NP39487:Phase 1b study of RO6870810 and Atezolizumab in AOC or TNBC
Research type
Research Study
Full title
Open-label, dose finding and expansion Phase 1B study to evaluate the safety, pharmacokinetics and clinical activity of RO6870810 and atezolizumab (PD-L1 antibody) in patients with advanced ovarian cancer or triple negative breast cancer.
IRAS ID
247867
Contact name
Simon Lord
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-001147-13
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of of the study is to test the safety of RO6870810 when administered in combination with atezolizumab and to find out what effects, good or bad, these study drugs have on participants and their disease. Additionally, the effects of RO6870810/atezolizumab in the body, and particularly within the tumour, will be evaluated. The study also aims to find out if RO6870810/atezolizumab can slow down the growth or possibly shrink participants' tumours.
The study drugs used in this study act in different ways to prevent tumour cell growth and/or get rid of tumour cells:
•RO6870810 is a drug designed to inhibit expression of genes related to cancer by blocking the action of these genes and by preventing tumour growth or eliminating tumor cells.
•Atezolizumab is a drug that may help the immune system stop or reverse the growth of tumours.The combination of RO6870810 and atezolizumab is an experimental drug combination. This means that the Health Authorities have not approved this drug combination for the treatment of ovarian or breast cancer. Atezolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bladder cancer and lung cancer and for bladder cancer in Canada. RO6870810 has been tested in humans. However, this is the first time it will be administered in combination with atezolizumab.
There will be approximately 20 patients recruited at 3 UK sites.
The study is sponsored by F. Hoffman La Roche.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0252
Date of REC Opinion
21 Sep 2018
REC opinion
Further Information Favourable Opinion