this international effort. Recruitment will expand across more than 50 leading cancer centres in Europe and beyond, with EORTC coordinating the study, in collaboration with the Canadian Cancer Trials Group (CCTG) and the Cooperative Trials Group for Neuro-Oncology (COGNO).