WO39210 - Atezolizumab in patients with renal cell carcinoma
Research type
Research Study
Full title
A phase III, multi-centre, randomized, placebo-controlled, double-blind study of Atezolizumab (antiPD-L1 antibody) as adjuvant therapy in patients with renal cell carcinoma at high risk of developing metastasis following nephrectomy
IRAS ID
209419
Contact name
Thomas Powles
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-001881-27
Duration of Study in the UK
7 years, 1 months, 1 days
Research summary
Summary of Research
Metastatic renal cell carcinoma (RCC) is the most lethal urologic cancer and the sixth most common cause of cancer deaths in developed nations. Given the evidence of the clinical activity which includes durable response with atezolizumab in advanced and metastatic RCC, atezolizumab offers the potential for clinical benefit in patients with RCC in the adjuvant setting. There is currently no approved, effective adjuvant treatment for RCC following tumour resection, with observation the current standard of care.
The aim of this study is to evaluate the efficacy and safety of atezolizumab versus placebo in patients with RCC, who are at high risk of disease recurrence, following tumor resection.
A total of approximately 664 patients at high risk for RCC recurrence will be recruited into this Phase III, multicenter, randomized, placebo-controlled, double-blind study at approximately 200 centres globally.
Drug treatment of each patient will continue for up to 16 cycles or 1 year, whichever occurs first. Patients will be treated with either atezolizumab (Arm A of the study) or placebo (Arm B of the study).
Surveillance for tumor recurrence will be performed every 3 months ± 2 weeks for 3 years after randomization. After 3 years, patients will undergo tumor assessment every 6 months ± 4 weeks thereafter until disease recurrence per independent central radiologic review, death, consent withdrawal, or study termination by the Sponsor, whichever occurs first. The study will continue for approximately 7 years 4 months from randomization of the first patient to the end of the study.
In the UK it is expected that 19 patients will be enrolled at 6 participating study centres, however recruitment is competitive so this number may increase.
The study is sponsored by F. Hoffman-La Roche Ltd.
Summary of Results
https://forpatients.roche.com/en/trials/cancer/rcc/a-study-of-atezolizumab-as-adjuvant-therapy-in-participants-with.html
REC name
London - Central Research Ethics Committee
REC reference
17/LO/0402
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion