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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Trial Manager
+34 610 28 69 15
trialmanager@sogug.es


Prof Syed Hussain
+44 (0)1142159682
syed.hussain@sheffield.ac.uk


Dr Trial Manager
+34 610 28 69 15
trialmanager@sogug.es


Study Location:

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Be Part of Research - Trial Details - Erdafitinib alone or in combination with cetrelimab as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer whose tumours express FGFR gene alterations and are ineligible for receiving cisplatin treatment
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Erdafitinib alone or in combination with cetrelimab as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer whose tumours express FGFR gene alterations and are ineligible for receiving cisplatin treatment

Recruiting

Open to: All Genders

Age: Mixed

London London Villejuif Madrid Lugo Coruña Barcelona Barcelona Lyon Lyon Paris Toulouse Milan Turin Turin Sheffield London Lancaster Valencia

Medical Conditions

Muscle-invasive bladder cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The primary purpose of this clinical trial is to evaluate the safety and efficacy of erdafitinib (ERDA; a fibroblast growth factor receptor (FGFR)- inhibitor) alone or in combination with cetrelimab (CET; an anti-PD-1 monoclonal antibody) as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations. ERDA is an experimental drug in this clinical trial and is being studied as a potential new treatment in the neoadjuvant setting of patients with non-MIBC which carry specific alterations in the FGFR family. CET is an anti-PD-1 monoclonal antibody (an immune checkpoint inhibitor (ICI)) being studied in the treatment of several tumours, including bladder cancer. A combination of CET plus ERDA seems an interesting approach in FGFR-mutated bladder cancer due to different mechanisms of action and non-overlapping toxicities, as shown in a phase II study in metastatic UC. The SOGUG Group (Sponsor) is a non-profit scientific association whose aim is to promote and develop specific programmes of study and research in the field of genito-urinary tumours.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2024 31 Dec 2026

The number of patients planned in this study is 90, with 45 in each cohort. There will be 21 study sites in 4 countries that will participate in the main study. Treatment will be assigned through a centralized allocation by order of arrival.

In the ERDA group, the patient will receive Erdafitinib (ERDA) in monotherapy neoadjuvant treatment with erdafitinib alone (cohort 1: Erdafitinib) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment)

In the erdafitinib (ERDA) and cetrelimab (CET) group, patients will receive treatment neoadjuvant with erdafitinib alone (cohort 2: Erdafitinib + Cetrelimab) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment).

When the treatment period ends, the patient will have an end-of-trial visit and an imaging and laboratory test before proceeding to surgery. The overall study duration is 60 months.


Patients aged over 18 years old with metastatic bladder cancer

You can take part if:



You may not be able to take part if:


1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer2. Has tumour with any neuroendocrine or small cell component3. Patients who are not considered fit for cystectomy or reject cystectomy4. Prior FGFR-targeted or antiPD1/PDL1 systemic therapy5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Foundation Trust
    Fulham Road
    London
    SW3 6JJ
  • Charing Cross Hospital
    Fulham Palace Road
    London
    W6 8RF
  • Institut Gustave Roussy
    114 Rue Edouard Vaillant
    Villejuif
    94805
  • Hospital Universitario 12 De Octubre
    Av. Córdoba s/n
    Madrid
    28041
  • Hospital Universitario Lucus Augusti
    C/ Dr. Ulises Romero 1
    Lugo
    27003
  • Complexo Hospitalario Universitario A Coruña
    C/ Xubias de Arriba, 84
    Coruña
    15006
  • Hospital Clínic De Barcelona
    C/ de Villarroel, 170
    Barcelona
    08036
  • Hospital De Sabadell (Parc Taulí)
    Parc Taulí, 1 Edifici Parc Taulí, Planta 2, Oncologia
    Barcelona
    08208
  • CLCC Jean Perrin
    Division de Recherche Clinique 58, rue Montalembert
    Lyon
    63011
  • CLCC Léon Bérard
    28 rue Laennec
    Lyon
    69008
  • Institut Mutualiste Montsouris
    42 Bd Jourdan
    Paris
    75014
  • IUCT
    1 avenue Irène Joliot-Curie. Cedex 9
    Toulouse
    31059
  • IRCCS San Raffaele Hospital and Scientific Institute
    Via Olgettina 60. Block B, 5th Floor, Linea Arianna
    Milan
    20132
  • A.O. Ordine Mauriziano, Ospedale Umberto I
    Via Magellano, 1
    Turin
    10128
  • Ospedale Molinette
    Corso Bramante, 88
    Turin
    10126
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Room 228, 2nd Floor Broomcross Building Weston Park Hospital
    Sheffield
    S10 2SJ
  • Barts Health NHS Trust
    Charterhouse Square
    London
    EC1M 5PZ
  • Hospitals of Morecambe Bay NHS Foundation Trust
    Royal Lancaster Infirmary
    Lancaster
    LA1 4RP
  • Instituto Valenciano De Oncología
    Carrer Gregorio Gea 31. Piso 1
    Valencia
    46009

To protect the patient’s safety, the study doctor will evaluate medical records, and perform physical examinations and laboratory studies to decide if the patient can participate in the clinical trial. As with all medicines, the drugs that will be used in this study may cause side effects, although not everyone will experience them. During the study, patients will be carefully monitored to detect the possible onset of these effects.
1. Erdafitinib: Very Common (occurring in ≥10% of patients)
Higher than normal levels of phosphate in the blood; dryness of the mouth; ulcers, blisters or pain in the mouth including cheeks, tongue, or lips; diarrhoea; nail changes and disorders, including the nails, separation from the nail bed, nail pain, nail bleeding, breaking of the nails, colour or texture changes in your nails; skin problems including dryness and cracking; skin reactions with peeling, redness, swelling tingling or pain in palms of the hands and soles of the feet, called hand-foot syndrome; dryness of eyes; redness and irritation of the eye, may be associated with increased tearing of the eyes, itchy eyes, inflamed eyes; loss of hair; decreased appetite; taste disorder with food tasting sour, bitter or metallic.
Eye disorders pertaining to fluid build-up under the retina (the light-sensitive layer at the back of the eye) that may or may not be associated with visual symptoms such as blurred or diminished vision or loss of vision; infected skin around the nail; itching; dryness of the nose.

Less Common (occurring in < 1% subjects); A condition caused by calcium deposits in blood vessels, that can lead to painful red skin lesions, that may sometimes lead to open wounds, and the open wounds could become infected; skin lumps that may be skin coloured or white, soft or hard, and can become painful.
Very Common (affects more than 1 user in 10):
Physical weakness and loss of strength; feeling tired or weak; shortness of breath; cough; diarrhoea (watery, loose, or soft stools); nausea; vomiting; decreased appetite; fever; pain in specific regions such as in the muscles, and bones, back, stomach, or joints; skin rash, dry skin or redness, itching; increase in liver enzymes in the blood; changes in blood levels of electrolytes (such as sodium or potassium), enzymes (such as amylase or lipase) or metabolites (such as creatinine); allergic reaction or reaction to the medicine infusion which may cause fever, chills, rash.
Infrequent bowel movements (constipation); changes in blood pressure (hypertension or hypotension); headache; swelling in extremities (edema); underactive thyroid gland, which can cause tiredness or weight gain, overactive thyroid gland, which can cause rapid heart rate, sweating, weight loss; high sugar levels in the blood (hyperglycemia); difficult sleeping or falling asleep (insomnia); decreased number of platelets or white blood cells; rapid heart rate (tachycardia); urinary tract infection; dizziness; nervous behaviour (anxiety); inflammation of the intestines (gastroenteritis or colitis) or stomach (gastritis) characterized by vomiting, stomach pain, constipation, dry mouth, bloody stools; dry mouth, mouth ulcers and cold sores (stomatitis); change in taste (dysgeusia); difficulty swallowing (dysphagia); indigestion (dyspepsia); blockage of the small or large bowel (intestinal obstruction); changes in weight; infections of the upper respiratory tract including bronchitis; serious lung infection (pneumonia); coughing up blood (haemoptysis); build-up of fluid in the tissues surrounding the lungs, chest cavity or abdomen (pleural effusion or ascites); inflammation of the lungs (pneumonitis), characterized by coughing and difficulty breathing, shortness of breath, chest pain; inflammation of the kidney, kidney failure, blood in urine.
The patient may experience some, none or all of these side effects and they may be mild, moderate or severe. Many of these side effects may disappear when the treatment is discontinued. In addition, there is always a risk of a very rare or previously unknown side effect occurring. The study doctor will inform the patient of any new data that may become available during the course of the study regarding the safety of the treatment.

Dr Trial Manager
+34 610 28 69 15
trialmanager@sogug.es


Dr Trial Manager
+34 610 28 69 15
trialmanager@sogug.es


Prof Syed Hussain
+44 (0)1142159682
syed.hussain@sheffield.ac.uk



The study is sponsored by Spanish Oncology Genitourinary Group and funded by Janssen.



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Read full details for Trial ID: ISRCTN14498712

Or CPMS 55028

Last updated 28 August 2024

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