Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
- Conditions
- Urothelial Cancer
- Registration Number
- NCT03036098
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1290
Inclusion Criteria:<br><br> - Histological or cytological evidence of metastatic or surgically inoperable<br> transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter,<br> bladder or urethra<br><br> - No prior systemic chemotherapy for metastatic or surgically inoperable urothelial<br> cancer (UC)<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1<br><br> - Women and men must agree to follow specific methods of contraception, if applicable<br><br>Exclusion Criteria:<br><br> - Disease that is suitable for local therapy administered with curative intent<br><br> - Any serious or uncontrolled medical disorder in the opinion of the investigator that<br> may increase the risk associated with study participation or study drug<br> administration or interfere with the interpretation of study results<br><br> - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or<br> anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell<br> co-stimulation or checkpoint pathways<br><br>Other protocol-defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS) in cisplatin-ineligible randomized participants;Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC);Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC;Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
- Secondary Outcome Measures
Name Time Method