Muscle-Invasive Bladder Cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT) and confirmed by radiographic imaging. - Must be deemed eligible for RC by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Cisplatin-ineligible participants will be defined by any one of the following criteria: i) Impaired renal function (glomerular filtration rate [GFR] = 30 but =65 years) yes F.1.3.1 Number of subjects for this age range 504
Exclusion criteria
Exclusion criteria: - Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer. - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment. - Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC. - History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event. Other protocol defined inclusion/exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the pCR rate of neoadjuvant nivolumab + bempegto Standard of Care (SOC, no neoadjuvant therapy) in all randomized participants - To compare the event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after radical cystectomy (RC) versus SOC (no neoadjuvant or adjuvant therapy);Secondary Objective: - To compare the pCR rate of neoadjuvant nivolumab monotherapy to SOC (no neoadjuvant therapy) at the time of surgery - To compare the EFS of neoadjuvant nivolumab followed by adjuvant nivolumab versus SOC - To compare the overall survival (OS) of each experimental arm versus SOC - To assess safety and tolerability for each treatment arm - To evaluate (descriptively) the pCR rate of neoadjuvant nivolumab + bempegaldesleukin to neoadjuvant nivolumab monotherapy in all randomized participants -To evaluate (descriptively) the EFS of neoadjuvant nivolumab + bempegaldesleukin followed by adjuvant nivolumab + bempegaldesleukin after radical cystectomy (RC) versus neoadjuvant nivolumab followed by adjuvant nivolumab after RC in all randomized participants;Primary end point(s): - Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants - Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC;Timepoint(s) of evaluation of this end point: - Approximately 36 months - Approximately 54 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants. - EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC - Overall survival - Incidence of adverse events (AEs), of serious adverse events (SAEs), of AEs leading to discontinuation, of immune-mediated AEs (imAEs), of laboratory abnormalities - pCR rate, defined by the proportion of randomized participants with absence of any cancer (T0, N0) in pathology specimens after RC, based on blinded independent pathology review - EFS, defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on BICR assessments, or death due to any cause ;Timepoint(s) of evaluation of this end point: - Approximately 36 months - Approximately 54 months - Approximately 74 months - Up to 5 years - Approximately 36 months - Approximately 54 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Czech Republic, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed