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

Running, not enrolling · Phase 3

Conditions studied: Urothelial Cancer

In brief

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Key facts

Study ID

NCT03036098

Run by

Bristol-Myers Squibb

People needed

1314

Starts

2017-03-24

Expected to finish

2026-05-15

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0115 — Fresno, California, United States
• St Joseph Heritage Healthcare — Santa Rosa, California, United States
• Local Institution - 0051 — Boca Raton, Florida, United States
• Local Institution - 0087 — Fort Lauderdale, Florida, United States
• Local Institution - 0062 — Jacksonville, Florida, United States
• Local Institution - 0004 — Athens, Georgia, United States
• Local Institution - 0033 — Thomasville, Georgia, United States
• Local Institution - 0046 — Chicago, Illinois, United States
• Local Institution - 0117 — New Orleans, Louisiana, United States
• Local Institution - 0056 — Boston, Massachusetts, United States
• Local Institution - 0073 — Boston, Massachusetts, United States
• Local Institution - 0208 — Boston, Massachusetts, United States
• Local Institution - 0207 — Milford, Massachusetts, United States
• Local Institution - 0063 — Ann Arbor, Michigan, United States
• Local Institution - 0002 — Burnsville, Minnesota, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Local Institution - 0032 — Kansas City, Missouri, United States
• Local Institution - 0095 — St Louis, Missouri, United States
• Local Institution - 0057 — Manchester, New Hampshire, United States
• Local Institution - 0084 — Albuquerque, New Mexico, United States
• Local Institution - 0083 — Buffalo, New York, United States
• Local Institution - 0014 — Mineola, New York, United States
• Local Institution - 0072 — New York, New York, United States
• Local Institution - 0116 — Durham, North Carolina, United States
• Local Institution - 0001 — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.