A Personalised Cancer Vaccine study in Patients with Advanced Tumours.
Research type
Research Study
Full title
A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors.
IRAS ID
229481
Contact name
Thomas Powles
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2017-001475-23
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The body’s immune system has the ability to recognise and fight harmful infections and cancer. However, tumours can affect the way the immune system normally works and this helps tumours grow. The goal of a personalised cancer vaccine (PCV) is to help train the body’s immune system to recognise and attack cancer cells. As the immune system has memory, it is hoped that once trained, the immune cells will continue to work long after the vaccine is given. This is a study of an experimental treatment using a PCV called RO7198457, in patients with locally advanced or metastatic cancer. The study will test the safety of PCV in two parts: the first part (phase 1a) will test PCV alone and the second part (Phase 1b) will test PCV given with atezolizumab, a cancer immunotherapy drug. PCV will be given at different dose levels to find out what effects the combination of PCV and atezolizumab has on patients cancer. Atezolizumab alone and in combination with other anti cancer drugs has been tested in humans with advanced cancer, but the specific combination of PCV and atezolizumab has not been tested in humans before.
This study will enrol patients whose cancers have grown or spread and/or did not respond to previous treatment(s); or for which previous treatment(s) was stopped because the side effects were not tolerable; or for which a clinical trial of an experimental drug, is considered acceptable to treat their disease.
Both Phase Ia and Phase Ib parts consist of a two-part screening period, a treatment period, and a post-treatment follow-up period.
Study procedures include: vital signs, physical examination, ECG, blood samples for laboratory tests, tumour biopsy and radiographic assessments to monitor the disease.
Approximately 209-572 patients will be enroled into this study at approximately 20-40 sites globally. The study is sponsored by Genentech, Inc.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0311
Date of REC Opinion
1 Dec 2017
REC opinion
Further Information Favourable Opinion