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.
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.
Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
Has tumour with any neuroendocrine or small cell component.
Patients who are not considered fit for cystectomy or reject cystectomy.
Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
Parallel
Erdafitinib monotherapy
DrugPatients will receive treatment with erdafitinib alone (cohort 1)
Cetrelimab and Erdafitinib combination
DrugPatients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)
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.
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)."
Rate of pathological downstaging (pDS)
Defined as pathological TNM less than clinical TNM.
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).
Overall Survival
Defined from the date of study entry until death of any cause.
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.
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Spanish Oncology Genito-Urinary Group
Lead sponsor
Janssen-Cilag Ltd.
Collaborator
Pivotal S.L.
Collaborator
