CA209-274 Adjuvant Nivolumab versus Placebo in Urothelial Cancer
Research type
Research Study
Full title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma
IRAS ID
194253
Contact name
Robert Huddart
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-003626-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 3 months, 20 days
Research summary
Invasive urothelial carcinomas (IUC) in renal pelvis or ureter are managed with radical resection, while standard of care for muscle invasive bladder cancer is radical cystectomy, preceded by cisplatin treatment, called neo-adjuvant therapy. Patients with invasive disease at radical resection of IUC are at high risk of recurrence. If neo-adjuvant cisplatin was not administered, patients may receive adjuvant cisplatin post-surgery, which, however, has not shown definitive clinical benefit. Moreover, up to 60% of patients who undergo radical cystectomy are not candidates for adjuvant cisplatin therapy because they already received it prior to the surgery or are not fit to receive cisplatin at all. This population has significant unmet need as there are no treatment options available to help reduce the risk of recurrence and improve survival. The goal of this trial is to assess whether prophylactic immunotherapy after a complete resection prevents recurrence. The effectiveness of an immune therapy agent called nivolumab, which works by blocking a protein on the body’s immune cells, called PD-1, so that tumours can be recognised as foreign and attacked by the immune system, will be compared with placebo. Nivolumab is already marketed in the UK for the treatment of unresectable or metastatic melanoma (a skin cancer) and locally advanced or metastatic squamous non small cell lung cancer after prior chemotherapy. Patients will be randomised to nivolumab or placebo arms depending on their PD-L1, lymph node and previous cisplatin neo-adjuvant chemotherapy status. Patients will receive 240 mg nivolumab or placebo every 2 weeks for up to one year or until recurrence, whichever occurs first, and will then enter a follow-up phase. Patients will undergo the following procedures during the study: CT/MRI scans, physical exams, blood sampling for safety and research testing. Patients will be treated by oncology teams in specialised NHS clinics. 640 patients will be treated in the study with approximately 20 being treated in the UK. The study is sponsored by Bristol-Myers Squibb.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0048
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion