A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (RELATIVITY-106)

January 9, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2
  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0045
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0022
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0026
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0013
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0017
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0025
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0009
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0064
    • Shan3xi
      • Xi'an, Shan3xi, China, 710700
        • Local Institution - 0066
  • France
      • Grenoble, France, 38043
        • Local Institution - 0012
      • Nice, France, 06202
        • Local Institution - 0001
      • Reims, France, 51092
        • Local Institution - 0002
      • Rennes, France, 35042
        • Local Institution - 0008
      • Suresnes, France, 92151
        • Local Institution - 0054
    • Cedex 9
      • Avignon, Cedex 9, France, 84918
        • Local Institution - 0021
  • Germany
      • Frankfurt, Germany, 60590
        • Local Institution - 0035
      • Mainz, Germany, 55131
        • Local Institution - 0057
      • Munich, Germany, 81377
        • Local Institution - 0055
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Local Institution - 0051
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0004
      • Shatin, Hong Kong, 999077
        • Local Institution - 0031
  • Italy
      • Milan, Italy, 20122
        • Local Institution - 0036
      • Padua, Italy, 35128
        • Local Institution - 0003
      • Roma, Italy, 00168
        • Local Institution - 0010
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0047
    • Ehime
      • Matsuyama, Ehime, Japan, 7900024
        • Local Institution - 0048
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 9208641
        • Local Institution - 0058
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2320024
        • Local Institution - 0050
    • Osaka
      • Sayama, Osaka, Japan, 5898511
        • Local Institution - 0041
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution - 0063
  • Poland
      • Gdansk, Poland, 80-219
        • Local Institution - 0023
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Local Institution - 0028
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-034
        • Local Institution - 0016
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0019
    • PR
      • Rio Piedras, PR, Puerto Rico, 935
        • Local Institution - 0052
  • Singapore
      • Singapore, Singapore, 168583
        • Local Institution - 0029
      • Singapore, Singapore, 217562
        • Local Institution - 0027
      • Singapore, Singapore, 308433
        • Local Institution - 0018
      • Singapore, Singapore, 329563
        • Local Institution - 0044
  • South Korea
      • Seoul, South Korea, 138-736
        • Local Institution - 0056
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13496
        • Local Institution - 0037
  • Spain
      • Madrid, Spain, 28046
        • Local Institution - 0053
      • Pamplona, Spain, 31008
        • Local Institution - 0038
      • Zaragoza, Spain, 50009
        • Local Institution - 0040
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Local Institution - 0032
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0007
    • Sede Madrid
      • Madrid, Sede Madrid, Spain, 28027
        • Local Institution - 0067
  • Taiwan
      • Taichung, Taiwan, 40705
        • Local Institution - 0024
      • Taipei, Taiwan, 10048
        • Local Institution - 0046
      • Taipei, Taiwan, 11217
        • Local Institution - 0049
    • Tai Zhong Shi
      • District Taichung City, Tai Zhong Shi, Taiwan, 404
        • Local Institution - 0043
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0042
      • Los Angeles, California, United States, 90095
        • Local Institution - 0039
      • San Francisco, California, United States, 94115
        • Local Institution - 0034
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Local Institution - 0030
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Local Institution - 0059
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0060
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0065
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0061
      • The Bronx, New York, United States, 10461
        • Local Institution - 0062
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution - 0033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
  • Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
  • Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Prior allogenic stem cell or solid organ transplantation
  • Untreated symptomatic central nervous system (CNS) metastases

  • Clinically significant ascites as defined by:

    i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • Avastin
Drug: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016
Experimental: Arm B: Placebo + Nivolumab + Bevacizumab
Other: Placebo
Specified dose on specified days
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Bevacizumab
Specified dose on specified days
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to 6 weeks
Up to 6 weeks
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Assessed up to 3 years
Assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 135 days after participant's last dose
Up to 135 days after participant's last dose
ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
Time Frame: Assessed up to 3 years
Assessed up to 3 years
Overall Survival (OS) of all randomized participants
Time Frame: Assessed up to 3 years
Assessed up to 3 years
OS of all randomized participants that are LAG-3 positive
Time Frame: Assessed up to 3 years
Assessed up to 3 years
Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive
Time Frame: Assessed up to 3 years
Assessed up to 3 years
PFS by BICR per RECIST v1.1 in all randomized participants
Time Frame: Assessed up to 3 years
Assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

July 5, 2025

Study Completion (Actual)

November 18, 2025

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-106
  • 2021-003606-53 (EudraCT Number)
  • U1111-1267-1579 (Other Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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