Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Spanish Oncology Genito-Urinary Group (Voir sur ClinicalTrials)
mars 2023
mars 2029
12 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann Loriot, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLCC Jean Perrin - 63011 - Clermont-Ferrand - France | Hakim Mahammedi, MD and PhD | Contact (sur clinicalTrials) | |||
| CLCC Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Institut Mutualiste Montsouris - 75014 - Paris - France | Marie-Liesse Joulia, MD, PhD | Contact (sur clinicalTrials) | |||
| IUCT - 31059 - Toulouse - France | Damien Poussel, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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