INVEST
Research type
Research Study
Full title
INVEST: Phase I study of Intravesical immunotherapy for bladder cancer patients undergoing radical cystectomy
IRAS ID
1004693
Contact name
Jamie Oughton
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2021-006537-19
ISRCTN Number
ISRCTN15842444
Research summary
Bladder cancer is a common disease that can be difficult to manage. For some, it can be treated using medicines given into the bladder, whilst others need removal of their entire bladder.
In INVEST, we are investigating a drug called atezolizumab that could be used to control bladder cancer. The long-term hope is that the results from INVEST will reduce the need for bladder removal in the future. This is an immunotherapy treatment (a type of treatment that helps your immune system fight cancer), usually given directly into the blood stream via a vein (intravenously). We are investigating whether atezolizumab can be safely given directly into the bladder, and whether there is any suggestion it may work on the cancer and immune system.
We are investigating giving atezolizumab directly into the bladder via two routes. These are introducing it directly into the bladder using a catheter (passive instillation) and injecting it directly into the tumour within the bladder (direct injection). We are also exploring which dose to use (600mg or 1200mg), and how many doses (single dose, or multiple doses: weekly for 3-6 weeks).
We will give the drug to a small number of participants (between 6-62 in total) planned to have bladder removal surgery (cystectomy) as a treatment for their bladder cancer. This means we can find the best dose, check for side effects, and explore how the drug works on the cancer. A larger trial will be required to fully test the performance of the drug.
Study treatment will take place between diagnosis of bladder cancer and cystectomy. Participants will be followed up after surgery for three months, and we will collect data on participants’ overall health status at the end of the study (2 years after registration of the final participant).REC name
London - Central Research Ethics Committee
REC reference
22/LO/0651
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion