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Clinical Trial Results:
A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma - MIRAGE

Summary
EudraCT number	2017-003908-50
Trial protocol	BE GB DK DE NL ES AT
Global end of trial date	22 Aug 2022

Results information
Results version number	v1(current)
This version publication date	22 Feb 2023
First version publication date	22 Feb 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

EORTC-1709-BTG

ISRCTN number

US NCT number

NCT03345095

WHO universal trial number (UTN)

Sponsor organisation name

EORTC

Sponsor organisation address

83 Avenue Mounier, Brussels, Belgium, 1200

Public contact

Regulatory Affairs Department, European Organisation for the Research and Treatment of Cancer (EORTC), +32 27741013, thierry.gorlia@eortc.org

Scientific contact

Regulatory Affairs Department, European Organisation for the Research and Treatment of Cancer (EORTC), 027741652 27741013, thierry.gorlia@eortc.org

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Feb 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

09 Feb 2022

Global end of trial reached?

Yes

Global end of trial date

22 Aug 2022

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of this study is to compare overall survival in patients receiving Marizomib in combination with standard treatment with patients receiving standard treatment only.

Protection of trial subjects

The responsible investigator ensured that this study was conducted in agreement with either the Declaration of Helsinki (Tokyo, Venice, Hong Kong, Somerset West and Edinburgh amendments) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol was written, and the study was conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice . The protocol was approved by the competent ethics committee(s) as required by the applicable national legislation.

Background therapy

Standard arm(TMZ/RT): Standard radiotherapy (RT) (60 Gy in 30 fractions over 6 weeks) + TMZ 75 mg/m2p.o. daily for 6 weeks (duringRT) then (after 4-week break) up to 6 cycles of maintenance TMZ 150-200 mg/m2p.o. on days 1-5 of a 28-day cycle. All patients will have regular follow-up by MRI, 4 weeks after the end of RT, then every 8 weeks thereafter until progression. Once patients stop study treatment, they will be followed as per institution's standard.

Evidence for comparator

Experimental arm(TMZ/RT+MRZ): Standard radiotherapy ( RT)(60 Gy in 30 fractions over 6 weeks) + TMZ 75 mg/m2p.o. daily for 6 weeks (during RT) and marizomib (MRZ) dose 0.8 mg/m2IV at days 1, 8, 15, 29 and 36. This is followed, after 4-week break, by up to 6 cycles of maintenance TMZ 150-200 mg/m2p.o. on days 1-5 of a 28-day cycle and up to 18 cycles of maintenance MRZ treatment (0.8mg/m2IV) at days 1, 8, 15 of a 28-day cycle until disease progression, unacceptable toxicity or withdrawal of consent.

Actual start date of recruitment

18 Jun 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

22 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country