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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)

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: NCT03519256
Recruitment Status : Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Biological: Nivolumab Biological: BCG Drug: BMS-986205 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : October 16, 2022
Estimated Study Completion Date : October 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Nivolumab monotherapy Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Nivolumab + BCG Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: BCG
Specified dose on specified days
Other Name: Bacillus Calumette-Guerin

Experimental: Nivolumab + BMS-986205 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified days

Experimental: Nivolumab + BMS-986205 + BCG Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: BCG
Specified dose on specified days
Other Name: Bacillus Calumette-Guerin

Drug: BMS-986205
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) in all treated participants [ Time Frame: Up to week 67 ]
  2. Incidence of deaths in all treated participants [ Time Frame: Up to week 67 ]
  3. Incidence of laboratory abnormalities in all treated participants [ Time Frame: Up to week 67 ]
  4. Incidence of laboratory changes from baseline in all treated participants [ Time Frame: Up to week 67 ]
  5. Incidence of anti-nivolumab antibodies [ Time Frame: Up to week 67 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
  • Participants must have CIS to be eligible.
  • 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 apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519256


Locations
Show Show 86 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03519256    
Other Study ID Numbers: CA209-9UT
2017-003581-27 ( EudraCT Number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Bladder Cancer
BCG-unresponsive
Nivolumab
Intravesical BCG
NMIBC
Non-Muscle Invasive
BMS-986205
CheckMate 9UT
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors