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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519256
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 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 : May 25, 2018
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : September 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab monotherapy Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Nivolumab + BCG Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Biological: BCG
Specified dose on specified day
Other Name: Bacillus Calumette-Guerin
Experimental: Nivolumab + BMS-986205 Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified day
Experimental: Nivolumab + BMS-986205 + BCG 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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC) [ Time Frame: Up to 5 years ]
  2. Duration of complete response (DOCR), per PRC, in CIS participants with CR [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
  2. Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 months ]
  3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 15 months ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 15 months ]
  5. Incidence of deaths [ Time Frame: Up to 5 years ]
  6. Incidence of laboratory abnormalities [ Time Frame: Up to 15 months ]

Eligibility Criteria
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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

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

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 could apply

Contacts and Locations
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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


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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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: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
Antineoplastic Agents, Immunological
Antineoplastic Agents