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CheckMate 9UT: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03519256
Collaborator
(none)
69
Enrollment
86
Locations
4
Arms
50.5
Anticipated Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 2, 2018
Anticipated Primary Completion Date :
Oct 16, 2022
Anticipated Study Completion Date :
Oct 16, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Bacillus Calumette-Guerin

    • Drug: BMS-986205
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) in all treated participants [Up to week 67]

    2. Incidence of deaths in all treated participants [Up to week 67]

    3. Incidence of laboratory abnormalities in all treated participants [Up to week 67]

    4. Incidence of laboratory changes from baseline in all treated participants [Up to week 67]

    5. Incidence of anti-nivolumab antibodies [Up to week 67]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC Norris Comprehensive Cancer Center Los Angeles California United States 90033
    2 Local Institution - 0081 Riverside California United States 92505
    3 Moffitt Cancer Center Tampa Florida United States 33612
    4 Emory University Atlanta Georgia United States 30322
    5 The University Of Chicago Chicago Illinois United States 60637
    6 Wichita Urology Group Wichita Kansas United States 67226
    7 Local Institution - 0001 Baltimore Maryland United States 21287
    8 University Of Michigan Ann Arbor Michigan United States 48109
    9 University Of Minnesota Minneapolis Minnesota United States 55455
    10 Adult & Pediatric Urology Omaha Nebraska United States 68114
    11 Local Institution - 0144 New Brunswick New Jersey United States 08903
    12 Deleware Valley Urology, LLC Voorhees New Jersey United States 08043
    13 Laura & Isaac Perlmutter Cancer Center New York New York United States 10016
    14 James Cancer Hospital Columbus Ohio United States 43212
    15 Local Institution - 0036 Bala-Cynwyd Pennsylvania United States 19004
    16 Medical University Of South Carolina Charleston South Carolina United States 29425
    17 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    18 Local Institution Chattanooga Tennessee United States 37403
    19 Urology Clinics Of North Texas, Pa Dallas Texas United States 75231
    20 Houston Methodist Hospital Houston Texas United States 77030
    21 Local Institution Houston Texas United States 77030
    22 Local Institution Lubbock Texas United States 79415
    23 Urology San Antonio Research, Pa San Antonio Texas United States 78229
    24 Local Institution Capital Federal Buenos Aires Argentina 1426
    25 Local Institution Ciudad Autónoma de Buenos Aires Buenos Aires Argentina 1280
    26 Local Institution Ciudad Autonoma Buenos Aires Distrito Federal Argentina 1118
    27 Local Institution Viedma RIO Negro Argentina 8500
    28 Instituto Oncologico De Cordoba Cordoba Argentina 5000
    29 Local Institution Mendoza Argentina 5500
    30 Local Institution Camperdown New South Wales Australia 2050
    31 Local Institution St Leonards New South Wales Australia 2065
    32 Local Institution Fortaleza Ceara Brazil 60130-241
    33 Local Institution Curitiba Parana Brazil 80810050
    34 Local Institution - 0073 Porto Alegre RIO Grande DO SUL Brazil 91350-200
    35 Local Institution Itacorubi, Florianopolis Santa Catarina Brazil 88034
    36 Local Institution - 0078 Jau Sao Paulo Brazil 17210-120
    37 Local Institution - 0150 Rio de Janeiro Brazil 20230-130
    38 Local Institution Sao Paulo Brazil 01246-000
    39 North York General Hospital Toronto Ontario Canada M2J 1V1
    40 Local Institution Toronto Ontario Canada M4N 3M5
    41 Local Institution Toronto Ontario Canada M5G 1X6
    42 Local Institution Quebec Canada G1R 2J6
    43 Local Institution Santiago Metropolitana Chile 8420383
    44 Local Institution Santiago Metropolitana Chile
    45 Local Institution Beijing Beijing China 100021
    46 Local Institution Beijing Beijing China 100034
    47 Local Institution - 0116 Beijing Beijing China 100142
    48 Local Institution Beijing Beijing China 100191
    49 Local Institution Chongqing Chongqing China 400030
    50 Local Institution Fuzhou Fujian China 350001
    51 Local Institution Guangzhou Guangdong China 510080
    52 Local Institution Nanjing Jiangsu China 210008
    53 Local Institution Nanchang Jiangxi China
    54 Local Institution Jinan Shandong China 250012
    55 Local Institution Yantai Shandong China 264000
    56 Local Institution Shanghai Shanghai China 200025
    57 Local Institution - 0094 Shanghai Shanghai China 200032
    58 Local Institution Shanghai Shanghai China 200040
    59 Local Institution Chengdu Sichuan China 610041
    60 Local Institution Tianjin Tianjin China 300211
    61 Local Institution Hang'zhou Zhejiang China 310000
    62 Chu Angers Angers France 49100
    63 Hopital Pellegrin Bordeaux France 33000
    64 Hopital Claude Huriez LILLE Cedex France 59037
    65 Nouvel Hopital Civil Chru De Strasbourg Strasbourg Cedex France 67091
    66 Hopital Foch Suresnes France 92151
    67 Local Institution Hong Kong Hong Kong
    68 IRCCS Istituto Nazionale Tumori Milano Milano Italy 20133
    69 Instituto Nazionale Tumori Fondazione G. Pascale Napoli Italy 80131
    70 Azienda Ospedaliera Universitaria Pisana Pisa Italy 56126
    71 Centro De Estudios Y Prevencion Del Cancer A. C. Tuxtla Gutierrez Chiapas Mexico 290838
    72 Cryptex Investigacion Clinica Sa de Cv Ciudad de Mexico Distrito Federal Mexico 06100
    73 Local Institution Amsterdam Netherlands 1066 CX
    74 Local Institution Nijmegen Netherlands 6525 GA
    75 Local Institution Utrecht Netherlands 3584CX
    76 Local Institution Omsk Russian Federation 644013
    77 Local Institution Saint-Petersburg Russian Federation 194044
    78 Local Institution Saint-Petersburg Russian Federation 199034
    79 Local Institution Madrid Spain 28041
    80 Local Institution Malaga Spain 29010
    81 Local Institution Santander Spain 39008
    82 Local Institution Valencia Spain 46010
    83 Local Institution Chelmsford Essex United Kingdom CM1 7ET
    84 Local Institution London Greater London United Kingdom N18 1QX
    85 Local Institution - 0013 Southampton Hampshire United Kingdom SO16 6YD
    86 Local Institution Lancaster United Kingdom LA1 4RP

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03519256
    Other Study ID Numbers:
    • CA209-9UT
    • 2017-003581-27
    First Posted:
    May 8, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    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:
    Urinary Bladder Neoplasms
    Nivolumab
    Linrodostat

    Study Results

    No Results Posted as of Jun 30, 2022