Clinical Trials Detalhe
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Visão Geral
Gender
ALL
Idade
N/A
Fase
PHASE3
Tipo de Estudo
INTERVENTIONAL
Localização
Local Institution - 0153 (Lisboa, Portugal)
Local Institution - 0152 (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT03661320Sumário
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Condições
Urinary Bladder Neoplasms
Muscle-Invasive Bladder Cancer
Elegibilidade
Inclusion Criteria: * 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 Exclusion Criteria: * Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer * Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted