Muscle-invasive Bladder CancerPhase 2SOGUG-NEOWINNCT06511648
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
A Phase 2 study testing Erdafitinib monotherapy and Cetrelimab and Erdafitinib combination in people with Muscle-invasive Bladder Cancer, run by Spanish Oncology Genito-Urinary Group at 23 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-invasive Bladder Cancer
- What is being tested?
- Erdafitinib monotherapy and Cetrelimab and Erdafitinib combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 7 Mar 2023to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.
- Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit.
- Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Decline or ineligible ("unfit") for cisplatin-based chemotherapy
Show all 10Show fewer
- Presence of a selected FGFR alteration on analysis of tumour biopsy
- Adequate organ function
- No other malignancy
- Willingness to avoid pregnancy or fathering children
Who cannot join
- Clinical evidence of N2-N3 tumours or metastatic 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 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Trial locations and contacts
23 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 4 countries
Spain10 sites, 10 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Aurea Molina, MD, PhD
aurea.molina.diaz@sergas.es
- Recruiting
Hospital Clínic De Barcelona
Barcelona, Catalonia, 08036
Oscar Reig, MD, PhD.
OREIG@clinic.cat
- Recruiting
Hospital De Sabadell (Parc Taulí)
Barcelona, Catalonia, 08208
Teresa Bonfill, MD, PhD., TBonfill@tauli.cat
- Not yet recruiting
ICO l' Hospitalet
Barcelona, 08908
Irene Ortiz Rubio, MD, PhD, ireneortiz@iconcologia.net
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Sergio Vázque, MD, PhD
sergio.vazquez.estevez@sergas.es
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Guillermo De Velasco, MD, PhD, guillermoantonio.velasco@salud.madrid.org
- Recruiting
Hospital Universitario de Toledo
Toledo, 45007
Iciar García Carbonero, MD, PhD, igcarbonero@yahoo.es
- Recruiting
Fundación Instituto Valenciano De Oncología
Valencia, 46009
Maria José Juan, MD, Phd, mjuanfi81@hotmail.com
- Recruiting
Hospital Clínico Universitario De Valladolid
Valladolid, 47003
Ricardo Sánchez-Escribano, MD, PhD, rsescribano@seom.org
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Carmen Santander Lobera, MD, PhD, csantlob@yahoo.es
France5 sites, 4 recruiting
- Recruiting
CLCC Jean Perrin
Clermont-Ferrand, 63011
Hakim Mahammedi, MD and PhD, hakim.mahammedi@clermont.unicancer.fr
- Withdrawn
CLCC Léon Bérard
Lyon, 69008
- Recruiting
Institut Mutualiste Montsouris
Paris, 75014
Marie-Liesse Joulia, MD, PhD, marie-liesse.joulia@imm.fr
- Recruiting
IUCT
Toulouse, 31059
Damien Poussel, MD, PhD, pouessel.damien@iuct-oncopole.fr
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Yohann Loriot, MD, PhD, Yohann.LORIOT@gustaveroussy.fr
United Kingdom5 sites, 4 recruiting
- Withdrawn
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, LA1 4RP
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Vincent Khoo, MD, PhD, VincentPA.Khoo@rmh.nhs.uk
- Recruiting
Barts Health NHS Trust
London, W6 8JA
Tomas Powles, MD, PhD, thomas.powles1@nhs.net
- Recruiting
Charing Cross Hospital
London
Naveed Sarwar, MD, PhD, naveed.sarwar1@nhs.net
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ
Syed Hussain, MD, PhD, syed.hussain@sheffield.ac.uk
Italy3 sites, 2 recruiting
- Recruiting
IRCCS San Raffaele Hospital and Scientific Institute
Milan, 20132
Andrea Necchi, MD, PhD, necchi.andrea@hsr.it
- Withdrawn
A.O. Ordine Mauriziano, Ospedale Umberto I
Turi, 10128
- Recruiting
Ospedale Molinette
Turin, 10126
Paolo Gontero, MD, PhD, paolo.gontero@unito.it
About this study
Official title: A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations
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.
Read the detailed description
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 .
- Conditions
- Muscle-invasive Bladder Cancer
- Being tested
- Erdafitinib monotherapy, Cetrelimab and Erdafitinib combination
- Keywords
- Urothelial carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erdafitinib monotherapyDrug
Patients will receive treatment with erdafitinib alone (cohort 1)
Cetrelimab and Erdafitinib combinationDrug
Patients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)
| Study group | Role | What they receive |
|---|---|---|
| Erdafitinib (ERDA) monotherapy | Experimental | Patients will receive treatment neoadjuvant with erdafitinib alone (cohort 1: Erdafitinib) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment) Receives: Drug: Erdafitinib monotherapy |
| Erdafitinib (ERDA) and Cetrelimab (CET) combination | Experimental | Patients will receive treatment neoadjuvant with erdafitinib + cetrelimab (cohort 2: Erdafitinib + Cetrelimab) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment) Receives: Drug: Cetrelimab and Erdafitinib combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Defined as no evidence of residual disease based on pathological review of the surgical specimen.It is defined as the proportion of patients whose pathological staging was ypT0N0M0 as assessed using specimens obtained post radical cystectomy following the study intervention.
Measured: After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
Pathological downstaging response <ypT2
Defined as no microscopic evidence of residual disease in the bladder (ypT0) or evidence of non-muscle invasive residual disease including ypTa, ypTis, ypT1, based on histological evaluation of the resected bladder specimen collected during cystectomy (post-treatment)."
Measured: After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
Secondary outcomes (6)
Rate of pathological downstaging (pDS)
Defined as pathological TNM less than clinical TNM.
Measured: During treatment (27 months)
Event-free Survival rate.
Radiographically confirmed disease progression of their cancer, death or any event that prevents the performance of RC, including initiation of any additional therapy prior to RC. Progression will be assessed using computed tomography (CT)/magnetic resonance imaging (MRI) and/or Positron Emission Tomography (PET)-CT (per standard local imaging practices).
Measured: During follow-up period (36 months)
Overall Survival
Defined from the date of study entry until death of any cause.
Measured: During follow-up period (36 months)
Overall Response Rate
Defined as the percentage of patients with partial or complete response according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Measured: During treatment (27 months)
Adverse events.
Occurring in the period from the time the patient enters the study (from the signature of consent) until 30 days after the last dose of the investigational treatment erdafitinib and until 100 days after the last dose of the investigational treatment cetrelimab
Measured: During treatment (27 months) and follow-up period (36 months)
Rate of delay of surgery
classed as a delay event if performed > 6 weeks after last dose of treatment
Measured: During treatment (27 months) and follow-up period (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start7 Mar 2023
- Primary completionJul 2026 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd., Pivotal S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511648
- Sponsor's protocol ID
- SOGUG-2020-IEC(VEJ)-11
- Other IDs
- 2022-002586-15, 2024-512573-27-01
- Acronym
- SOGUG-NEOWIN
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations
- ClinicalTrials.gov ID
- NCT06511648
- Acronym / sponsor ID
- SOGUG-NEOWIN / SOGUG-2020-IEC(VEJ)-11
- Conditions
- Muscle-invasive Bladder Cancer
- Keywords
- Urothelial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd., Pivotal S.L.
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erdafitinib (ERDA) monotherapy | Experimental | Drug: Erdafitinib monotherapyPatients will receive treatment neoadjuvant with erdafitinib alone (cohort 1: Erdafitinib) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment) |
| Erdafitinib (ERDA) and Cetrelimab (CET) combination | Experimental | Drug: Cetrelimab and Erdafitinib combinationPatients will receive treatment neoadjuvant with erdafitinib + cetrelimab (cohort 2: Erdafitinib + Cetrelimab) before proceeding to radical cystectomy (RC) (to be performed within 2 - 6 weeks after the end of treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.
- Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit.
- Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (5 listed)
- Clinical evidence of N2-N3 tumours or metastatic 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 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erdafitinib monotherapyPatients will receive treatment with erdafitinib alone (cohort 1) | Drug | Erdafitinib (ERDA) monotherapy |
| Cetrelimab and Erdafitinib combinationPatients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2) | Drug | Erdafitinib (ERDA) and Cetrelimab (CET) combination |
Primary outcome
Pathological complete response (pCR)
Time frame: After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
Defined as no evidence of residual disease based on pathological review of the surgical specimen.It is defined as the proportion of patients whose pathological staging was ypT0N0M0 as assessed using specimens obtained post radical cystectomy following the study intervention.
Pathological downstaging response <ypT2
Time frame: After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
Defined as no microscopic evidence of residual disease in the bladder (ypT0) or evidence of non-muscle invasive residual disease including ypTa, ypTis, ypT1, based on histological evaluation of the resected bladder specimen collected during cystectomy (post-treatment)."
6 secondary outcomes
Rate of pathological downstaging (pDS)
Time frame: During treatment (27 months)
Event-free Survival rate.
Time frame: During follow-up period (36 months)
Overall Survival
Time frame: During follow-up period (36 months)
Overall Response Rate
Time frame: During treatment (27 months)
Adverse events.
Time frame: During treatment (27 months) and follow-up period (36 months)
Rate of delay of surgery
Time frame: During treatment (27 months) and follow-up period (36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erdafitinib monotherapy and Cetrelimab and Erdafitinib combination in people with Muscle-invasive Bladder Cancer, run by Spanish Oncology Genito-Urinary Group at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain, France, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Grau (0034610286915, trialmanager@sogug.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.