OncoMatch/Clinical Trials/NCT06511648
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Is NCT06511648 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Erdafitinib monotherapy and Cetrelimab and Erdafitinib combination for muscle-invasive bladder cancer.
Treatment: Erdafitinib monotherapy · Cetrelimab and Erdafitinib combination — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR1 selected alteration
Presence of a selected FGFR alteration on analysis of tumour biopsy
Required: FGFR2 selected alteration
Presence of a selected FGFR alteration on analysis of tumour biopsy
Required: FGFR3 selected alteration
Presence of a selected FGFR alteration on analysis of tumour biopsy
Required: FGFR4 selected alteration
Presence of a selected FGFR alteration on analysis of tumour biopsy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: FGFR-targeted therapy
Prior FGFR-targeted...systemic therapy
Cannot have received: immune checkpoint inhibitor (anti-PD-1, anti-PD-L1)
Prior...immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy
Cannot have received: systemic therapy
Prior systemic therapy...for bladder cancer
Cannot have received: radiation therapy
Prior...radiation therapy...for bladder cancer
Cannot have received: surgery
Prior...surgery for bladder cancer
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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