A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS- 986205, Followed by Continued Post- Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer
Date de révision : 23/04/2026
76 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 26/06/2024
Date de fin de recrutement : 26/06/2024
Critères :
Critères d'inclusion :
- Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component.
- Participant must be deemed eligible for RC by his/her oncologist and/or urologist, and must agree to undergo RC after completion of neoadjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Critères d'exclusion :
- Clinical evidence of positive LN (≥ 10 mm in short axis) or metastatic bladder cancer
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted
- Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Les Hopitaux Universitaires De Strasbourg
67098 Strasbourg Cedex 2 France
Assistance Publique Hopitaux De Paris
94010 Creteil Cedex France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".