A trial of chemotherapy and nintedanib for people with invasive bladder cancer (NEOBLADE)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Open

Phase:

Phase 2

This trial is looking at 2 chemotherapy drugs called gemcitabine and cisplatin alongside a new drug called nintedanib for invasive bladder cancer. It is for people who have the most common type of bladder cancer called transitional cell cancer.

If bladder cancer has grown into the muscle layer of the bladder, it is called invasive bladder cancer. Doctors can treat invasive bladder cancer with chemotherapy before surgery to remove the bladder. Or you may have chemotherapy before radiotherapy or a combination of radiotherapy and chemotherapy (chemoradiotherapy).

Having chemotherapy before surgery or radiotherapy can help these treatments to work better. Doctors often use a combination of the chemotherapy drugs gemcitabine and cisplatin. But researchers are looking at ways to improve treatment. In this trial they are looking at a drug called nintedanib alongside gemcitabine and cisplatin.

Nintedanib (also known as BIBF 1120) is a type of biological therapy. It stops the signals that cancer cells use to grow. Some people taking part in the trial have gemcitabine and cisplatin, some have gemcitabine, cisplatin and nintedanib.

The aims of the trial are to find out

  • Which drug combination works best for invasive bladder cancer
  • The best dose of nintedanib for people whose kidneys aren’t working well
  • More about the side effects

Who can enter

You may be able to join this trial if all of the following apply

  • You have transitional cell bladder cancer that has grown into the muscle layer of the bladder or beyond (stage T2 to T4a) but has not spread into your lymph nodes or to anywhere else in your body
  • You can have gemcitabine and cisplatin
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Your kidneys are working well (a small group of people whose kidneys aren’t working well may be able to take part. The trial team can tell you more about this)
  • You have satisfactory blood test results
  • You are at least 18 years old
  • You are willing to use reliable contraception during the trial and for up to 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply

  • You have any other cancer which means you can’t have the treatment in this trial (the trial team can tell you more about this)
  • You have any other medical condition that the trial team think could affect your taking part
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 120 people to join.

It is a randomised trial. The people taking part will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

  • People in one group have gemcitabine, cisplatin and nintedanib
  • People in the other group have gemcitabine, cisplatin and a dummy drug (placebo)

NEOBLADE trial diagram

You have treatment in 3 week periods called cycles of treatment. You have gemcitabine and cisplatin through a drip into a vein. In each cycle of treatment, you have gemcitabine twice and cisplatin once. Nintedanib and the dummy drug are capsules that you take twice a day everyday.

You have 4 cycles of treatment. When you finish treatment, your doctor will talk to you about further treatment options. You then go on to have 1 of 3 usual treatments that people have after chemotherapy for invasive bladder cancer. These include

The researchers will ask for a sample of your cancer that was removed when you had a biopsy. You will have another biopsy during your 3rd cycle of treatment and 3 months after treatment finishes if you don’t go on have surgery.

A small study called a sub study will run alongside the main trial. This will include 12 people with invasive bladder cancer whose kidneys aren’t working well.

The first 3 patients will have a low dose of nintedanib. If they don’t have any serious side effects, the next 3 patients will have a higher dose. If they do have any serious side effects, the next 3 patients will have a lower dose. And so on, until they find the best dose to give. This is called a dose escalation study. If the researchers find a safe dose for people whose kidneys don’t work well, they may be able to take part in the main trial. Everyone will have gemcitabine and cisplatin alongside nintedanib. Patients on the sub study will also have ‘split dose’ cisplatin, which means that the total cisplatin dose given in each treatment cycle is split across two visits, rather than giving it to the patient all at once.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • A physical examination
  • Blood tests
  • A heart trace (ECG)
  • CT Scan
  • Urine tests

You go to the hospital twice in each 3 week cycle to have your chemotherapy. You have regular blood tests and urine tests. You have a CT scan during your 3rd cycle of treatment.

You see the trial team for a check up 3 months after surgery or when you finish radiotherapy or chemoradiotherapy. You have another CT scan 6 months later. After that you have a CT scan and see the trial team for a check up once a year for up to 5 years.

Side effects

The most common side effects of nintedanib include

The most common side effects of gemcitabine include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Feeling or being sick
  • Skin rash or itching
  • Changes to the way your liver works
  • Hair loss
  • Small amounts of blood and protein in your urine
  • High temperature (fever) and chills
  • Swelling in your arms and legs due to a fluid build up

The most common side effects of cisplatin include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Kidney problems
  • High temperature and chills

We have more information about

 

Location

Birmingham
Cardiff
Coventry
Glasgow
Lancaster
Leeds
Liverpool
London
Manchester
Preston
Southampton
Sutton
Wirral

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr 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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11977

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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