TAMIGA - Bevacizumab GBM Study
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care (SOC) +/-continuous bevacizumab treatment following progression of disease (PD) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab
IRAS ID
126573
Contact name
Frank Saran
Contact email
Sponsor organisation
Emas Pharma Limited
Eudract number
2012-003138-17
Clinicaltrials.gov Identifier
Research summary
Glioblastoma (GBM) is one of the most aggressive malignant cancers of the brain. Its prognosis (chance of recovery) is very poor because complete removal with surgery is difficult. Therefore the majority of patients relapse (cancer comes back or progresses).
Standard 1st line treatment for newly diagnosed GBM is surgery followed by chemoradiation which is a combination of radiotherapy and chemotherapy (temozolamide). This combination has shown to increase the average survival for these patients. Recently the biologic agent bevacizumab (Avastin®) has been shown to lengthen the time before the cancer progresses when added to chemoradiation treatment.
At every relapse, chemotherapy (given as 2nd line and subsequent lines) remains the main treatment option. However there is currently no established regimen because no drug has shown to be better than the others. Patients therefore receive 2nd and subsequent chemotherapy lines in accordance with local standard of care. Avastin in combination with chemotherapy is currently approved in the United States to treat GBM that has come back after initial 1st line treatment.
Recent studies on different cancers have shown that patients may benefit from continuing Avastin after the cancer relapses in combination with subsequent lines of chemotherapy. To date, there has not been a large enough study describing the use of Avastin across multiple lines of therapy in GBM.
This study will therefore evaluate whether giving Avastin in combination with local standard of care chemotherapy as a 2nd-line and subsequent lines of treatment, improves survival in GBM patients who have progressed during or after 1st-line treatment with Avastin and standard chemoradiation therapy.
The study will also describe safety with regard to the long-term administration of Avastin, and the quality of life and symptoms improvement in a broad population of GBM patients.
The study will globally enrol 510 patients with newly diagnosed GBM over 2 years.
REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/1283
Date of REC Opinion
20 Oct 2013
REC opinion
Further Information Favourable Opinion