A trial looking at erdafitinib and cetrelimab for bladder cancer (SOGUG-NEOWIN)

Cancer type:

Bladder cancer

Status:

Open

Phase:

Phase 2

This trial is looking at erdafitinib on its own or in combination with cetrelimab for bladder cancer that has spread into or through the muscle layer of the bladder. This is called muscle invasive bladder cancer.

It is open to people with muscle invasive bladder cancer that are not able to or do not want to have cisplatin. 

You pronounce erdafitinib as eer-da-fit-i-nib.

You pronounce cetrelimab as set-re-li-mab.

More about this trial

One of the main treatments for muscle invasive bladder cancer is surgery. We know from research that having a course of chemotherapy Open a glossary item before surgery works better than surgery on its own. The chemotherapy includes a cancer drug called cisplatin. But some people cannot have cisplatin. And researchers are looking for other treatments that people in this situation can have. In this trial they are looking at the drugs erdafitinib and cetrelimab. 

Erdafitinib is a targeted drug Open a glossary item called a cancer growth blocker. It works by blocking a growth receptor Open a glossary item on cancer cells. Blocking this receptor stops a signal that tells the cancer cells to grow. Doctors already use erdafitinib for other cancers that have spread. 

Cetrelimab is a monoclonal antibody Open a glossary item called an immunotherapy. It works by stimulating the immune system Open a glossary item to find and kill cancer cells.

In this trial you have either:

  • erdafitinib on its own or
  • erdafitinib with cetrelimab

The aims of this trial are to find out:

  • how well erdafitinib works on its own 
  • how well the combination of erdafitinib and cetrelimab works
  • more about the side effects of these treatments
  • whether these treatments delay surgery

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

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

  • have bladder cancer that has spread into or through the muscle of the bladder but no further than the prostate, womb or vagina (stage T2 to T4a). And at least half or more of the cancer is a type called urothelial bladder cancer. Your doctor will know about this.
  • had a trans urethral removal of bladder tumour (TURBT) to diagnose your cancer no later than 3 months before having tests to see if you can join the trial
  • have cancer cells that have particular changes in the fibroblast growth factor receptor (FGFR). Your doctor will know if your cancer cells have this.
  • are not able to have cisplatin or you do not want cisplatin
  • have satisfactory blood test results
  • are up and about but might not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use reliable contraception during the trial treatment and for a certain period of time after stopping trial treatment
  • are at least 18 years old

Who can’t take part

Cancer related

You cannot join this trial if any of these apply. You:

  • have cancer that has spread to more than 1 lymph node Open a glossary item in the pelvis Open a glossary item
  • have cancer that has spread to other parts of the body
  • have bladder cancer that is part neuroendocrine Open a glossary item or that contains small cell bladder cancer. Your doctor will know this.
  • have had muscle invasive bladder cancer before
  • have urothelial cancer that is in other parts of the urinary system than the bladder such as the kidneys, ureters and urethra. Your doctor will know this.
  • are not able to have your bladder removed by surgery (cystectomy) or you do not want to have a cystectomy
  • have had previous treatment for bladder cancer. This does not include having trans urethral removal of bladder tumour (TURBT) or taking tissue samples (biopsies Open a glossary item). You can join if you had BCG Open a glossary item or other treatment into the bladder for non muscle invasive bladder cancer as long as treatment was completed at least 6 weeks ago.
  • have had medication that targets FGFR or targets the PD1 or PD-L1 receptors. Your doctor will know this.
  • have had another cancer in the past 3 years. This is apart from non melanoma skin cancer Open a glossary item, in situ carcinoma Open a glossary item of the cervix and prostate cancer that is completely in the prostate gland and has a low risk of getting worse.

Medical conditions

You can’t take part if any of the following apply. You:

  • have major surgery within 14 days of starting treatment or you are still recovering from surgery
  • have a severe infection or you have an ongoing infection
  • have adrenal glands Open a glossary item that are not working well and this is not controlled
  • have hepatitis B or hepatitis C. The doctor does a blood test to find this out.
  • have HIV or AIDS
  • have certain heart problems Open a glossary item. Your doctor will ask about this.
  • have inflammation of the lungs (pneumonitis) not caused by an infection or you had pneumonitis and this was treated with steroids Open a glossary item
  • have an active autoimmune disease Open a glossary item that needed treatment in the past 2 years with treatment that reaches the whole body (systemic treatment) such as steroids. This is apart from medication that replaces what the body would have produced such as insulin for diabetes and thyroxine because your thyroid isn’t working well.
  • have an immune system Open a glossary item that isn't working well
  • are taking medication that damps down your immune system within 14 days of starting trial treatment. This is apart from a small dose of steroids. Your doctor will know the dose.
  • are not able to swallow or keep down capsules and tablets
  • have or had problems with the amount of calcium and phosphate in your body. Or you have a problem with the amount of minerals in your body. Your doctor will know about this.
  • have a condition affecting the retina of your eye called central serous retinopathy (CSR) or a problem called retinal pigment epithelial detachment (RPED)
  • have any other medical conditions or mental health problems that could affect you taking part

Other

You can’t take part if either of following apply. You:

  • are allergic or sensitive to any of the drugs used in this trial, any of their ingredients or any similar drugs
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 90 people in Europe to take part including 25 people in the UK.

There are 2 groups in this trial. Your doctor will discuss with you which group you go into. The 2 groups are:

  • erdafitinib on its own
  • erdafitinib in combination with cetrelimab

Erdafitinib is a tablet. You take it once every 3 weeks for 9 to 12 weeks before your planned surgery. Your doctor will tell you how many tablets you take. 

You have cetrelimab as a drip into a vein. You have it once every 3 weeks for 9 to 12 weeks before your planned surgery.  

You have a diary to record when and how many erdafitinib tablets you take. You must bring this in with you when you go to the hospital. 

Quality of life

You fill in a questionnaire:

  • before starting the trial treatment
  • when you finish the trial treatment
  • 8 to 12 weeks after surgery

The questions ask about:

  • your general health and wellbeing
  • your daily activities
  • any side effects

This is called a quality of life questionnaire. 

Samples for research
The team take blood samples while you are on treatment. Where possible they will take these when you have blood tests as part of your routine care.

They will ask for some extra blood samples, urine and poo (faeces) samples. They will ask for a small piece of tissue from tissue samples (biopsies Open a glossary item). One is from the biopsy when you were first diagnosed. The other is from the tissue removed when you have your surgery. They will use these samples to look for substances (biomarkers Open a glossary item) that could tell them who might benefit from having erdafitinib and cetrelimab.

You don’t have to have these extra samples taken. You can still take part in the trial.

PET-MRI sub study

The team will ask people who are having their treatment in Sheffield to take part in this sub study. You go to the University of Sheffield to have 2 PET-MRI scans. You have a scan when you:

  • agree to join the trial
  • have finished the trial treatment and before you have surgery

You don’t have to agree to take part in the sub study. You can still take part in the trial. 

Hospital visits

You see the doctor to have tests before taking part in the trial. These tests include:

You see the doctor regularly when having treatment. This is to see how you are and for blood tests.
 
You see the doctor between 8 and 12 weeks after your surgery. This is for:

  • a physical examination
  • blood tests
  • a scan

Follow up

You see the doctor about every 12 weeks. This is:

  • to see how you are
  • for a physical examination
  • for a scan

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Cetrelimab can affect the immune system Open a glossary item. This may cause inflammation  Open a glossary itemand other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

The most common side effects of cetrelimab include:

The most common side effects of erdafitinib include:

  • high levels of phosphate in the blood
  • mouth problems such as dryness, ulcers, blisters and pain
  • diarrhoea
  • nail changes such as pain, bleeding, breaking, changes in colour and texture and the nail coming away from the nail bed
  • dry, cracked skin
  • peeling of skin, redness, pain, swelling or tingling of the palms of the hand, soles of feet or both. This is called hand foot syndrome.
  • eye problems such as dry, red, itchy and watery eyes
  • loss of hair
  • loss of appetite and changes to taste

We have information about problems after bladder surgery. 

Location

Lancaster
London
Sheffield

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.

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Questions to ask your doctor about clinical trials
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

Janssen
Spanish Oncology Genitourinary Group 
University of Sheffield

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19122

Print page
Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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