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

RecruitingPhase 2Ages 18 Years - anyAllSpanish Oncology Genito-Urinary Group
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. 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. 3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site. 4. Age ≥ 18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Decline or ineligible ("unfit") for cisplatin-based chemotherapy 7. Presence of a selected FGFR alteration on analysis of tumour biopsy 8. Adequate organ function 9. No other malignancy 10. Willingness to avoid pregnancy or fathering children Exclusion Criteria: 1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer. 2. Has tumour with any neuroendocrine or small cell component. 3. Patients who are not considered fit for cystectomy or reject cystectomy. 4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy. 5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer
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What it tests

  • Erdafitinib monotherapy
  • Cetrelimab and Erdafitinib combination
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Where

23 sites
CLCC Jean Perrin
Clermont-Ferrand, France
CLCC Léon Bérard
Lyon, France
Institut Mutualiste Montsouris
Paris, France
IUCT
Toulouse, France
Institut Gustave Roussy
Villejuif, France
IRCCS San Raffaele Hospital and Scientific Institute
Milan, Italy
A.O. Ordine Mauriziano, Ospedale Umberto I
Turi, Italy
Ospedale Molinette
Turin, Italy

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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