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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
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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
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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
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Journal Article
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
2020
Overview
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.
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.
ISRCTN84434175. Registered 12 November 2018.
Publisher
BioMed Central Ltd,Springer Nature B.V,BioMed Central,BMC
Subject
/ Aged
/ Alopecia
/ Analysis
/ Antigens
/ Baldness
/ Brain Neoplasms - drug therapy
/ Brain Neoplasms - radiotherapy
/ Cytoreduction Surgical Procedures
/ Female
/ Glioma
/ Gliomas
/ Humans
/ Immune checkpoint inhibitors
/ Ipilimumab - administration & dosage
/ Ipilimumab - therapeutic use
/ Male
/ Multicenter Studies as Topic
/ Patients
/ Randomized Controlled Trials as Topic
/ Surgery
/ Temozolomide - administration & dosage
