Active, Not Recruiting

Trial ID CA209-901 | NCT03036098

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 3
18+

Age Range
Active, Not Recruiting

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.

Key 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

Additional Information *

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A: Investigational immunotherapy

ASSIGNED INTERVENTION

Biological: Nivolumab, Ipilimumab

Study Arms

Active Comparator: Arm B: Standard of care chemotherapy

ASSIGNED INTERVENTION

Drug: Gemcitabine, Cisplatin, Carboplatin

Study Arms

Experimental: Arm C: Investigational immunotherapy

ASSIGNED INTERVENTION

Biological: Nivolumab
Drug: Gemcitabine, Cisplatin

Study Arms

Active Comparator: Arm D: Standard of care chemotherapy

ASSIGNED INTERVENTION

Drug: Gemcitabine, Cisplatin

Trial ID CA209-901 | NCT03036098

Summary

Overview

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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