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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

Trial Status: Active

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.

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


VA Central California Fresno Medical Center
Status: ACTIVE
Contact: Laura B Peters
Phone: 559-225-6100ext5610


Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Status: ACTIVE
South Weymouth
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Status: ACTIVE


Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Mexico

Presbyterian Kaseman Hospital
Status: ACTIVE
University of New Mexico Cancer Center
Status: ACTIVE

New York

Roswell Park Cancer Institute
NYU Winthrop Hospital
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

North Carolina

Duke University Medical Center
Status: ACTIVE


Ohio State University Comprehensive Cancer Center
Status: ACTIVE


Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-901
  • Secondary IDs NCI-2017-02285, 2016-003881-14
  • ID NCT03036098