Clincosm LogoSign in Get a demo

CheckMate-67T: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04810078
Collaborator
(none)
454
Enrollment
105
Locations
2
Arms
56.2
Anticipated Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab and rHuPH20
  • Biological: Nivolumab
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
454 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
Actual Study Start Date :
May 24, 2021
Anticipated Primary Completion Date :
Dec 14, 2023
Anticipated Study Completion Date :
Jan 29, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Subcutaneous Nivolumab

Biological: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298

    		•
    Active Comparator: Arm B: Intravenous Nivolumab

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time-averaged serum concentration over 28 days (Cavgd28) [Up to 28 days]

    2. Trough serum concentration at steady-state (Cminss) [Up to 4 months]

    Secondary Outcome Measures

    1. Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up [Up to 2 years 6 months]

    2. Trough serum concentration at day 28 (Cmind28) [At 28 days]

    3. Maximum serum concentration after the first dose (Cmax1) [Up to 7 days]

    4. Time to peak serum concentration after the first dose (Tmax1) [Up to 7 days]

    5. Peak serum concentration at steady-state (Cmaxss) [Up to 4 months]

    6. Steady-state average serum concentration (Cavgss) [Up to 4 months]

    7. Incidence of adverse events (AEs) [Up to 2 years 3 months]

    8. Incidence of serious adverse events (SAEs) [Up to 2 years 3 months]

    9. Incidence of AEs leading to discontinuation [Up to 2 years]

    10. Incidence of deaths [Up to 5 years]

    11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 2 years 3 months]

    12. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [Up to 2 years 3 months]

    13. Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up [Up to 2 years 6 months]

    14. Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up [Up to 3 years]

    15. Efficacy parameters: DCR by BICR at end of study [Up to 5 years]

    16. Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up [Up to 2 years 6 months]

    17. Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up [Up to 3 years]

    18. Efficacy parameters: DOR by BICR at end of study [Up to 5 years]

    19. Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up [Up to 2 years 6 months]

    20. Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up [Up to 3 years]

    21. Efficacy parameters: TTR by BICR at end of study [Up to 5 years]

    22. Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up [Up to 2 years 6 months]

    23. Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up [Up to 3 years]

    24. Efficacy parameters: PFS by BICR at end of study [Up to 5 years]

    25. Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up [Up to 2 years 6 months]

    26. Efficacy parameters: OS with a minimum of 12 months follow-up [Up to 3 years]

    27. Efficacy parameters: OS at end of study [Up to 5 years]

    28. Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up [Up to 3 years]

    29. Efficacy parameters: ORR by BICR at end of study [Up to 5 years]

    30. Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions [Up to 2 years 3 months]

    31. Incidence of local injection- or infusion-site reactions [Up to 2 years 3 months]

    32. Percentage of participants who develop anti-nivolumab antibodies, if applicable [Up to 2 years 3 months]

    33. Percentage of participants who develop neutralizing antibodies, if applicable [Up to 2 years 3 months]

    Eligibility Criteria

    Criteria

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

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

    Inclusion Criteria:

    • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features

    • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)

    • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization

    • Received no more than 2 prior systemic treatment regimens

    • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization on the study

    • Karnofsky PS ≥ 70 at screening

    • Must agree to follow specific methods of contraception, if applicable

    Exclusion Criteria:

    • Untreated, symptomatic central nervous system (CNS) metastases

    • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization

    • Active, known, or suspected autoimmune disease

    • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current

    CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization

    2. They continue on ART as clinically indicated while enrolled on study

    3. CD4 counts and viral load are monitored per standard of care by a local health care provider

    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally

    • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible

    • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

    • Treatment with any live attenuated vaccine within 30 days of first study treatment

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Chicago Illinois United States 60611
    2 Roswell Park Cancer Institute Buffalo New York United States 14263
    3 Reading Hospital McGlinn Cancer Institute West Reading Pennsylvania United States 19611
    4 Local Institution - 0038 Ciudad Autonoma de BuenosAires Buenos Aires Argentina C1426ANZ
    5 Local Institution - 0058 Mar Del Plata Buenos Aires Argentina B7600FZO
    6 Centro de Investigacion Pergamino S.A. Pergamino Buenos Aires Argentina 2700
    7 Local Institution - 0030 Rio Cuarto Cordoba Argentina 5800
    8 Centro de Investigaciones Clinicas. Clinica Viedma S.A. Viedma RIO Negro Argentina 8500
    9 Local Institution - 0095 Buenos Aires Argentina C1419AHN
    10 Local Institution - 0079 Cordoba Argentina X5002HWE
    11 Local Institution - 0056 San Juan Argentina J5402DIL
    12 Local Institution - 0064 Curitiba Parana Brazil 80520-174
    13 Local Institution Ijui RIO Grande DO SUL Brazil 98700-000
    14 Local Institution Ijui RIO Grande DO SUL Brazil 98700-000
    15 Local Institution Porto Alegre RIO Grande DO SUL Brazil 91350-200
    16 Local Institution Barretos SAO Paulo Brazil 14784-400
    17 Local Institution Sao Jose Do Rio Preto SAO Paulo Brazil 15090-000
    18 Local Institution Rio de Janeiro Brazil 20230-130
    19 Local Institution Sao Paulo Brazil 01246-000
    20 Local Institution Sao Paulo Brazil 01327-001
    21 Local Institution - 0084 Temuco Araucania Chile 0
    22 Local Institution - 0005 Santiago de Chile Metropolitana Chile 0
    23 Local Institution - 0104 Santiago de Chile Metropolitana Chile 7500653
    24 Local Institution - 0076 Santiago Metropolitana Chile 7500921
    25 Local Institution - 0077 Vina del Mar Valparaiso Chile 2520598
    26 Local Institution - 0063 Brno Czechia 65653
    27 Local Institution - 0036 Hradec Kralove Czechia 500 05
    28 Local Institution - 0020 Olomouc Czechia 779 00
    29 Fakultni nemocnice Ostrava Ostrava Czechia 708 52
    30 Local Institution - 0010 Prague Czechia 140 59
    31 Fakultna nemocnice Bulovka Praha Czechia 180 81
    32 Local Institution Jyvaskyla Finland 40620
    33 Local Institution - 0080 Kuopio Finland 70029
    34 Local Institution - 0017 Tampere Finland 33521
    35 Local Institution Turku Finland FIN-20520
    36 Local Institution Lyon France 69373 CEDEX 08
    37 Local Institution Nice cedex 2 France 6189
    38 Local Institution - 0051 Suresnes France 92151
    39 Local Institution Toulouse France 31059
    40 Local Institution - 0068 Villejuif France 94805
    41 Local Institution Cork Ireland 1111
    42 Local Institution Dublin Ireland 9
    43 Local Institution - 0060 Dublin Ireland D24 NR01
    44 ASST Istituti Ospitalieri, Oncology Department Cremona Italy 26100
    45 Local Institution - 0008 Firenze Italy 50134
    46 Local Institution - 0027 Meldola Italy 47014
    47 Local Institution Milano Italy 20133
    48 Local Institution - 0018 Milano Italy 20141
    49 Local Institution - 0014 Padova Italy 35128
    50 Local Institution - 0082 Parma Italy 43126
    51 Local Institution Pavia Italy 27100
    52 Local Institution Pisa Italy 56126
    53 Local Institution Roma Italy 168
    54 Local Institution Rome Italy 00152
    55 Local Institution - 0057 Terni Italy 05100
    56 Local Institution - 0101 Torreon Coahuila Mexico 27010
    57 Local Institution - 0089 Tlalpan Distrito Federal Mexico 14080
    58 Local Institution Monterrey Nuevo LEON Mexico 64460
    59 Local Institution - 0031 Monterrey Nuevo LEON Mexico 64710
    60 Local Institution Queretaro Mexico 76000
    61 Local Institution - 0085 Queretaro Mexico 76090
    62 Local Institution - 0105 San Luis Potosi Mexico 78200
    63 Local Institution - 0053 Auckland New Zealand 1023
    64 Local Institution - 0041 Hamilton New Zealand 3204
    65 Local Institution - 0078 Palmerston North New Zealand 4414
    66 Local Institution - 0055 Biala Podlaska Poland 21-500
    67 Local Institution - 0062 Bydgoszcz Poland 85-796
    68 Local Institution - 0083 Gdansk Poland 80-214
    69 Local Institution Gliwice Poland 44-101
    70 Local Institution - 0021 Krakow Poland 30-688
    71 Local Institution Krakow Poland 31-115
    72 Local Institution - 0001 Poznan Poland 60-569
    73 Local Institution - 0023 Warszawa Poland 02-781
    74 Instituto Portugues de Oncologia de Coimbra Francisco Gentil EPE Coimbra Portugal 3030-075
    75 Local Institution - 0052 Lisboa Portugal 1500-650
    76 Local Institution Bucuresti Romania 22238
    77 Local Institution Cluj-Napoca Romania 400132
    78 Local Institution Cluj-Napoca Romania 400641
    79 Local Institution Craiova Romania 200347
    80 SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine Chelyabinsk Russian Federation 454087
    81 Ivanovo Regional Oncology Dispensary Ivanovo Russian Federation 153040
    82 Local Institution Moscow Russian Federation 115478
    83 Local Institution Moscow Russian Federation 117997
    84 Local Institution Moscow Russian Federation 121309
    85 Local Institution Moscow Russian Federation 121359
    86 Hertzen Moscow Oncology Research Center Moscow Russian Federation 125284
    87 Local Institution Nizghiy Novgorod Russian Federation 603000
    88 Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary Omsk Russian Federation 644013
    89 LLC Eurocityclinic Saint Petersburg Russian Federation 197022
    90 Local Institution - 0048 Barcelona Spain 08003
    91 Local Institution - 0102 Barcelona Spain 08035
    92 Local Institution Barcelona Spain 08041
    93 Local Institution - 0072 Madrid Spain 28026
    94 MD Anderson Cancer Center Madrid Madrid Spain 28033
    95 Local Institution - 0074 Madrid Spain 28046
    96 HM Universitario Sanchinarro - CIOCC Madrid Spain 28050
    97 Local Institution - 0032 Sabadell Spain 08208
    98 Hospital Marques de Valdecilla Santander Spain 39008
    99 Local Institution - 0059 Sevilla Spain 41013
    100 Local Institution Adana Turkey 1123
    101 Local Institution Ankara Turkey 06230
    102 Local Institution Ankara Turkey 6590
    103 Local Institution Istanbul Turkey 34098
    104 Local Institution Istanbul Turkey 34214
    105 Local Institution Izmir Turkey 111

    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:
    NCT04810078
    Other Study ID Numbers:
    • CA209-67T
    • 2020-003655-15
    • U1111-1255-9514
    First Posted:
    Mar 22, 2021
    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
    BMS-936558
    BMS-986298
    Clear cell renal cell carcinoma
    ccRCC
    Nivolumab
    Opdivo
    rHuPH20
    Subcutaneous
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Nivolumab

    Study Results

    No Results Posted as of Jun 30, 2022