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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.

Phase 2RecruitingSpanish Oncology Genito-Urinary GroupNCT06511648Data as of May 2026

Treatment: Erdafitinib monotherapy · Cetrelimab and Erdafitinib combinationErdafitinib (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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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