Erdafitinib with or without Cetrelimab for muscle-invasive bladder cancer
A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations
PHASE2 · Spanish Oncology Genito-Urinary Group · NCT06511648
This study is testing if a new drug called erdafitinib, alone or with another drug called cetrelimab, can help people with muscle-invasive bladder cancer who can’t take certain chemotherapy drugs before their surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spanish Oncology Genito-Urinary Group (other) |
| Drugs / interventions | chemotherapy, radiation, cetrelimab, Erdafitinib |
| Locations | 23 sites (Clermont-Ferrand and 22 other locations) |
| Trial ID | NCT06511648 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed MIBC and specific FGFR gene alterations who are ineligible for or refuse cisplatin-based chemotherapy.
Not a fit: Patients with metastatic bladder cancer or those with tumors containing neuroendocrine or small cell components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with MIBC who cannot tolerate standard chemotherapy.
How similar studies have performed: While this approach is novel in the context of combining erdafitinib with cetrelimab for this specific patient population, previous studies have shown promise with FGFR-targeted therapies in bladder cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Clermont-Ferrand and 22 other locations
- CLCC Jean Perrin — Clermont-Ferrand, France (RECRUITING)
- CLCC Léon Bérard — Lyon, France (WITHDRAWN)
- 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)
- A.O. Ordine Mauriziano, Ospedale Umberto I — Turi, Italy (WITHDRAWN)
- Ospedale Molinette — Turin, Italy (RECRUITING)
- Hospital Clínic De Barcelona — Barcelona, Catalonia, Spain (RECRUITING)
- Hospital De Sabadell (Parc Taulí) — Barcelona, Catalonia, Spain (RECRUITING)
- Complexo Hospitalario Universitario A Coruña — A Coruña, Galicia, Spain (RECRUITING)
- Hospital Universitario Lucus Augusti — Lugo, Galicia, Spain (RECRUITING)
- ICO l' Hospitalet — Barcelona, Spain (NOT_YET_RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- Hospital Universitario de Toledo — Toledo, Spain (RECRUITING)
- Fundación Instituto Valenciano De Oncología — Valencia, Spain (RECRUITING)
- Hospital Clínico Universitario De Valladolid — Valladolid, Spain (RECRUITING)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (RECRUITING)
- University Hospitals of Morecambe Bay NHS Foundation Trust — Lancaster, United Kingdom (WITHDRAWN)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Barts Health NHS Trust — London, United Kingdom (RECRUITING)
- Charing Cross Hospital — London, United Kingdom (RECRUITING)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Isabel Grau
- Email: trialmanager@sogug.es
- Phone: 0034610286915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Muscle-invasive Bladder Cancer, Urothelial carcinoma