CA209-914 Nivolumab in Patients with Renal Cell Carcinoma
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
IRAS ID
227566
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corportation
Eudract number
2016-004502-34
Duration of Study in the UK
9 years, 3 months, 26 days
Research summary
This study is a multi-centre phase 3 study involving investigational drugs nivolumab and ipilimumab in patients 18 years or older who have a type of kidney cancer that was removed by surgery (partial or complete nephrectomy ie. removal of some or all of the kidney) and are at moderate/high risk of the tumor coming back (disease relapse). Approximately 800 patients will be treated in the study globally, with approximately 50 patients in the UK. The study is sponsored by Bristol-Myers Squibb.
Renal cell cancer is the eighth most common cancer in the world with the incidence increasing. Despite the early detection and surgical removal of small kidney tumors, death rate due to this cancer is increasing, suggesting the need to improve early management of this disease. The purpose of this study is to find out if treatment with a combination of nivolumab plus ipilimumab, given as adjuvant therapy (after surgery), will improve the outcomes of patients who have had a partial or full nephrectomy and are at risk of relapse. To understand if this drug combination improves patients’ outcome, half the patients will receive a dummy drug (placebo) and half will receive the study drug combination. The study treatment allocation is blinded, so neither the patient nor study doctor will know which treatment will be given.
Nivolumab and ipilimumab are types of immunotherapy treatments which work by helping the body's own immune system to attack the cancer cells.
Following a screening period, eligible patients will receive either nivolumab plus ipilimumab combination or placebo, for a maximum of 24 weeks. Patients will be followed until disease progression. All treatments will be given intravenously (through the vein) every 2 weeks.
Patients will undergo the following procedures during the study: biopsy, CT/MRI scan, physical examinations, blood sampling for safety, drug levels and biomarkers.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0439
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion