Durvalumab in combination with BCG in NMIBC

• Research type

  Research Study

• Full title

  A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG-Naïve Non-Muscle-Invasive Bladder Cancer Patients (POTOMAC)

• IRAS ID

  236593

• Contact name

  Hugh Mostafid

• Contact email

  hugh.mostafid@nhs.net

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2017-002979-26

• Duration of Study in the UK

  6 years, 1 months, 15 days

• Research summary

  This study is being conducted to compare a potential new treatment for patients who have non-muscle invasive bladder cancer (NMIBC). This study will aim to determine how safe and effective the new treatment, durvalumab in combination with BCG, is in treating patients with NMIBC in comparison with BCG alone. Durvalumab is an antibody (a protein produced by the body’s defence system), which hopefully will help the immune cells to prevent /slow down cancer growth.

  This study will include about 975 patients globally and will be conducted at sites with expertise in the treatment of NMIBC. In order to take part, patients must be aged 18 years or older and have high-risk tumour(s). Patients must have tissue sample available from their recent surgery or previously collected tissue within the last 3 years before study entry.

  Patients will be randomly assigned to one of the three treatment groups:

  - Durvalumab + BCG (induction and maintenance)
  - Durvalumab + BCG (induction only)
  - BCG (induction and maintenance) alone

  Durvalumab is given into a vein for approximately an hour and the BCG is given into the bladder through a catheter.

  Patients will visit the clinic weekly for the first 6 weeks (induction) and then once a week for 3 weeks at months 3, 6, 12, 18 and 24 (maintenance) to receive BCG. Patient who are assigned to receive durvalumab will receive treatment once every 4 weeks until month 12. At each visit, patients will undergo various tests such as physical exam and laboratory tests. Imaging and/or urine test will be done every 3 months to monitor patient’s tumour.

  When a patient stops study treatment and the associated intensive monitoring ends, they will remain in the study for long term follow up of their disease outcomes.

  The study is anticipated to continue until August 2024.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  18/EM/0148

• Date of REC Opinion

  16 Jul 2018

• REC opinion

  Further Information Favourable Opinion