CA209-7G8 Nivolumab & BCG vs SOC in non muscle invasive Bladder Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination with Intravesical BCG versus Standard of Care BCG Alone in Participants with High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment with BCG
IRAS ID
273896
Contact name
Robert Jones
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-002567-96
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1235-2749, UTN
Duration of Study in the UK
11 years, 3 months, 17 days
Research summary
This is a multicentre, phase 3 study of the investigational drug nivolumab combined with intravesical BCG compared to the standard treatment of BCG alone in patients with high-risk, non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG.
Nivolumab is a type of immunotherapy drug that is designed to stimulate the body's own immune system to help attack cancer cells. This study will assess if nivolumab combined with BCG delays disease worsening (disease progression) or disease returning (disease recurrence) in non-muscle invasive bladder cancer.
700 patients will take part globally in this study, 40 of them in the UK.
This is a double blind study, so patients and doctors will not know what treatment patients will receive. Following a screening period, eligible patients will be randomly assigned to either receive BCG combined with nivolumab, or BCG with nivolumab matching placebo.
Patients will receive nivolumab or nivolumab placebo (dummy drug) through a vein every 4 weeks, during a hospital visit. BCG will be given every week for 6 weeks at the beginning of the study treatment, then every week for 3 weeks at months 3, 6, 12, 18, 24, 30 and 36.
Throughout the study, patients will have the following procedures: bladder biopsies, cystoscopies, CT/MRI scans, physical exams, ECGs, vital signs (blood pressure, heart rate and temperature), blood sampling and for women, pregnancy testing. They will also have to complete questionnaires regularly. They will have follow-up visits after the end of their treatment.
Patients will receive nivolumab or nivolumab placebo for up 2 years and BCG for 3 years or until they withdraw their consent to receive the study drugs, or they no longer tolerate the study treatment or their cancer progresses.
The study is paid by Bristol-Myers Squibb (BMS).
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0057
Date of REC Opinion
9 Mar 2020
REC opinion
Further Information Favourable Opinion