BO39633 - Atezolizumab open label extension study
Research type
Research Study
Full title
An open-label, multicenter extension and long-term observational study in patients previously enrolled in a Genentech - and/or F. Hoffmann La Roche LTD-sponsored Atezolizumab study
IRAS ID
225931
Contact name
Thomas Powles
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-005189-75
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Encouraging clinical data emerging in the field of tumor immunotherapy have demonstrated that therapies focused on enhancing T-cell responses against cancer can result in a significant survival benefit in patients with advanced malignancies.
Targeting the PD-L1 pathway with atezolizumab has demonstrated activity in patients with advanced malignancies who have failed standard-of-care therapies. Objective responses have been observed across a broad range of malignancies, including non−small cell lung cancer (NSCLC), urothelial carcinoma, renal cell carcinoma, melanoma, colorectal cancer, head and neck cancer, gastric cancer, breast cancer, and sarcoma.
This is an open-label, multicenter, non-randomized study to provide access to atezolizumab-based therapy or a comparator agent(s) for eligible patients who were previously enrolled and treated in an atezolizumab study (referred to as the parent study) that has been closed. At the same time, this study will continue to collect safety and survival data on patients treated on an atezolizumab-based therapy and on a comparator.
In consideration that patients with advanced or metastatic disease in the parent studies, and consequently in extension study, have limited alternative treatment options and based on investigator’s judgment, patients eligible for the extension study may potentially benefit from continued treatment with atezolizumab monotherapy or combined with other agent(s), in accordance with the parent study, and the potential benefits of participating in this extension study outweigh the potential associated risks.
A planned 556 patients will be enrolled globally with 7 patients in the UK at 2 sites.REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1592
Date of REC Opinion
9 Oct 2017
REC opinion
Favourable Opinion