Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations (SOGUG-NEOWIN)

December 12, 2025 updated by: Spanish Oncology Genito-Urinary Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Hospital and Scientific Institute
        • Contact:
      • Turi, Italy, 10128
        • Withdrawn
        • A.O. Ordine Mauriziano, Ospedale Umberto I
      • Turin, Italy, 10126
  • Spain
      • Barcelona, Spain, 08908
      • Madrid, Spain, 28041
      • Toledo, Spain, 45007
        • Recruiting
        • Hospital Universitario de Toledo
        • Contact:
      • Valencia, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología
        • Contact:
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Oscar Reig, MD, PhD.
        • Contact:
          • OREIG@clinic.cat
      • Barcelona, Catalonia, Spain, 08208
        • Recruiting
        • Hospital De Sabadell (Parc Taulí)
        • Contact:
    • Galicia
      • A Coruña, Galicia, Spain, 15006
      • Lugo, Galicia, Spain, 27003
  • United Kingdom
      • Lancaster, United Kingdom, LA1 4RP
        • Withdrawn
        • University Hospitals of Morecambe Bay NHS Foundation Trust
      • London, United Kingdom, SW3 6JJ
      • London, United Kingdom
      • London, United Kingdom, W6 8JA
      • Sheffield, United Kingdom, S10 2SJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
  4. Age ≥ 18 years.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  6. Decline or ineligible ("unfit") for cisplatin-based chemotherapy
  7. Presence of a selected FGFR alteration on analysis of tumour biopsy
  8. Adequate organ function
  9. No other malignancy
  10. Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

  1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
  2. Has tumour with any neuroendocrine or small cell component.
  3. Patients who are not considered fit for cystectomy or reject cystectomy.
  4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
  5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erdafitinib (ERDA) monotherapy
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)
Drug: Erdafitinib monotherapy
Patients will receive treatment with erdafitinib alone (cohort 1)
Experimental: Erdafitinib (ERDA) and Cetrelimab (CET) combination
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)
Drug: Cetrelimab and Erdafitinib combination
Patients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
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)."
After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pathological downstaging (pDS)
Time Frame: During treatment (27 months)
Defined as pathological TNM less than clinical TNM.
During treatment (27 months)
Event-free Survival rate.
Time Frame: During follow-up period (36 months)
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).
During follow-up period (36 months)
Overall Survival
Time Frame: During follow-up period (36 months)
Defined from the date of study entry until death of any cause.
During follow-up period (36 months)
Adverse events.
Time Frame: During treatment (27 months) and follow-up period (36 months)
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
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)
classed as a delay event if performed > 6 weeks after last dose of treatment
During treatment (27 months) and follow-up period (36 months)
Overall Response Rate
Time Frame: During treatment (27 months)
Defined as the percentage of patients with partial or complete response according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
During treatment (27 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Janssen-Cilag Ltd.
Pivotal S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOGUG-2020-IEC(VEJ)-11
  • 2022-002586-15 (EudraCT Number)
  • 2024-512573-27-01 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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