A trial looking at erdafitinib and cetrelimab for bladder cancer (SOGUG-NEOWIN) (2024)

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.

One of the main treatments for muscle invasive bladder cancer is surgery. We know from research that having a course of chemotherapy before surgery works better than surgery on its own. The chemotherapy includes a cancer drug calledcisplatin. 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 called a cancer growth blocker. It works by blocking a growth receptor 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 called an immunotherapy. It works by stimulating the immune system 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

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 vagin* (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 in the pelvis
• have cancer that has spread to other parts of the body
• have bladder cancer that is part neuroendocrine 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 ). You can join if you had BCG 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 , in situ carcinoma 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 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 . 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
• have an active autoimmune disease 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 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

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 ). 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 ) 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.

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

• a physical examination
• blood tests
• heart trace (ECG)
• a CT scan, MRI scan or PET-CT scan. Your doctor will tell you which scan you have.

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

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.

The most common side effects of cetrelimab include:

• weakness and loss of strength
• feeling tired (fatigue)
• shortness of breath
• cough
• diarrhoea or constipation
• feeling or being sick
• loss of appetite
• high temperature (fever)
• pain in the muscles, back, bones, stomach or joints
• skin rash
• dry, red or itchy skin
• changes to how your liver works
• changes to the level of substances in your blood such as minerals and enzymes
• an allergic reaction or reaction to the infusion which may cause a fever, chills and a rash

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.

Lancaster

London

Sheffield