A phase II open label, randomised study of ipilimumab with temozolomide versus temozolomide alone after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma: the Ipi-Glio trial protocol
Nicholas F. Brown,
Stasya M. Ng,
Claire Brooks,
Tim Coutts,
Jane Holmes,
Corran Roberts,
Leena Elhussein,
Peter Hoskin,
Tim Maughan,
Sarah Blagden,
Paul Mulholland
Affiliations
Nicholas F. Brown
Department of Oncology, University College London Hospitals
Stasya M. Ng
Oncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford
Claire Brooks
Oncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford
Tim Coutts
Oncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford
Jane Holmes
Centre for Statistics in Medicine (CSM), University of Oxford
Corran Roberts
Centre for Statistics in Medicine (CSM), University of Oxford
Leena Elhussein
Centre for Statistics in Medicine (CSM), University of Oxford
Peter Hoskin
Mount Vernon Cancer Centre
Tim Maughan
Oxford Institute for Radiation Oncology, University of Oxford
Sarah Blagden
Department of Oncology, University of Oxford
Paul Mulholland
Department of Oncology, University College London Hospitals
Abstract Background Median survival for patients with glioblastoma is less than a year. Standard treatment consists of surgical debulking if feasible followed by temozolomide chemo-radiotherapy. The immune checkpoint inhibitor ipilimumab targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and has shown clinical efficacy in preclinical models of glioblastoma. The aim of this study is to explore the addition of ipilimumab to standard therapy in patients with glioblastoma. Methods/design Ipi-Glio is a phase II, open label, randomised study of ipilimumab with temozolomide (Arm A) versus temozolomide alone (Arm B) after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma. Planned accrual is 120 patients (Arm A: 80, Arm B: 40). Endpoints include overall survival, 18-month survival, 5-year survival, and adverse events. The trial is currently recruiting in seven centres in the United Kingdom. Trial registration ISRCTN84434175 . Registered 12 November 2018.
