CA209-9UT Nivolumab or Nivolumab/BMS-986205 alone or with BCG in NMIBC
Research type
Research Study
Full title
A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
IRAS ID
242065
Contact name
Simon Crabb
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-003581-27
Clinicaltrials.gov Identifier
U1111-1201-4325, UTRN
Duration of Study in the UK
4 years, 8 months, 26 days
Research summary
This is a multicentre, phase 2 study of the investigational drug nivolumab, given alone or in combination with another investigational drug called BMS-986205, combined with intravesical BCG in patients with high-risk, non-muscle invasive bladder cancer, unresponsive to BCG treatment.
Nivolumab is a type of immunotherapy drug that is designed to stimulate the body’s own immune system to help attack cancer cells. BMS-986205 may make cancer cells more sensitive to an attack by the immune system.
This study will assess if nivolumab or nivolumab/BMS-986205 alone or combined with BCG gives complete responses and delays the progression in non-muscle invasive bladder cancer.
480 patients will take part globally in this study, 50 of them in the UK.
This is an open-label study, so patients and doctors will know what treatment patients will receive. Following a screening period, eligible patients will be randomly assigned to either receive nivolumab, nivolumab/BMS-986205 alone or combined with BCG.
Patients will take a dose of BMS-986205 as a pill every day after a meal at home, and will receive nivolumab through a vein every 4 weeks, during a hospital visit. BCG will be given every 6 weeks as induction therapy, and for 3 weeks at 3, 6 and 12 months.
Throughout the study, patients will have the following procedures: up to 4 bladder biopsies, cystoscopies, CT/MRI scans, physical exams, ECGs, vital signs, oxygen saturation, blood sampling and for women pregnancy testing. They will also have to complete questionnaires regularly and, every day during their treatment, a pill diary. They will have follow-up visits after the end of their treatment.
Patients will receive the drugs for up to 1 year 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
London - Chelsea Research Ethics Committee
REC reference
18/LO/0963
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion