WO42017 - A Study of Tiragolumab and Atezolizumab in Cervical Cancer
Research type
Research Study
Full title
A PHASE II, SAFETY, AND EFFICACY STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB AND ATEZOLIZUMAB MONOTHERAPY IN PATIENTS WITH METASTATIC AND/OR RECURRENT PD-L1−POSITIVE CERVICAL CANCER
IRAS ID
279393
Contact name
Mary McCormack
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-004895-21
Duration of Study in the UK
3 years, 7 months, 31 days
Research summary
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer-related death.More than 569,847 women are diagnosed with cervical cancer annually worldwide.Treatment for early and locally advanced cervical cancer consists of surgery&definitive chemoradiotherapy,respectively,and can be quite effective in eliciting a remission.However,if cancer recurs or fails to resolve with primary treatment,prognosis is quite poor.
With few exceptions,the standard of care for recurrent,persistent,or de novo metastatic disease is chemotherapy plus bevacizumab.Currently, no globally-accepted standard of care exists after recurrence or progression on chemotherapy plus bevacizumab.As such, treatment options for these patients largely comprise various cytotoxic chemotherapy agents, administered as either a single agent or in combination.However, given the historically low response rates of approximately 10%-15%, increasing focus has been given to whether cytotoxic chemotherapies represent an acceptable standard of care over best supportive care given the impact and burden such agents can impart on patient quality of life.
TIGIT(a receptor found on the surface of activated T-Cells)is expressed in a wide variety of human tumours and is highly correlated with T-cell infiltration and PD-1 expression. Tiragolumab is a monoclonal antibody that binds TIGIT and is being investigated as a potential therapy against tumours in humans.
Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1.Atezolizumab is being investigated as a potential therapy in a wide variety of malignancies both as a single agent as well as in combination with other therapies.
This Phase II study will evaluate the safety and efficacy of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with metastatic and/or recurrent PD-L1-positive cervical carcinoma.160 patients will be recruited globally with approximately 20 from the UK across 5 sites.The study will last approximately 36 months from FPI to LPLV.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1(30-Jan-2020)REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0545
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion