CWoW - IMbrella B - Extension Study from Previous Atezolizumab Study
Research type
Research Study
Full title
An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)
IRAS ID
254093
Contact name
Peter Schmid
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2018-003352-20
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Atezolizumab has demonstrated anti-tumour activity in patients with different tumour types and is currently being investigated as a potential treatment across a wide range of malignancies. It is a humanised monoclonal antibody that inhibits the interaction between the programmed death receptor 1 ligand (PD-L1) present on tumour cells, and its receptors on T cells (PD-1 and B7-1). The result of this inhibition is an increase in the susceptibility of tumour cells to T-cell-mediated immune response.
The primary objective of this open-label study is to provide continued atezolizumab-based treatment for eligible patients who have previously participated in a Genentech or Roche-sponsored parent study. Only patients who demonstrate an acceptable safety profile at the time of the parent-study completion will be eligible to roll over. Patients with advanced or metastatic cancers may potentially benefit from continued treatment with atezolizumab monotherapy (single agent treatment), or atezolizumab in combination with other agent(s) or comparator agent(s), in accordance with the parent study.
It is expected that approximately 1000 male and female participants will be enrolled in 500 sites globally. Study treatment in this extension study will continue until disease progression, loss of clinical benefit, unacceptable toxicity or some other factor that necessitates discontinuation. The total duration of the study is expected to be approximately 10 years.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0068
Date of REC Opinion
26 Mar 2019
REC opinion
Further Information Favourable Opinion