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New treatment option for Muscle-invasive Bladder Cancer
Official title Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
ClinicalTrials.gov ID: NCT06511648
What this study is testing
What is Erdafitinib monotherapy?
Erdafitinib monotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for muscle-invasive bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the...
- Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor...
- Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
You likely can't join if
- Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
- Has tumour with any neuroendocrine or small cell component.
- Patients who are not considered fit for cystectomy or reject cystectomy.
- Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
See the full eligibility criteria
- 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.
- 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.
- Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Decline or ineligible ("unfit") for cisplatin-based chemotherapy
- Presence of a selected FGFR alteration on analysis of tumour biopsy
- Adequate organ function
- No other malignancy
- Willingness to avoid pregnancy or fathering children
- Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
- Has tumour with any neuroendocrine or small cell component.
- Patients who are not considered fit for cystectomy or reject cystectomy.
- Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Lyon, France
- Paris, France
- Toulouse, France
- Villejuif, France
- Milan, Italy
- Turi, Italy
- Turin, Italy
- Barcelona, Catalonia, Spain
- A Coruña, Galicia, Spain
- Lugo, Galicia, Spain
- Barcelona, Spain
- Madrid, Spain
- Toledo, Spain
- Valencia, Spain
- Valladolid, Spain
- Zaragoza, Spain
- Lancaster, United Kingdom
- London, United Kingdom
- Sheffield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Lyon, France; Paris, France; Toulouse, France; Villejuif, France; Milan, Italy and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.