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RELATIVITY-127: A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05625399
Collaborator
(none)
814
Enrollment
85
Locations
2
Arms
24.9
Anticipated Duration (Months)
9.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
814 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab + Relatlimab FDC SC

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-986213

    • Drug: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986213

    		•
    Active Comparator: Nivolumab + Relatlimab FDC IV

    Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • BMS-986213

    • Drug: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986213

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab [Up to 28 days]

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

    3. Cavgd28 of Relatlimab [Up to 28 days]

    4. Cminss of Relatlimab [Up to 4 months]

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1 [Up to approximately 3 years]

    2. Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab [Up to 28 days]

    3. Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab [Up to 28 days]

    4. Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab [Up to 28 days]

    5. Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab [Up to 4 months]

    6. Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab [Up to 4 months]

    7. Duration of Response (DOR) by BICR per RECIST v1.1 [Up to approximately 3 years]

    8. Disease Control Rate (DCR) by BICR per RECIST v1.1 [Up to approximately 3 years]

    9. Time to Response (TTR), by BICR per RECIST v1.1 [Up to approximately 3 years]

    10. Objective Response Rate (ORR) by Investigator per RECIST v1.1 [Up to approximately 3 years]

    11. DOR by Investigator per RECIST v1.1 [Up to approximately 3 years]

    12. DCR by Investigator per RECIST v1.1 [Up to approximately 3 years]

    13. TTR by Investigator per RECIST v1.1 [Up to approximately 3 years]

    14. Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1 [Up to approximately 3 years]

    15. Overall Survival [Up to approximately 3 years]

    16. Number of Participants with Adverse Events (AEs) [Up to approximately 3 years]

    17. Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS) [Up to approximately 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).

    • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.

    • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    • Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).

    • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

    Exclusion Criteria:

    • Participants must not have ocular melanoma.

    • Participants must not have a history of myocarditis, regardless of etiology.

    • Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dignity Health - St. Josephs Hospital and Medical Center Phoenix Arizona United States 85013
    2 Stanford Univ Med School Dept of Dermatology Stanford California United States 94305
    3 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
    4 Ft. Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46804
    5 Greenebaum Cancer Center University of Maryland Baltimore Maryland United States 21201
    6 Oncology Hematology West P.C. dba Nebraska Cancer Specialist Omaha Nebraska United States 68130
    7 Rutgers CINJ New Brunswick New Jersey United States 08901
    8 St. Lukes University Health Network Easton Pennsylvania United States 18045
    9 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    10 Intermountain Medical Center Campus Location Murray Utah United States 84107
    11 Local Institution - 0042 Caba Buenos Aires Argentina 1125
    12 Local Institution - 0133 Ciudad Autonoma de Buenos Aires Buenos Aires Argentina 1426
    13 Local Institution - 0145 Caba Ciudad Autonoma De Buenos Aires Argentina 1430
    14 Local Institution - 0160 Rosario Santa Fe Argentina 2000
    15 Local Institution - 0067 Buenos Aires Argentina C1121AE
    16 Local Institution - 0118 Wagga Wagga New South Wales Australia 2650
    17 Local Institution - 0033 Westmead New South Wales Australia 2145
    18 Local Institution - 0008 Bendigo Victoria Australia 3550
    19 Local Institution - 0154 Heidelberg Victoria Australia 3084
    20 Local Institution - 0030 Prahran Victoria Australia 3004
    21 Local Institution - 0161 Nedlands Western Australia Australia 6009
    22 Local Institution - 0027 Graz Austria 8036
    23 Local Institution - 0078 Charleroi Hainaut Belgium 6000
    24 Local Institution - 0147 Curitiba Parana Brazil 80520-174
    25 Local Institution - 0025 Ijui Rio Grande Do Sul Brazil 98700-000
    26 Local Institution - 0132 Florianopolis Santa Catarina Brazil 88034-000
    27 Local Institution - 0018 Sao Jose do Rio Preto Sao Paulo Brazil 15090-000
    28 Local Institution - 0159 Blumenau SC Brazil 89010-340
    29 Local Institution - 0130 Sao Paulo Brazil 01321-001
    30 Local Institution - 0141 Calgary Alberta Canada T2N 4N2
    31 Local Institution - 0121 Hamilton Ontario Canada L8V 5C2
    32 Local Institution - 0143 Temuco Araucania Chile 4800827
    33 Local Institution - 0140 Recoleta Metropolitana Chile 8380455
    34 Local Institution - 0144 Santiago Metropolitana Chile 0101010
    35 Local Institution - 0142 Vitacura Metropolitana Chile JC5G 2Q
    36 Local Institution - 0119 Santiago de Chile Providencia Chile 7500653
    37 Local Institution - 0152 Bogota Colombia 111511
    38 Local Institution - 0149 Medellin Colombia 50030
    39 Local Institution - 0150 Valledupar Colombia 200005
    40 Local Institution - 0164 Helsinki Finland 00029
    41 Local Institution - 0162 Turku Finland 20521
    42 Local Institution - 0108 Toulouse Haute Garonne France 31059
    43 Local Institution - 0034 Paris Ile De France France 75475
    44 Local Institution - 0127 Chambray-les-Tours Indre-Et-Loire France 37044
    45 Local Institution - 0111 Lille Nord France 59000
    46 Local Institution - 0061 Villejuif Cedex Val-De-Marne France 94805
    47 Local Institution - 0128 Bayonne France 64100
    48 Local Institution - 0129 Clermont Ferrand France 63003
    49 Local Institution - 0046 Dijon France 21000
    50 Local Institution - 0052 Pierre-Benite France 69310
    51 Local Institution - 0101 Heidelberg Baden-Württemberg Germany 69120
    52 Local Institution - 0079 Ulm Baden-Württemberg Germany 89081
    53 Local Institution - 0011 Regensburg Bayern Germany 93042
    54 Local Institution - 0038 Buxtehude Niedersachsen Germany 21614
    55 Local Institution - 0137 Ludwigshafen A. Rhein Rheinland-Pfalz Germany 67063
    56 Local Institution - 0003 Luebeck Schleswig-Holstein Germany 23538
    57 Local Institution - 0136 Dortmund Germany 44137
    58 Local Institution - 0166 Frankfurt Germany 60590
    59 Local Institution - 0135 Goettingen Germany 37075
    60 Local Institution - 0138 Hamburg Germany 20251
    61 Local Institution - 0148 Koeln Germany 50937
    62 Local Institution - 0165 Marburg Germany 35043
    63 Local Institution - 0081 Tuebingen Germany 72076
    64 Local Institution - 0026 Afula North Israel 1834111
    65 Local Institution - 0054 Jerusalem Israel 91120
    66 Local Institution - 0051 Bari Italy 70124
    67 Local Institution - 0077 Genova Italy 16132
    68 Local Institution - 0084 Napoli Italy 80131
    69 Local Institution - 0104 Monterrey Nuevo Leon Mexico 64460
    70 Local Institution - 0131 Puebla Mexico 72424
    71 Local Institution - 0158 Lørenskog Kristiansand Norway 1478
    72 Local Institution - 0163 Bodo Norway 8092
    73 Local Institution - 0156 Kalnes Norway 1714
    74 Local Institution - 0155 Oslo Norway 0379
    75 Local Institution - 0005 Opole Opolskie Poland 45-061
    76 Local Institution - 0021 Krakow Poland 30-510
    77 Local Institution - 0086 A Coruna A Coruña Spain 15006
    78 Local Institution - 0012 Donostia Gipuzkoa Spain 20014
    79 Local Institution - 0134 Badalona Spain 08916
    80 Local Institution - 0126 Madrid Spain 28009
    81 Local Institution - 0151 Valencia Spain 46014
    82 Local Institution - 0062 Solna Stockholm Sweden 171 64
    83 Local Institution - 0157 Linkoeping Vastergotland Sweden 58185
    84 Local Institution - 0069 Uppsala Sweden 751 85
    85 Local Institution - 0120 Newcastle upon Tyne Northumberland United Kingdom NE7 7DN

    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:
    NCT05625399
    Other Study ID Numbers:
    • CA224-127
    • 2022-000575-39
    • U1111-1274-0193
    First Posted:
    Nov 22, 2022
    Last Update Posted:
    Feb 1, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Nivolumab
    Relatlimab
    FDC
    Melanoma
    rHuPH20
    OPDUALAG
    Additional relevant MeSH terms:
    Melanoma
    Nivolumab

    Study Results

    No Results Posted as of Feb 1, 2023