STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma)
Research type
Research Study
Full title
A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
IRAS ID
196102
Contact name
Christopher Herbert
Contact email
Sponsor organisation
ImmunoCellular Therapeutics, Ltd
Eudract number
2015-002685-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
This is a double blind Phase III study where participants are randomised into 2 treatment arms following standard of care temozolomide. Participants randomised to arm one receive study therapy ICT-107 in combination with the standard of care temozolomide. Participants randomised to Arm 2 receive temozolomide with a blinded control version of study therapy (placebo). The primary aim of the study is to determine the overall survival of participants treated with study therapy and standard of care versus control participants treated with placebo and standard of care. All participants must be greater than 18 years of age and be HLA-A2+. All participants must have glioblastoma tissue available for tumour assessment for MGMT methylation status prior to randomisation. Participants will have had tumour resection and MRI prior to enrolment into the study. After consent, participants will undergo apheresis to collect peripheral blood mononuclear cells which will be used to make the study drug. The study has 4 stages: a 6 week post-surgery standard of care SOC treatment phase where participants receive radiotherapy and temozolomide, subjects then have a rest period where eligibility is reconfirmed and then (if eligible) they are randomised prior to a 4 week induction phase where study therapy is given weekly. This is followed by a maintenance phase where they receive study drug monthly for up to 11 months and then every 6 months until their disease progresses, they withdraw from the study, die, or the supply of study therapy runs out.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0114
Date of REC Opinion
9 May 2016
REC opinion
Further Information Favourable Opinion