None listed
Conditions
Interventions
Arm A: Nivolumab (Solution for Injection 10mg/mL) 240 mg administered every 2 weeks as a 30 minute Intra-venous infusion.
Arm B: Placebo for Nivolumab/Ipilimumab (0.9% sodium chloride injection or
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subjects must be status post radical surgical resection (R0) for MIBC performed within 90 days prior to randomization. 2) Must have pathologic evidence of urothelial carcinoma at high risk of recurrence who have or not received neo-adjuvant cisplatin chemotherapy. 3) Dominant component of histology needs to be urothelial carcinoma or transitional cell carcinoma. 4) All subjects must have disease-free status (N0M0) defined as no measurable disease by RECIST 1.1within 4 weeks prior to randomization. 5) Tumor tissue from the most recently resected site of disease. Subject must have a PD-L1 expression level classification (≥ 1%, < 1%, indeterminate). 6) Life expectancy ≥ 6 months 7) ECOG performance status 0 or 1.
Exclusion criteria
Exclusion criteria: 1. Partial cystectomy in the setting of bladder cancer primary tumor or partial nephrectomy in the setting of renal pelvis primary tumor. 2. Adjuvant systemic or radiation therapy for urothelial or prostatic carcinoma following radical surgical resection of urothelial carcinoma. 3. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration. 4. Prior malignancy active within the previous 3 years. 5. Subjects with active, known or suspected autoimmune disease. 6. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration. 7. Subjects with history of life-threatening toxicity related to prior immune therapy. 8. All toxicities attributed to prior anti-cancer therapy other than nephropathy, neuropathy, hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. 9. Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea South, Mexico, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Tanzania, Tayikistan, Timor-Leste, Tonga, Tunisia, United Kindgdom, United States
Contacts
Public ContactEva Paredes
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed