BP40234: RO6874281 in combination with atezolizumab in solid tumours
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER, PHASE II STUDY TO EVALUATE THE THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGETING FIBROBLAST ACTIVATION PROTEIN-Α (FAP), IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1), ADMINISTERED INTRAVENOUSLY, IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS
IRAS ID
234886
Contact name
Colin Lindsay
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-003182-94
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
Reserach Study
This study aims to treat patients with advanced and/or metastatic solid tumours, initially in non-small cell lung cancer (NSCLC) but may expand to other cancers later. The main reason for the study is to see if RO6874281 improves and enhances the effect of Atezolizumab.
RO6874281 is an experimental drug that works by targeting a protein called fibroblast activation protein-α (“FAP”) which is present in virtually all solid tumours. RO6874281 activates the patient’s own immune system targeting the tumour. Atezolizumab works by blocking the protein PD-L1, giving the body’s defense mechanism the signal to attack cancer cells. By giving the two drugs together it is hoped that the effect on the tumour can be greater than giving the drugs on their own.
The study will start with two groups of 20 patients, all of which have had at least one treatment for their cancer. The type of prior treatment will define which of the two groups the patient will be enrolled into. RO6874281 will be given every week for four weeks and Atezolizumab every other week (so twice in four weeks). Starting from week 5, both drugs will be given every two weeks.
Blood and urine samples will be taken regularly for safety analysis, to see how the cancer is progressing, to determine how the drug(s) is processed and how long it takes to remove it from the body, and also how the body responds to the drug(s). Tumour samples will be taken, and scans of the tumour performed, to see how the cancer is progressing. Some genetic testing and additional samples will be taken to further understand both the disease and the drug(s).
Patients will be enrolled after some initial tests to ensure they are suitable to participate. They will continue on treatment while there is some benefit to them.
Summary of Results
: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdpyddsd5R0QY2jmPgDPHbHeitARyaPg1NX7vTXM0NYdusDh6YuLHN2Y1qXtRz46AkeTCrr8RWr5K6i0uckYZO2zbacp3i-2Bx-2Bn6dzJj6BdD6SY-3DoAs-_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKwPZ6YqojGh98Iqakc25rNaj16VfoC6jtUYAlVxDEzFws5GPjkBRH0-2BnOfW4NgjraFOENyy-2FBVQqne0Z6HC1UrVZviPeODgQuopyCDSbjC8SFOd9md2p5-2FdnTSiABhZFXlstr2vTXhUDHJAi97u-2FOySH9KE7vPAqS1otdtlF3-2BdQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0352334e351a41ac167e08da9d723b5b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637995411183354438%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=CG8OyOYisWkO9n3778g2r07WxSLF8mVpeLJd9BMBdfM%3D&reserved=0
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0436
Date of REC Opinion
27 Feb 2018
REC opinion
Further Information Favourable Opinion