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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study. 2. diagnosed by tissue sample (biopsy-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. your organs (liver, kidneys, etc.) are working well enough based on blood tests 9. No other malignancy 10. Willingness to avoid pregnancy or fathering children Who Should NOT Join This Trial: 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. previous cancer treatment that works throughout the body (like chemotherapy), radiation therapy, or surgery for bladder cancer Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Erdafitinib monotherapy

Patients will receive treatment with erdafitinib alone (cohort 1)

DRUG

Cetrelimab and Erdafitinib combination

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

Locations (20)

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