A trial of chemotherapy and nintedanib for people with invasive bladder cancer (NEOBLADE)
Cancer type:
Status:
Phase:
This trial looked at gemcitabine and cisplatin alongside nintedanib for invasive bladder cancer.
This trial was open for people to join between 2014 and 2018. The team published the results in 2022.
More about this trial
Bladder cancer that has grown into the muscle layer of the bladder is called invasive bladder cancer.
When this trial was done, the usual treatments for invasive bladder cancer included chemotherapy:
- before surgery to remove the bladder
- before radiotherapy
- with radiotherapy (
chemoradiotherapy 
)
Having chemotherapy before these treatments can help them to work better. The chemotherapy drugs often used were gemcitabine and cisplatin.
In this trial, they looked at whether having nintedanib alongside gemcitabine and cisplatin makes chemotherapy work better. Nintedanib is a type of targeted cancer drug. It stops the signals that cancer cells use to grow.
This was a phase 2 trial. A computer put people taking part into one of 2 groups at random. Neither they nor their doctor could decide which group they were in. And neither of them knew which group they were in. This is called a double blind trial:
- half had gemcitabine, cisplatin and nintedanib
- half had gemcitabine, cisplatin and a dummy drug (
placebo )
The main aims of the trial were to find out:
- which treatment works best for invasive bladder cancer
- more about the side effects
Summary of results
This trial showed that having nintedanib alongside gemcitabine and cisplatin didn’t help stop invasive bladder cancer growing.
Results
A total of 120 people joined the trial. They were put into 1 of 2 groups at random:
There were:
- 57 people in the gemcitabine, cisplatin and nintedanib group
- 63 people in the gemcitabine, cisplatin and a dummy drug (placebo) group
People taking part had 4 in total. Each cycle lasted 3 weeks.
The researchers were able to analyse the results for most people who took part.
They looked at how many people had no signs of cancer on a scan. They found it was:
- 21 out of 57 people (37%) in the group who had nintedanib
- 20 out of 63 people (32%) in the group who had the placebo
They also looked at the number of people whose bladder cancer didn’t start to grow and who were still living 5 years after they joined the trial. They found it was:
- 39 out of 57 people (68%) in the nintedanib group
- 33 out of 63 people (52%) in the placebo group
The researchers looked at the number of people who were living, 5 years after they joined the trial. They found it was:
- 34 out of 57 people (60%) in the nintedanib group
- 31 out of 63 people (49%) in the placebo group
Side effects
Everyone in the nintedanib group and almost everyone (95%) in the placebo group had at least one side effect from treatment. But many were mild and didn’t last long.
The most common side effects were:
- tiredness (fatigue)
- feeling sick (nausea)
- constipation or diarrhoea
Some people had more severe side effects. This was:
- 41 people (72%) in the nintedanib group
- 38 people (60%) in the placebo group
The most common of the more severe side effects were:
- blood clots
- a drop in white blood cells (
neutrophils ) - high blood pressure
Some people decided to stop treatment because of the side effects they were having. This was:
- 28 people (49%) in the nintedanib group
- 13 people (21%) in the placebo group
We have more information about the side effects of gemcitabine, cisplatin and nintedanib in our Cancer drugs section.
Conclusion
The trial team concluded that having nintedanib with gemcitabine and cisplatin did not work better for invasive bladder cancer.
Sometimes trials show a different treatment isn’t useful for a particular type or of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.
More detailed information
There is more information about this research in the reference below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Addition of nintedanib or placebo to neoadjuvant gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer (NEOBLADE): a double-blind, randomised, phase 2 trial
S Hussain and others
The Lancet Oncology, 2022. Volume 23, issue 5, pages 650-658.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists () and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Syed Hussain
Supported by
Boehringer Ingelheim
Clatterbridge Cancer Centre NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Liverpool
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
