Erdafitinib with or without Cetrelimab for muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of erdafitinib, both alone and in combination with cetrelimab, as a neoadjuvant treatment for patients with muscle-invasive bladder cancer (MIBC) who have specific FGFR gene alterations and are not eligible for or have declined cisplatin-based chemotherapy. The study aims to measure the antitumor activity by assessing the rate of pathological complete response (pCR) and tumor downstaging after treatment. Eligible patients will receive either treatment before undergoing radical cystectomy within a specified timeframe. The trial includes radiological assessments to monitor treatment response.

Why it matters

Who can join: the full rules

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

Where it's running

• CLCC Jean Perrin
  Clermont-Ferrand, France Recruiting
• Institut Mutualiste Montsouris
  Paris, France Recruiting
• Iuct
  Toulouse, France Recruiting
• Institut Gustave Roussy
  Villejuif, France Recruiting
• IRCCS San Raffaele Hospital and Scientific Institute
  Milan, Italy Recruiting
• Ospedale Molinette
  Turin, Italy Recruiting

Study contacts

• Study coordinator: Isabel Grau
• Email: trialmanager@sogug.es
• Phone: 0034610286915

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tetra-modality bladder-preservation approach in muscle-invasive bladder cancer

  This trial tests whether adding the immunotherapy drug avelumab to tumor removal, chemotherapy, and radiation can help people with muscle-invasive bladder cancer keep their bladder.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.