YO42137 ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY)
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA
IRAS ID
286893
Contact name
Elizabeth Smyth
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-001178-31
Duration of Study in the UK
4 years, 0 months, 3 days
Research summary
Esophageal cancer is the seventh most commonly diagnosed cancer worldwide and the sixth most common cause of cancer-related death and will be responsible for an estimated 1 in every 20 cancer deaths in 2018. Most esophageal cancer patients are diagnosed with advanced disease and treatments can extend survival but are largely palliative; median survival time is less than 1 year. \n\nRecent studies have demonstrated that immunotherapy with drugs called checkpoint inhibitors for cancer can be helpful, however many patients treated with checkpoint inhibitors do not experience a prolonged benefit, highlighting the need to explore new treatments. The PD-L1 pathway is an immune checkpoint which temporarily reduces immune responses in states of inflammation like chronic infection or cancer. Atezolizumab is a drug which acts on PD-L1 to increase the body’s immune response to cancer and is already used in lung and bladder cancer. TIGIT is another pathway which reduces the activity of the body’s immune response. TIGIT is often found with PD-1 on immune cells (T cells) in multiple tumours, including esophageal cancer. In laboratory models, combined blockade of TIGIT and PD-L1/PD-1 pathways has been shown to be more effective compared with blockade of either pathway alone. The combination of tiragolumab (an anti-TIGIT antibody) plus atezolizumab was well tolerated (did not have significant side effects) in early phase trials, and the addition of tiragolumab did not change the safety profile (side effects) of atezolizumab, regardless of the tumour type.\n\nOverall, data suggest that combined interruption of the TIGIT and PD-L1 pathways is a promising option for patients with locally advanced squamous cell carcinoma. This trial will enroll patients with locally advanced esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and who have completed definitive concurrent chemo-radiation therapy.\n\n750 patients will be recruited globally with approximately 3-4 patients recruited at 9 UK sites. The study will last approximately 4 years (first patient screened to last patient last visit)\n\nStudy sponsored by F. Hoffman La Roche\nResearch Summary; Version Number 1 dated 14th April 2020\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0371
Date of REC Opinion
25 Nov 2020
REC opinion
Further Information Favourable Opinion