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 (CheckMate901)

  • STATUS
    Recruiting
  • End date
    Jul 15, 2025
  • participants needed
    1307
  • sponsor
    Bristol-Myers Squibb
Updated on 11 August 2022
carboplatin
gemcitabine
nivolumab
systemic chemotherapy
metastatic urothelial carcinoma

Summary

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.

Details
Condition Urothelial Cancer
Treatment cisplatin, carboplatin, Gemcitabine, Ipilimumab, Nivolumab
Clinical Study IdentifierNCT03036098
SponsorBristol-Myers Squibb
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

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
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