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
Phase 3
Active, not recruiting
- Conditions
- Urothelial Cancer
- Interventions
- Registration Number
- NCT03036098
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1322
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm D: Standard of care chemotherapy Gemcitabine - Arm C: Investigational immunotherapy Cisplatin - Arm A: Investigational immunotherapy Nivolumab - Arm C: Investigational immunotherapy Nivolumab - Arm A: Investigational immunotherapy Ipilimumab - Arm B: Standard of care chemotherapy Carboplatin - Arm B: Standard of care chemotherapy Gemcitabine - Arm B: Standard of care chemotherapy Cisplatin - Arm C: Investigational immunotherapy Gemcitabine - Arm D: Standard of care chemotherapy Cisplatin -
- Primary Outcome Measures
Name Time Method Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) Up to 52 months Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months Overall survival (OS) in cisplatin-ineligible randomized participants Up to 55 months
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants Up to 55 months Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) Up to 64 months Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants Up to 55 months European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months Overall survival (OS) in all randomized participants Up to 55 months European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Up to 55 months Progression-free survival (PFS) by BICR by PD-L1 expression at >=1% by immunohistochemistry (IHC) Up to 64 months Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants Up to 55 months
Trial Locations
- Locations (174)
Local Institution - 0001
🇺🇸Anchorage, Alaska, United States
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
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