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A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04567615
Collaborator
(none)
250
Enrollment
75
Locations
3
Arms
56.8
Anticipated Duration (Months)
3.3
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 effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: Relatlimab
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
Actual Study Start Date :
Feb 4, 2021
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A : Nivolumab

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

    		•
    Experimental: Arm B : Nivolumab + Relatlimab Dose 1

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

    • Biological: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986016

    		•
    Experimental: Arm C : Nivolumab + Relatlimab Dose 2

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

    • Biological: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986016

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Up to approximately 2 years]

    Secondary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to approximately 2.5 years]

    2. Incidence of Serious Adverse Events (SAEs) [Up to approximately 2.5 years]

    3. Incidence of AEs leading to discontinuation [Up to approximately 2.5 years]

    4. Incidence of death [Up to approximately 2.5 years]

    5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to approximately 2.5 years]

    6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to approximately 2.5 years]

    7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to approximately 2.5 years]

    8. Disease control rate (DCR) assessed by BICR per RECIST v1.1 [Up to 2 years until progression of disease]

    9. Duration of response (DOR) assessed by BICR per RECIST v1.1 [Up to 2 years after first dose of treatment]

    10. Progression-free survival assessed by BICR per RECIST v1.1 [Up to 2 years after first dose of treatment]

    11. ORR assessed by investigator per RECIST v1.1 [Up to 2 years after first dose of treatment]

    12. DCR assessed by investigator per RECIST v1.1 [Up to 2 years after first dose of treatment]

    13. DOR assessed by investigator per RECIST v1.1 [Up to 2 years after first dose of treatment]

    14. PFS assessed by investigator per RECIST v1.1 [Up to 2 years after first dose of treatment]

    15. Overall survival (OS) [Up to 3 years after first dose of treatment]

    Eligibility Criteria

    Criteria

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

    • Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation

    • Must have advanced/metastatic HCC

    • Have to be immunotherapy treatment-naive in the advanced/metastatic setting

    • Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion

    • Child-Pugh score of 5 or 6

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

    Key Exclusion Criteria:

    • Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma

    • Prior organ allograft or allogeneic bone marrow transplantation

    • No uncontrolled or significant cardiovascular disease

    • No active known autoimmune disease

    • Have received one or two lines of tyrosine kinase inhibitor therapies

    • Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0010 Ciudad de Buenos Aires Buenos Aires Argentina 1181
    2 Local Institution - 0019 Buenos Aires Distrito Federal Argentina C1096AAS
    3 Local Institution - 0017 Rosario Santa FE Argentina S2000KDS
    4 Local Institution - 0063 San Miguel de Tucumán Tucuman Argentina 4000
    5 Local Institution Camperdown New South Wales Australia 2050
    6 Local Institution - 0025 Belo Horizonte Minas Gerais Brazil 30130-090
    7 Local Institution - 0060 Porto Alegre RIO Grande DO SUL Brazil 91350-200
    8 Local Institution - 0016 Barretos SAO Paulo Brazil 14784400
    9 Local Institution - 0014 Ribeirao Preto SAO Paulo Brazil 14051-140
    10 Local Institution - 0015 São Paulo SAO Paulo Brazil 01246-000
    11 Local Institution - 0024 Temuco Araucania Chile 4810469
    12 Local Institution - 0029 Santiago Metropolitana Chile 000000
    13 Local Institution - 0018 Santiago Metropolitana Chile 8420383
    14 Local Institution Harbin Heilongjiang China 150000
    15 Local Institution Changsha Hunan China 410013
    16 Local Institution - 0118 Xi'an Shaanxi China 710061
    17 Local Institution - 0108 Xi'an Shaanxi China 710126
    18 Local Institution - 0107 Shanghai Shanghai China 200032
    19 Local Institution Hangzhou Zhejiang China 310016
    20 Local Institution Barranquilla Colombia 080020
    21 Local Institution Bogota Colombia 111511
    22 Local Institution - 0048 Brno Czechia 65653
    23 Local Institution - 0047 Hradec Kralove Czechia 50005
    24 Local Institution - 0046 Prague Czechia 140 59
    25 Local Institution - 0068 Clichy France 92110
    26 Local Institution - 0105 Grenoble France 38043
    27 Local Institution - 0074 Lyon France 69004
    28 Local Institution - 0067 Pessac France 33600
    29 Local Institution - 0069 Vandoeuvre les Nancy France 54500
    30 Local Institution - 0077 Hksar Hong Kong 0
    31 Local Institution Hong Kong Hong Kong
    32 Local Institution - 0079 Shatin Hong Kong 0
    33 Local Institution - 0072 Matsuyama Ehime Japan 790-0024
    34 Local Institution - 0054 Yokohama Kanagawa Japan 232-0024
    35 Local Institution - 0076 Yokohama Kanagawa Japan 241-8515
    36 Local Institution Osakasayama Osaka Japan 589-8511
    37 Local Institution - 0075 Ishikawa Japan 920-8641
    38 Local Institution - 0071 Kyoto Japan 602-8566
    39 Local Institution - 0011 Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 05505
    40 Local Institution - 0020 Seongnam-si Korea, Republic of 13496
    41 Local Institution - 0043 Seoul Korea, Republic of 06351
    42 Local Institution - 0100 Cuauhtémoc Estado DE Mexico Mexico 06700
    43 Local Institution - 0101 San Luis Potosí SAN LUIS Potosi Mexico 78250
    44 Local Institution - 0106 Oaxaca Mexico 68020
    45 Local Institution - 0003 Auckland New Zealand 1023
    46 Local Institution - 0012 Bytom Poland 41-900
    47 Local Institution Kraków Poland 31-501
    48 Local Institution - 0009 Mysowice Poland 41-400
    49 Local Institution - 0039 Warszawa Poland 02-034
    50 Local Institution Bucuresti Romania 030171
    51 Local Institution - 0037 București Romania 022328
    52 Local Institution - 0036 Cluj Romania 400015
    53 Local Institution - 0038 Craiova Romania 200347
    54 Local Institution Suceava Romania 720237
    55 Local Institution Moscow Russian Federation 115478
    56 Local Institution Moscow Russian Federation 121205
    57 Local Institution Singapore Singapore 119082
    58 Local Institution - 0001 Singapore Singapore 169610
    59 Local Institution - 0004 Singapore Singapore 308433
    60 Local Institution - 0066 Barcelona Spain 08036
    61 Local Institution - 0073 Cordoba Spain 14004
    62 Local Institution - 0051 Madrid Spain 28009
    63 Local Institution - 0049 Madrid Spain 28041
    64 Local Institution - 0058 Pamplona Spain 31008
    65 Local Institution - 0050 San Sebastian Spain 20014
    66 Local Institution - 0041 Taichung Taiwan 40447
    67 Local Institution - 0034 Tainan Taiwan 704
    68 Local Institution - 0031 Taipei City Taiwan 100
    69 Local Institution - 0042 Taipei Taiwan 11217
    70 Local Institution - 0032 Taoyuan Taiwan 333
    71 Local Institution Ankara Turkey 060100
    72 Local Institution Ankara Turkey 06100
    73 Local Institution Edirne Turkey 22030
    74 Local Institution Istanbul Turkey 34722
    75 Local Institution Turkey Turkey 06520

    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:
    NCT04567615
    Other Study ID Numbers:
    • CA224-073
    • 2018-003151-38
    • U1111-1218-6499
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Bristol-Myers Squibb
    Hepatocellular Carcinoma
    Advanced Hepatocellular Carcinoma
    Liver Cancer
    Liver Cancer, Adult
    Liver Cell Carcinoma
    Liver Cell Carcinoma, Adult
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Liver Neoplasms
    Nivolumab

    Study Results

    No Results Posted as of Aug 15, 2022