Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
NCT Number: NCT06511648
Acronym: SOGUG-NEOWIN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Muscle-invasive Bladder Cancer
Interventions: DRUG: Erdafitinib monotherapy|DRUG: Cetrelimab and Erdafitinib combination
Sponsor: Spanish Oncology Genito-Urinary Group
Collaborators: Janssen-Cilag Ltd.|Pivotal S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-07
Completion Date: 2029-03
Locations: CLCC Jean Perrin, Clermont-Ferrand, 63011, France|CLCC Léon Bérard, Lyon, 69008, France|Institut Mutualiste Montsouris, Paris, 75014, France|IUCT, Toulouse, 31059, France|Institut Gustave Roussy, Villejuif, 94805, France|IRCCS San Raffaele Hospital and Scientific Institute, Milan, 20132, Italy|Ospedale Molinette, Turin, 10126, Italy|A.O. Ordine Mauriziano, Ospedale Umberto I, Turi, 10128, Italy|Hospital Clínic De Barcelona, Barcelona, Cataluña, 08036, Spain|Hospital De Sabadell (Parc Taulí), Barcelona, Cataluña, 08208, Spain|Complexo Hospitalario Universitario A Coruña, Coruña, Galicia, 15006, Spain|Hospital Universitario Lucus Augusti, Lugo, Galicia, 27003, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|Fundación Instituto Valenciano De Oncología, Valencia, 46009, Spain|University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, LA1 4RP, United Kingdom|The Royal Marsden NHS Foundation Trust, London, SW3 6JJ, United Kingdom|Barts Health NHS Trust, London, W6 8JA, United Kingdom|Charing Cross Hospital, London, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2SJ, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Rate of pathological downstaging (pDS), Defined as pathological TNM less than clinical TNM., 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)., During follow-up period (36 months)|Overall Survival, Defined from the date of study entry until death of any cause., 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., 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, 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, During treatment (27 months) and follow-up period (36 months)