Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036098
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : May 16, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date May 16, 2023
Actual Study Start Date  ICMJE March 24, 2017
Estimated Primary Completion Date June 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2020)
  • Overall survival (OS) in cisplatin-ineligible randomized participants [ Time Frame: Up to 55 months ]
  • Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) [ Time Frame: 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 [ Time Frame: Up to 64 months ]
  • Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [ Time Frame: Up to 64 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Progression free survival (PFS) in cisplatin-ineligible participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 41 months ]
  • Overall survival (OS) of cisplatin-ineligible participants [ Time Frame: Up to 41 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2020)
  • Overall survival (OS) in all randomized participants [ Time Frame: Up to 55 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 [ Time Frame: Up to 55 months ]
  • 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 [ Time Frame: Up to 55 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 [ Time Frame: Up to 55 months ]
  • European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants [ Time Frame: 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 [ Time Frame: Up to 64 months ]
  • Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]
  • Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • Progression free survival (PFS) in all participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 41 months ]
  • Overall survival (OS) in all participants [ Time Frame: Up to 41 months ]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score [ Time Frame: Up to 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified Dose on Specified Days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    Specified Dose on Specified Days
    Other Names:
    • BMS-734016
    • Yervoy
  • Drug: Gemcitabine
    Specified Dose on Specified Days
  • Drug: Cisplatin
    Specified Dose on Specified Days
  • Drug: Carboplatin
    Specified Dose on Specified Days
Study Arms  ICMJE
  • Experimental: Arm A: Investigational immunotherapy
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Active Comparator: Arm B: Standard of care chemotherapy
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Drug: Carboplatin
  • Experimental: Arm C: Investigational immunotherapy
    Interventions:
    • Biological: Nivolumab
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Active Comparator: Arm D: Standard of care chemotherapy
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2022)		 1307
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2017)		 690
Estimated Study Completion Date  ICMJE July 15, 2025
Estimated Primary Completion Date June 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United States
Removed Location Countries Hungary
 
Administrative Information
NCT Number  ICMJE NCT03036098
Other Study ID Numbers  ICMJE CA209-901
2016-003881-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP