Brief Title: 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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival (OS) in cisplatin-ineligible randomized participants

Primary Outcome 1 - Timeframe: Up to 55 months

Primary Outcome 2 - Measure: Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)

Primary Outcome 2 - Timeframe: Up to 52 months

Primary Outcome 3 - Measure: 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

Primary Outcome 3 - Timeframe: Up to 64 months

Primary Outcome 4 - Measure: Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC

Primary Outcome 4 - Timeframe: Up to 64 months

CONDITION

• Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra

- No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Women and men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
Disease that is suitable for local therapy administered with curative intent

- Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION