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A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (CheckMate 9UT)

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ClinicalTrials.gov Identifier: NCT03519256
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date January 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC) [ Time Frame: Up to 5 years ]
  • Duration of complete response (DOCR), per PRC, in CIS participants with CR [ Time Frame: Up to 5 years ]
  • Event Free Survival (EFS), per PRC, for all non-CIS participants [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03519256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 months ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 15 months ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 15 months ]
  • Incidence of deaths [ Time Frame: Up to 5 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 15 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Official Title  ICMJE A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Brief Summary A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Bladder Tumors
  • Neoplasms, Bladder
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: BCG
    Specified dose on specified day
    Other Name: Bacillus Calumette-Guerin
  • Drug: BMS-986205
    Specified dose on specified day
Study Arms  ICMJE
  • Experimental: Nivolumab monotherapy
    Intervention: Biological: Nivolumab
  • Experimental: Nivolumab + BCG
    Interventions:
    • Biological: Nivolumab
    • Biological: BCG
  • Experimental: Nivolumab + BMS-986205
    Interventions:
    • Biological: Nivolumab
    • Drug: BMS-986205
  • Experimental: Nivolumab + BMS-986205 + BCG
    Interventions:
    • Biological: Nivolumab
    • Biological: BCG
    • Drug: BMS-986205
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
436
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 3, 2023
Estimated Primary Completion Date January 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta high-grade lesions
  • Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

  • Sign of locally advanced disease or metastatic bladder cancer
  • Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
  • Prior immuno-oncology therapy

Other protocol defined inclusion/exclusion criteria could 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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Chile,   China,   France,   Hong Kong,   Italy,   Mexico,   Netherlands,   Russian Federation,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03519256
Other Study ID Numbers  ICMJE CA209-9UT
2017-003581-27 ( 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
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2019

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