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

Condition(s) studied

Investigational drug(s) / intervention(s)

Erdafitinib monotherapy: Patients will receive treatment with erdafitinib alone (cohort 1)

Cetrelimab and Erdafitinib combination: Patients will receive treatment neoadjuvant with erdafitinib plus cetrelimab intravenously (IV).(cohort 2)

Study 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

Primary outcome measure(s)

• Pathological complete response (pCR) — After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
  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 — After a maximum of 30 weeks from the start of treatment (First Followup visit ) on specimens obtained during radical cystectomy.
  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)."

Trial sites (23)

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