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

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.

Trial Details

NCT ID
NCT06511648
Phase
PHASE2
Sponsor
Spanish Oncology Genito-Urinary Group
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Erdafitinib monotherapy
  • Cetrelimab and Erdafitinib combination
Locations (sample)
  • Clermont-Ferrand, France|45.77969,3.08682
  • Lyon, France|45.74906,4.84789
  • Paris, France|48.85341,2.3488
  • Toulouse, France|43.60426,1.44367
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the s…
  • Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TU…
  • Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
  • Age ≥ 18 years.

For full eligibility, visit ClinicalTrials.gov.

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