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
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CLCC Jean Perrin
RECRUITING
Clermont-ferrand
CLCC Léon Bérard
WITHDRAWN
Lyon
Institut Mutualiste Montsouris
RECRUITING
Paris
IUCT
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Italy
IRCCS San Raffaele Hospital and Scientific Institute
RECRUITING
Milan
A.O. Ordine Mauriziano, Ospedale Umberto I
WITHDRAWN
Turi
Ospedale Molinette
RECRUITING
Turin
Spain
Complexo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Clínic De Barcelona
RECRUITING
Barcelona
Hospital De Sabadell (Parc Taulí)
RECRUITING
Barcelona
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Fundación Instituto Valenciano De Oncología
RECRUITING
Valencia
United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
RECRUITING
Lancaster
Barts Health NHS Trust
RECRUITING
London
Charing Cross Hospital
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Isabel Grau
trialmanager@sogug.es
0034610286915
Time Frame
Start Date:2023-03-07
Estimated Completion Date:2029-03
Participants
Target number of participants:90
Treatments
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)
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)