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

NCT ID: NCT06511648

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2029-10-31

Brief Summary

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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

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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

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Muscle-invasive Bladder Cancer

Keywords

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Urothelial carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Erdafitinib monotherapy

Intervention Type DRUG

Patients will receive treatment with erdafitinib alone (cohort 1)

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)

Group Type EXPERIMENTAL

Cetrelimab and Erdafitinib combination

Intervention Type DRUG

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

Interventions

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Erdafitinib monotherapy

Patients will receive treatment with erdafitinib alone (cohort 1)

Intervention Type DRUG

Cetrelimab and Erdafitinib combination

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Pivotal S.L.

INDUSTRY

Sponsor Role collaborator

Spanish Oncology Genito-Urinary Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CLCC Jean Perrin

Clermont-Ferrand, , France

Site Status RECRUITING

CLCC Léon Bérard

Lyon, , France

Site Status WITHDRAWN

Institut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

IUCT

Toulouse, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

IRCCS San Raffaele Hospital and Scientific Institute

Milan, , Italy

Site Status RECRUITING

A.O. Ordine Mauriziano, Ospedale Umberto I

Turi, , Italy

Site Status WITHDRAWN

Ospedale Molinette

Turin, , Italy

Site Status RECRUITING

Hospital Clínic De Barcelona

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital De Sabadell (Parc Taulí)

Barcelona, Catalonia, Spain

Site Status RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Site Status RECRUITING

ICO l' Hospitalet

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario de Toledo

Toledo, , Spain

Site Status RECRUITING

Fundación Instituto Valenciano De Oncología

Valencia, , Spain

Site Status RECRUITING

Hospital Clínico Universitario De Valladolid

Valladolid, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, , United Kingdom

Site Status WITHDRAWN

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Barts Health NHS Trust

London, , United Kingdom

Site Status RECRUITING

Charing Cross Hospital

London, , United Kingdom

Site Status RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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France Italy Spain United Kingdom

Central Contacts

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Isabel Grau

Role: CONTACT

Phone: 0034610286915

Email: [email protected]

Facility Contacts

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Hakim Mahammedi, MD and PhD

Role: primary

Marie-Liesse Joulia, MD, PhD

Role: primary

Damien Poussel, MD, PhD

Role: primary

Yohann Loriot, MD, PhD

Role: primary

Andrea Necchi, MD, PhD

Role: primary

Paolo Gontero, MD, PhD

Role: primary

Oscar Reig, MD, PhD.

Role: primary

[email protected]

Role: backup

Teresa Bonfill, MD, PhD.

Role: primary

Aurea Molina, MD, PhD

Role: primary

Role: backup

Sergio Vázque, MD, PhD

Role: primary

Role: backup

Irene Ortiz Rubio, MD, PhD

Role: primary

Guillermo De Velasco, MD, PhD

Role: primary

Iciar García Carbonero, MD, PhD

Role: primary

Maria José Juan, MD, Phd

Role: primary

Ricardo Sánchez-Escribano, MD, PhD

Role: primary

Carmen Santander Lobera, MD, PhD

Role: primary

Vincent Khoo, MD, PhD

Role: primary

Tomas Powles, MD, PhD

Role: primary

Naveed Sarwar, MD, PhD

Role: primary

Syed Hussain, MD, PhD

Role: primary

Other Identifiers

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SOGUG-2020-IEC(VEJ)-11

Identifier Type: -

Identifier Source: org_study_id

2022-002586-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-512573-27-01

Identifier Type: CTIS

Identifier Source: secondary_id