CA017-078: Nivolumab and BMS-986205 in Participants with MIBC
Research type
Research Study
Full title
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer.
IRAS ID
257127
Contact name
Deborah Enting
Contact email
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2017-004692-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1206-8521, WHO UTN
Duration of Study in the UK
7 years, 6 months, 26 days
Research summary
This is a multicentre, phase 3 study in patients with a type of cancer called muscle invasive bladder cancer (MIBC for short). This study will look to see if treatment with nivolumab + BMS-986205 + standard chemotherapy given before surgery followed by maintenance nivolumab/BMS-986205 treatment after surgery will significantly improve response (to treatment) and survival rate (without complications) when compared to standard chemotherapy alone.
954 patients will take part globally in this study with 36 in the UK.
Patients will be randomly assigned to 12 weeks of pre-surgery treatment:
• Arm A - chemotherapy alone
• Arm B - nivolumab +BMS-986205 placebo + chemotherapy
• Arm C - nivolumab + BMS-986205 + chemotherapy
All patients will be on standard chemotherapy before surgery so this part of the treatment is open-label (meaning we know what you are taking). However, 2 of the 3 arms will have blinded BMS-986205. This means that you and the study doctor will not know if you are taking the real BMS-986205 or a placebo. Chemotherapy and Nivolumab are given every 3 weeks through a vein and the BMS-986205/placebo taken as a tablet (daily) during the pre-surgery phase.
After surgery, patients on arms B and C will go onto maintenance treatment (as described before) for 36 weeks. BMS-986205 is taken daily and nivolumab is given every 4 weeks.
Patients will have the following procedures: bladder surgery (if well enough), at least 1 biopsy (during surgery), cystoscopies, CT/MRI scans, physical exams, ECGs and blood sampling. They will also have to complete questionnaires regularly and a pill diary.
Patients will receive the drugs for just over 1 year or until they withdraw their consent/can no longer tolerate the study treatment/their cancer progresses. They will have follow-up visits after the end of their treatment.
The study is paid by Bristol-Myers Squibb (BMS).REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0253
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion