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

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 s...

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Autores principales: Brown, Nicholas F., Ng, Stasya M., Brooks, Claire, Coutts, Tim, Holmes, Jane, Roberts, Corran, Elhussein, Leena, Hoskin, Peter, Maughan, Tim, Blagden, Sarah, Mulholland, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Study Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7068928/
https://www.ncbi.nlm.nih.gov/pubmed/32164579
http://dx.doi.org/10.1186/s12885-020-6624-y
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author Brown, Nicholas F.
Ng, Stasya M.
Brooks, Claire
Coutts, Tim
Holmes, Jane
Roberts, Corran
Elhussein, Leena
Hoskin, Peter
Maughan, Tim
Blagden, Sarah
Mulholland, Paul
author_facet Brown, Nicholas F.
Ng, Stasya M.
Brooks, Claire
Coutts, Tim
Holmes, Jane
Roberts, Corran
Elhussein, Leena
Hoskin, Peter
Maughan, Tim
Blagden, Sarah
Mulholland, Paul
author_sort Brown, Nicholas F.
collection PubMed
description 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.
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spelling pubmed-70689282020-03-18 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 Brown, Nicholas F. Ng, Stasya M. Brooks, Claire Coutts, Tim Holmes, Jane Roberts, Corran Elhussein, Leena Hoskin, Peter Maughan, Tim Blagden, Sarah Mulholland, Paul BMC Cancer Study Protocol 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. BioMed Central 2020-03-12 /pmc/articles/PMC7068928/ /pubmed/32164579 http://dx.doi.org/10.1186/s12885-020-6624-y Text en © The Author(s). 2020 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Brown, Nicholas F.
Ng, Stasya M.
Brooks, Claire
Coutts, Tim
Holmes, Jane
Roberts, Corran
Elhussein, Leena
Hoskin, Peter
Maughan, Tim
Blagden, Sarah
Mulholland, Paul
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7068928/
https://www.ncbi.nlm.nih.gov/pubmed/32164579
http://dx.doi.org/10.1186/s12885-020-6624-y
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