Groupe d'Etude en Oncologie du Quebec

Titre	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
Protocole ID	CA017-078
ClinicalTrials.gov ID	NCT03661320
Type(s) de cancer	Vessie/urothélial
Phase	Phase III
Type étude	Clinique
Médicament	Chimiothérapie néoadjuvante seule versus avec nivolumab ou nivolumab et BMS-986205 + thérapie post-chirurgie avec nivolumab ou nivolumab et BMS-986205
Institution	CIUSSS DE L'OUEST-DE-L'ILE-DE-MONTREAL CENTRE HOSPITALIER DE ST. MARY 3830 av. Lacombe, Montréal, QC, H3T 1M5
Ville	Montréal
Investigateur(trice) principal(e)	Dr Adrian Langleben
Coordonnateur(trice)	Rachelle Dumas 514-345-3511 poste 3378
Statut	Fermé
Critètes d'éligibilité	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 Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Critètes 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

Groupe d'étude en oncologie du Québec