At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Erdafitinib monotherapy (drug), Cetrelimab and Erdafitinib combination (drug)
- How long the study runs
- Study runs about 79 months (dates as stated)
- About the drug or intervention
- Erdafitinib monotherapy — drug: Patients will receive treatment with erdafitinib alone (cohort 1) · Cetrelimab and Erdafitinib combination — drug: Patients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at erdafitinib, taken on its own or with cetrelimab, in adults with muscle-invasive bladder cancer (cancer that has grown into the muscle wall of the bladder) whose tumours have a change in a gene called FGFR. It is for people who cannot have or do not want cisplatin-based chemotherapy. The study is run by the Spanish Oncology Genito-Urinary Group.
Who can take part
- Adults aged 18 or over
- Diagnosed with muscle-invasive bladder cancer (stage T2-4a) confirmed by tissue testing, with a tumour sample taken within the last 3 months
- Bladder cancer that is mainly (at least half) urothelial type, the most common type of bladder cancer
- Able to carry out normal daily activities with little or no help (performance status 0-1)
- Unable to have or choosing not to have cisplatin-based chemotherapy
- Tumour has a selected FGFR gene change
- Good enough organ function
- No other cancer
- Willing to avoid pregnancy or fathering a child during the study
- Given written informed consent to take part
Who may not be able to
- Cancer that has spread to lymph nodes further away or to other parts of the body
- Tumour contains any neuroendocrine or small cell type
- Not fit enough for surgery to remove the bladder, or does not want that surgery
- Previous treatment with FGFR-targeted drugs or immunotherapy drugs called checkpoint inhibitors
- Any previous drug treatment, radiotherapy or surgery for bladder cancer
What taking part involves
- • Taking erdafitinib on its own or together with cetrelimab — how each person is assigned is not stated — ask the trial team
Time commitment: Visits, duration and what taking part involves are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 90
- Started
- 2023-03-07
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for muscle-invasive bladder cancer
- • Phase2 - 90 participants
- • Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with muscle-invasive bladder cancer
Where?
- • Lancaster - University Hospitals of Morecambe Bay NHS Foundation Trust
- • London - The Royal Marsden NHS Foundation Trust
- • London - Barts Health NHS Trust
- • London - Charing Cross Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.
More detail
The aim of the study is to assess the antitumor activity measured as ypT0 rate, defined as no evidence of residual disease based on pathological review of the surgical specimen (pCR) and tumour downstaging (\<ypT2). Patients must have a MIBC (cT2-T4a N0/N1 M0) who harbour selected FGFR alterations stated in the protocol and are either ineligible for or refuse cisplatin-based neoadjuvant chemotherapy, as defined by consensus criteria (see 6.1 Inclusion criteria). Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form, they will receive erdafitinib alone (cohort 1) or erdafitinib in combination with cetrelimab (cohort 2). Patients will receive neoadjuvant treatment with erdafitinib alone (cohort 1) or erdafitinib plus cetrelimab (cohort 2) before proceeding to Radical Cystectomy (RC) (to be performed within 2 - 6 weeks after the last study drug treatment) Cohort 1: patients will receive erdafitinib Cohort 2: patients will receive erdafitinib in combination with cetrelimab intravenously (IV) Radiological assessment: A Computed Tomography /Magnetic Resonance Imaging and/or Positron Emission Tomography (per standard local imaging practices) will be scheduled as follow: * Basal assessment: during screening period (no more than 28 days before Cycle1, Day 1(C1D1) * Response assessment: At the end of treatment period allowing time for imaging review in advance of Radical cystectomy (RC). * Follow-up assessment: an image evaluation must be done at first follow-up visit and thereafter, it will be schedule according to local standards and as clinically indicated. A local pathological assessment will be done on specimens obtained during RC (for co-primary endpoints). Thereafter, during the follow-up period, pathological assessments will be scheduled according to local standards and as clinically indicated. Patients with disease progression during the treatment phase will be discontinued from the study and will receive their treatment according to the investigator's judgment and monitored to evaluate Overal Survival .
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Written agreement to take part stating that he or she understands the purpose of the study and the procedures involved and...
- ✓Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- ✓Age ≥ 18 years.
- ✓activity scale (ECOG) performance status of 0-1
- ✓Decline or ineligible ("unfit") for cisplatin-based drug treatment
Who cannot take part
- ✗Clinical evidence of N2-N3 tumours or that has spread bladder cancer.
- ✗Has tumour with any neuroendocrine or small cell component.
- ✗Patients who are not considered fit for cystectomy or reject cystectomy.
- ✗Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )treatment that goes through your whole body.
- ✗Prior treatment that goes through your whole body, radiotherapy, or surgery for bladder cancer
See the full criteria
Where Is This Study? (5 UK sites)
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster LA1 4RP, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
Barts Health NHS Trust
London W6 8JA, United Kingdom
Charing Cross Hospital
London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SJ, United Kingdom
How to Get in Touch
Isabel Grau
Sponsor contactCONTACT