RecruitingPhase 2NCT06511648

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

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

Sponsor

Spanish Oncology Genito-Urinary Group

Enrollment

90 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Muscle Invasive Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted drug called erdafitinib, alone or combined with an immunotherapy drug called cetrelimab, for people with muscle-invasive bladder cancer who have a specific genetic change in their tumor called an FGFR alteration. These drugs work by targeting the specific mutation driving the cancer. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer (stage T2-4a) - Your tumor has been tested and confirmed to have an FGFR gene alteration - You are 18 years or older with good physical functioning (ECOG 0-1) - You are unable or unwilling to receive cisplatin-based chemotherapy - Your main tumor type is urothelial (bladder lining) cancer making up at least 50% of the tumor - You have adequate organ function **You may NOT be eligible if...** - Your cancer has spread to distant lymph nodes (N2-N3) or other organs (metastatic) - Your tumor contains neuroendocrine or small cell components - You have had prior immunotherapy (anti-PD-1/PD-L1) treatment - You have uncontrolled autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGErdafitinib monotherapy

Patients will receive treatment with erdafitinib alone (cohort 1)

DRUGCetrelimab and Erdafitinib combination

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

Locations(23)

CLCC Jean Perrin

Clermont-Ferrand, France

CLCC Léon Bérard

Lyon, France

Institut Mutualiste Montsouris

Paris, France

IUCT

Toulouse, France

Institut Gustave Roussy

Villejuif, France

IRCCS San Raffaele Hospital and Scientific Institute

Milan, Italy

A.O. Ordine Mauriziano, Ospedale Umberto I

Turi, Italy

Ospedale Molinette

Turin, Italy

Hospital Clínic De Barcelona

Barcelona, Catalonia, Spain

Hospital De Sabadell (Parc Taulí)

Barcelona, Catalonia, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

ICO l' Hospitalet

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de Toledo

Toledo, Spain

Fundación Instituto Valenciano De Oncología

Valencia, Spain

Hospital Clínico Universitario De Valladolid

Valladolid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06511648

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