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
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03036098
This clinical trial evaluates the efficacy of nivolumab with ipilimumab or chemotherapy versus chemotherapy alone in untreated inoperable or metastatic urothelial cancer. Eligible participants must have metastatic or inoperable transitional cell cancer, no prior systemic chemotherapy, and an ECOG performance status of 0 or 1. Interventions include nivolumab, ipilimumab, gemcitabine, cisplatin, and carboplatin.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0001 | 99503 | Anchorage | Alaska |
| Local Institution - 0115 | 93703 | Fresno | California |
| St Joseph Heritage Healthcare | 95403 | Santa Rosa | California |
| Local Institution - 0051 | 33486 | Boca Raton | Florida |
| Local Institution - 0087 | 33308 | Fort Lauderdale | Florida |
| Local Institution - 0062 | 32256 | Jacksonville | Florida |
| Local Institution - 0004 | 30607 | Athens | Georgia |
| Local Institution - 0033 | 31792 | Thomasville | Georgia |
| Local Institution - 0046 | 60612 | Chicago | Illinois |
| Local Institution - 0117 | 70121 | New Orleans | Louisiana |
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