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RELATIVITY-098: A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05002569
Collaborator
(none)
1,050
Enrollment
175
Locations
2
Arms
49.9
Anticipated Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: Nivolumab + Relatlimab Fixed Dose Combination
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1050 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Actual Study Start Date :
Oct 19, 2021
Anticipated Primary Completion Date :
Dec 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Nivolumab Plus Relatlimab

Combination

Biological: Nivolumab + Relatlimab Fixed Dose Combination
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag

    		•
    Experimental: Arm B: Nivolumab

    Monotherapy

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence-Free Survival (RFS) time per Investigator assessment [Until recurrence, up to 59 months]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Until death, up to 96 months]

    2. Distant Metastasis-Free Survival (DMFS) time per Investigator assessment [Until distant progression, up to 96 months]

    3. Incidence of Adverse Events (AEs) [30 days from participant's last dose]

    4. Severity of AEs [30 days from participant's last dose]

    5. Incidence of Serious Adverse Events (SAEs) [30 days from participant's last dose]

    6. Severity of SAEs [30 days from participant's last dose]

    7. Incidence of AEs leading to discontinuation (DC) [30 days from participant's last dose]

    8. Severity of AEs leading to DC [30 days from participant's last dose]

    9. Incidence of immune-mediated AEs (IMAEs) [135 days from participant's last dose]

    10. Severity of IMAEs [135 days from participant's last dose]

    11. Incidence of drug related AEs [30 days from participant's last dose]

    12. Severity of drug related AEs [30 days from participant's last dose]

    13. Incidence of deaths [30 days from participant's last dose]

    14. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [30 days from participant's last dose]

    15. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [30 days from participant's last dose]

    16. Duration of Treatment on next line therapies [Until end of next-line therapy, up to 5 years]

    17. Progression-Free Survival 2 (PFS2) [Until second recurrence, up to 5 years]

    Eligibility Criteria

    Criteria

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

    • Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible

    • Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and 17 years of age must have a Lansky/Karnofsky performance score ≥ 80%

    • Complete resection must be performed within 90 days prior to randomization

    • All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization

    • Tumor tissue must be provided for biomarker analyses

    Exclusion Criteria:

    • History of ocular melanoma

    • Untreated/unresected CNS metastases or leptomeningeal metastases

    • Active, known, or suspected autoimmune disease

    • Participants with serious or uncontrolled medical disorder

    • Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted

    • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening

    • History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Birmingham Alabama United States 35233
    2 Highlands Oncology Group-Research Department Springdale Arkansas United States 72762
    3 The Angeles Clinic And Research Institute. Los Angeles California United States 90025
    4 Local Institution Palo Alto California United States 94304
    5 San Francisco Oncology Associates San Francisco California United States 94115
    6 Local Institution Aurora Colorado United States 80045
    7 Local Institution Washington District of Columbia United States 20007
    8 Local Institution Miami Florida United States 33136
    9 Local Institution Miami Florida United States 33136
    10 Sacred Heart Medical Group Pensacola Florida United States 32504
    11 Local Institution Tampa Florida United States 33612
    12 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
    13 Northside Hospital Atlanta Georgia United States 30342
    14 Northwestern Memorial Hospital Chicago Illinois United States 60611
    15 Illinois Cancercare, PC Peoria Illinois United States 61615
    16 Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana United States 46804
    17 Local Institution Iowa City Iowa United States 52242
    18 Local Institution Kansas City Kansas United States 66160
    19 Local Institution Boston Massachusetts United States 02215
    20 Local Institution Ann Arbor Michigan United States 48109
    21 Local Institution Grand Rapids Michigan United States 49503
    22 Virginia Piper Cancer Institute Minneapolis Minnesota United States 55407
    23 John Theurer Cancer Center Hackensack New Jersey United States 07601
    24 Local Institution Morristown New Jersey United States 07962
    25 NYU Langone Health-Perlmutter Cancer Center New York New York United States 10016
    26 Local Institution New York New York United States 10029
    27 Memorial Sloan Kettering Nassau New York New York United States 10065
    28 Levine Cancer Institute-Cutaneous Malignancies/Immunotherapy Charlotte North Carolina United States 28204
    29 Duke Cancer Institute Durham North Carolina United States 27710
    30 Cleveland Clinic-Taussig Cancer Center Cleveland Ohio United States 44195
    31 Local Institution Columbus Ohio United States 43221
    32 Local Institution Philadelphia Pennsylvania United States 19111
    33 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    34 Medical University Of South Carolina Charleston South Carolina United States 29425
    35 The West Clinic Germantown Tennessee United States 38138
    36 Local Institution Nashville Tennessee United States 37232-6307
    37 Local Institution Austin Texas United States 78731
    38 Local Institution Dallas Texas United States 75246
    39 University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology Houston Texas United States 77030
    40 Inova Schar Cancer Institute Fairfax Virginia United States 22031
    41 Local Institution - 0004 Córdoba Cordoba Argentina X5000HXL
    42 Local Institution - 0001 Caba Distrito Federal Argentina C1430
    43 Local Institution - 0005 Ciudad Autónoma de Buenos Aires Distrito Federal Argentina 1426
    44 Local Institution - 0002 Ciudad de Buenos Aires Distrito Federal Argentina C1121ABE
    45 Local Institution - 0003 Buenos Aires Argentina C1426ABP
    46 Local Institution - 0030 Waratah New South Wales Australia 2298
    47 Local Institution - 0252 Westmead New South Wales Australia 2145
    48 Local Institution - 0032 Wollstonecraft New South Wales Australia 2065
    49 Local Institution Tiwi Northern Territory Australia 0810
    50 Local Institution - 0028 Brisbane Queensland Australia 4102
    51 Local Institution - 0027 Southport Queensland Australia 4215
    52 Local Institution - 0250 Woodville South Australia Australia 5011
    53 Local Institution Ballarat Central Victoria Australia 3350
    54 Local Institution - 0035 Ballarat Victoria Australia 3350
    55 Local Institution - 0253 Heidelberg Victoria Australia 3084
    56 Local Institution - 0031 Melbourne Victoria Australia 3000
    57 Local Institution - 0251 Murdoch Western Australia Australia 6150
    58 Local Institution Nedlands Western Australia Australia 6009
    59 Local Institution - 0082 Graz Steiermark Austria 8036
    60 Local Institution - 0086 Salzburg Austria 5020
    61 Local Institution - 0084 Vienna Austria 1090
    62 Local Institution Brussels Belgium 1090
    63 Local Institution - 0105 Brussels Belgium 1200
    64 Local Institution - 0109 Liège Belgium 4000
    65 Local Institution - 0106 Wilrijk Belgium 2610
    66 Local Institution - 0071 Salvador Bahia Brazil 40170-070
    67 Local Institution - 0072 Fortaleza Ceara Brazil 60135237
    68 Local Institution - 0068 Vitória Espirito Santo Brazil 29055450
    69 Local Institution - 0047 Belo Horizonte Minas Gerais Brazil 30130-090
    70 Local Institution - 0056 Ijui Rio Grande Do Sul Brazil 98700-000
    71 Local Institution - 0257 Porto Alegre RIO Grande DO SUL Brazil 90035-903
    72 Local Institution Porto Alegre RIO Grande DO SUL Brazil 91350-200
    73 Local Institution - 0048 Santa Cruz do Sul RIO Grande DO SUL Brazil 96830-180
    74 Local Institution - 0070 Barretos SAO Paulo Brazil 14784400
    75 Local Institution - 0058 Rio de Janeiro Brazil 20220-410
    76 Local Institution Edmonton Alberta Canada T6G 1Z2
    77 Local Institution Vancouver British Columbia Canada V5Z 4E6
    78 Local Institution Halifax Nova Scotia Canada B3H 1V7
    79 Local Institution Toronto Ontario Canada M5G 2M9
    80 Local Institution Montreal Quebec Canada H3T 1E2
    81 Local Institution - 0159 Montréal Quebec Canada H2X 1P1
    82 Local Institution - 0160 Quebec City Quebec Canada G1J 1Z4
    83 Local Institution Sherbrooke Quebec Canada J1H 5N4
    84 Local Institution - 0013 Santiago Metropolitana Chile 7510032
    85 Local Institution - 0006 Santiago Metropolitana Chile 8420383
    86 Local Institution - 0014 Santiago Metropolitana Chile
    87 Local Institution - 0214 Beijing Beijing China 100142
    88 Local Institution - 0241 Chongqing Chongqing China 400030
    89 Local Institution - 0245 Fuzhou City Fujian China 350014
    90 Local Institution - 0217 Guangzhou Guangdong China 510060
    91 Local Institution Zhengzhou Henan China 450099
    92 Local Institution - 0237 Wuhan Hubei China 430022
    93 Local Institution - 0215 Nanjing Jiangsu China 210000
    94 Local Institution Chengdu Sichuan China 610041
    95 Local Institution Tianjin Tianjin China 300060
    96 Local Institution Urumqi Xinjiang China 830000
    97 Local Institution Hangzhou Zhejiang China 310022
    98 Local Institution - 0244 Taiyuan China 030032
    99 Local Institution - 0156 Brno Czechia 65653
    100 Local Institution - 0091 Hradec Kralove Czechia 50005
    101 Local Institution - 0026 Ostrava Czechia 708 52
    102 Local Institution - 0062 Prague Czechia 12808
    103 Local Institution - 0022 Aalborg Denmark 9100
    104 Local Institution Aarhus N Denmark 8200
    105 Local Institution - 0018 Copenhagen Denmark 2730
    106 Local Institution - 0020 Odense Denmark 5000
    107 Local Institution - 0007 Helsinki Finland 00290
    108 Local Institution - 0019 Tampere Finland 33520
    109 Local Institution - 0015 Turku Finland 20521
    110 Local Institution - 0043 Dijon France 21000
    111 Local Institution - 0044 Marseille France 13385
    112 Local Institution - 0039 Nantes France 44093
    113 Local Institution - 0042 Paris France 75010
    114 Local Institution - 0041 Pierre-Bénite France 69310
    115 Local Institution - 0046 Toulouse France 31100
    116 Local Institution - 0040 Villejuif France 94800
    117 Local Institution - 0073 Buxtehude Germany 21614
    118 Local Institution - 0077 Dresden Germany 01307
    119 Local Institution - 0074 Erlangen Germany 91054
    120 Local Institution - 0131 Essen Germany 45147
    121 Local Institution - 0081 Gera Germany 0
    122 Local Institution - 0079 Hannover Germany 30625
    123 Local Institution - 0075 Heidelberg Germany D-69120
    124 Local Institution - 0078 Lübeck Germany 23538
    125 Local Institution - 0083 Minden Germany 32429
    126 Local Institution - 0076 Munich Germany 80337
    127 Local Institution - 0092 Tübingen Germany 72076
    128 Local Institution - 0080 Wuerzburg Germany 97080
    129 Local Institution - 0114 Athens Greece 11527
    130 Local Institution - 0113 Neo Faliro Greece 185 47
    131 Local Institution - 0112 Thessaloniki Greece 540 07
    132 Local Institution - 0116 Afula Israel 1834111
    133 Local Institution - 0118 Jerusalem Israel 9112001
    134 Local Institution - 0199 Ramag Gan Israel 526200
    135 Local Institution - 0117 Ramat Gan Israel 5262100
    136 Local Institution - 0123 Milano Italy 20141
    137 Local Institution - 0115 Milan Italy 20133
    138 Local Institution - 0119 Napoli Italy 80131
    139 Local Institution - 0120 Padova Italy 35128
    140 Local Institution - 0122 Perugia Italy 06132
    141 Local Institution - 0121 Siena Italy 53100
    142 Local Institution - 0100 Benito Juarez Distrito Federal Mexico 03240
    143 Local Institution - 0021 Zapopan Jalisco Mexico 45070
    144 Local Institution - 0093 Mexico Nuevo LEON Mexico 64320
    145 Local Institution - 0098 Oaxaca Mexico 68020
    146 Local Institution - 0009 Lørenskog Akershus Norway 1478
    147 Local Institution - 0017 Oslo Norway 0310
    148 Local Institution - 0023 Stavanger Norway 4011
    149 Local Institution - 0249 Coimbra Portugal 3000-075
    150 Local Institution Lisboa Portugal 1099-023
    151 Local Institution Lisbon Portugal 1649-035
    152 Local Institution Porto Portugal 4200-018
    153 Local Institution Brasov Romania 500283
    154 Local Institution Cluj-Napoca Romania 400015
    155 Local Institution Craiova Romania 200347
    156 Local Institution Floresti/ Cluj Romania 407280
    157 Local Institution Iasi Romania 700111
    158 Local Institution - 0188 Badajoz Spain 06071
    159 Local Institution - 0201 Barcelona Spain 08035
    160 Local Institution - 0153 Granada Spain 18012
    161 Local Institution - 0150 Madrid Spain 28009
    162 Local Institution - 0151 San Sebastian Spain 20014
    163 Local Institution - 0152 València Spain 46026
    164 Local Institution - 0010 Gothenburg Sweden 41345
    165 Local Institution - 0011 Lund Sweden 221 85
    166 Local Institution - 0012 Solna Sweden 171 64
    167 Local Institution - 0085 Basel Switzerland 4031
    168 Kantonsspital Graubünden-Medizin Chur Switzerland 7000
    169 Local Institution - 0090 Zürich Switzerland 8091
    170 Local Institution - 0187 Glasgow Lanarkshire United Kingdom G12 0YN
    171 Local Institution - 0101 Nottingham Nottinghamshire United Kingdom NG5 1PB
    172 Local Institution Bristol United Kingdom BS2 8ED
    173 Local Institution - 0232 Oxford United Kingdom OX3 7LE
    174 Local Institution Southampton United Kingdom SO16 6YD
    175 Local Institution Swansea United Kingdom SA2 8QA

    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:
    NCT05002569
    Other Study ID Numbers:
    • CA224-098
    • 2021-001641-13
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 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
    Melanoma
    Relatlimab
    Nivolumab
    Opdivo
    Additional relevant MeSH terms:
    Melanoma
    Nivolumab

    Study Results

    No Results Posted as of Aug 1, 2022