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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

  • Clinicaltrials.gov identifier

    NCT04567615

  • Recruitment Status

    Recruiting

  • First Posted

    September 28, 2020

  • Last update posted

    May 13, 2022

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:Hepatocellular Carcinoma
    Hepatoma
    Liver Cancer, Adult
    Liver Cell Carcinoma
    Liver Cell Carcinoma, Adult
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Relatlimab
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: February 2021
  • Estimated Primary Completion Date: December 2025
  • Estimated Study Completion Date: June 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A : Nivolumab
Biological: Nivolumab
Specified dose on specified days
Experimental: Arm B : Nivolumab + Relatlimab Dose 1
Biological: Nivolumab
Specified dose on specified days

Biological: Relatlimab
Specified dose on specified days
Experimental: Arm C : Nivolumab + Relatlimab Dose 2
Biological: Nivolumab
Specified dose on specified days

Biological: Relatlimab
Specified dose on specified days

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 [ Time Frame: Up to approximately 2 years ]
  • Secondary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2.5 years ]
  • 3. Incidence of AEs leading to discontinuation [ Time Frame: Up to approximately 2.5 years ]
  • 4. Incidence of death [ Time Frame: Up to approximately 2.5 years ]
  • 5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to approximately 2.5 years ]
  • 6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to approximately 2.5 years ]
  • 7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to approximately 2.5 years ]
  • 8. Disease control rate (DCR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years until progression of disease ]
  • 9. Duration of response (DOR) assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 10. Progression-free survival assessed by BICR per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 11. ORR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 12. DCR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 13. DOR assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 14. PFS assessed by investigator per RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 15. Overall survival (OS) [ Time Frame: Up to 3 years after first dose of treatment ]
  • 16. Dose: participant's actual dose as treated [ Time Frame: Up to 8 weeks ]
  • 17. Response: participant's best overall response (BOR) assessed by BICR using RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]
  • 18. LAG-3 expression by Immunohistochemistry (IHC): participant's actual LAG-3 expression value dichotomized into ≥ 1% and < 1% [ Time Frame: Up to 1 month ]
  • 19. Response: participant's BOR assessed by BICR using RECIST v1.1 [ Time Frame: Up to 2 years after first dose of treatment ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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; no prior immunotherapies are permitted 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 Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

Argentina, Distrito Federal
Local Institution - 0019
Buenos Aires

Argentina, Distrito Federal
Local Institution
Ciudad Autónoma de Buenos Aires

Argentina, Santa FE
Local Institution - 0017
Rosario

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Australia, New South Wales
Local Institution
Camperdown

Brazil, Minas Gerais
Local Institution
Belo Horizonte MG

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution - 0016
Barretos

Brazil, SAO Paulo
Local Institution - 0014
Ribeirao Preto

Brazil, SAO Paulo
Local Institution - 0015
São Paulo

Chile, Araucania
Local Institution - 0024
Temuco

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution - 0018
Santiago

China, Heilongjiang
Local Institution
Harbin

China, Hunan
Local Institution
Changsha

China, Shan3xi
Local Institution
Xi'an

China, Shan3xi
Local Institution
Xi'an

China, Shanghai
Local Institution
Shanghai

China, Zhejiang
Local Institution
Hangzhou

Colombia
Local Institution
Barranquilla

Colombia
Local Institution
Bogota

Czechia
Local Institution - 0048
Brno

Czechia
Local Institution - 0047
Hradec Kralove

Czechia
Local Institution - 0046
Prague

France
Local Institution - 0068
Clichy

France
Local Institution
Grenoble

France
Hopital De La Croix Rousse
Lyon

France
Local Institution - 0067
Pessac

France
Local Institution - 0069
Vandoeuvre les Nancy

Hong Kong
Local Institution - 0077
Hksar

Hong Kong
Local Institution
Hong Kong

Hong Kong
Local Institution
Hong Kong

Japan, Ehime
Local Institution
Matsuyama-shi

Japan, Kanagawa
Local Institution
Yokohama

Japan, Kanagawa
Local Institution - 0076
Yokohama

Japan, Osaka
Local Institution
Osakasayama

Japan
Local Institution - 0075
Ishikawa

Japan
Local Institution - 0071
Kyoto

Korea, Republic of
Local Institution - 0020
Seongnam-si

Korea, Republic of
Local Institution - 0011
Seoul

Korea, Republic of
Local Institution - 0043
Seoul

Mexico, Estado DE Mexico
Local Institution - 0100
Cuauhtémoc

Mexico, SAN LUIS Potosi
Local Institution - 0101
San Luis Potosí

Mexico
Local Institution - 0106
Oaxaca

New Zealand
Local Institution
Auckland

Poland
Local Institution
Bytom

Poland
Local Institution
Kraków

Poland
Local Institution
Myslowice

Poland
Local Institution - 0039
Warszawa

Romania
Local Institution
Bucuresti

Romania
Local Institution
București

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Romania
Local Institution
Suceava

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Singapore
Local Institution
Singapore

Singapore
Local Institution - 0001
Singapore

Singapore
Local Institution - 0004
Singapore

Spain
Local Institution - 0066
Barcelona

Spain
Local Institution - 0073
Cordoba

Spain
Local Institution - 0051
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution - 0058
Pamplona

Spain
Local Institution - 0050
San Sebastian

Taiwan
Local Institution - 0041
Taichung

Taiwan
Local Institution - 0034
Tainan

Taiwan
Local Institution
Taipei City

Taiwan
Local Institution - 0042
Taipei

Taiwan
Local Institution - 0032
Taoyuan

Turkey
Local Institution
Ankara

Turkey
Local Institution
Ankara

Turkey
Local Institution
Edirne

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Turkey

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04567615 History of Changes
  • Other Study ID Numbers: CA224-073, 2018-003151-38, U1111-1218-6499
  • First Posted: September 28, 2020 Key Record Dates
  • Last Update Posted: May 13, 2022
  • Last Verified: May 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
    Neoplasms, Glandular and Epithelial
    Neoplasms by Histologic Type
    Neoplasms
    Adenocarcinoma
    Digestive System Neoplasms
    Neoplasms by Site
    Digestive System Diseases
    Liver Diseases