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Trial record 1 of 1 for:    NCT03519256
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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 : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 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 : January 4, 2022
Estimated Study Completion Date : April 16, 2023

Resource links provided by the National Library of Medicine

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

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




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 ]
  3. Event Free Survival (EFS), per PRC, for all non-CIS participants [ 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 ]


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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, 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


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
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 #.

  Show 75 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03519256     History of Changes
Other Study ID Numbers: CA209-9UT
2017-003581-27 ( EudraCT Number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs