NCT06511648

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
41mo left

Started Mar 2023

Longer than P75 for phase_2

Geographic Reach
4 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Mar 2023Oct 2029

Study Start

First participant enrolled

March 7, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

July 15, 2024

Last Update Submit

December 12, 2025

Conditions

Muscle-invasive Bladder Cancer

Keywords

Urothelial carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)."

    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)

    During treatment (27 months)

  • Event-free Survival rate.

    During follow-up period (36 months)

  • Overall Survival

    During follow-up period (36 months)

  • Overall Response Rate

    During treatment (27 months)

  • Adverse events.

    During treatment (27 months) and follow-up period (36 months)

  • +1 more secondary outcomes

Study Arms (2)

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)

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)

Drug: Cetrelimab and Erdafitinib combination

Interventions

Cetrelimab and Erdafitinib combinationDRUG

Patients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)

Erdafitinib (ERDA) and Cetrelimab (CET) combination
Erdafitinib monotherapyDRUG

Patients will receive treatment with erdafitinib alone (cohort 1)

Erdafitinib (ERDA) monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Presence of a selected FGFR alteration on analysis of tumour biopsy
  • Adequate organ function
  • No other malignancy
  • Willingness to avoid pregnancy or fathering children

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

CLCC Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

CLCC Léon Bérard

Lyon, 69008, France

WITHDRAWN

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

IUCT

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

IRCCS San Raffaele Hospital and Scientific Institute

Milan, 20132, Italy

RECRUITING

A.O. Ordine Mauriziano, Ospedale Umberto I

Turi, 10128, Italy

WITHDRAWN

Ospedale Molinette

Turin, 10126, Italy

RECRUITING

Hospital Clínic De Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Hospital De Sabadell (Parc Taulí)

Barcelona, Catalonia, 08208, Spain

RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, 15006, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

RECRUITING

ICO l' Hospitalet

Barcelona, 08908, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario de Toledo

Toledo, 45007, Spain

RECRUITING

Fundación Instituto Valenciano De Oncología

Valencia, 46009, Spain

RECRUITING

Hospital Clínico Universitario De Valladolid

Valladolid, 47003, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, LA1 4RP, United Kingdom

WITHDRAWN

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Barts Health NHS Trust

London, W6 8JA, United Kingdom

RECRUITING

Charing Cross Hospital

London, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Isabel Grau

CONTACT

0034610286915trialmanager@sogug.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 22, 2024

Study Start

March 7, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2029

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(10)FR(5)GB(5)IT(3)