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

March 7, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

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 Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0V9
        • Recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
          • Eric Chen, Site 0009
          • Phone Number: 14169464467
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Yabing Guo, Site 0064
          • Phone Number: 862061641945
    • Shan3xi
      • Xian, Shan3xi, China, 710700
        • Recruiting
        • Xian International Medical Center Hospital
        • Contact:
          • Guohong Han, Site 0066
          • Phone Number: +8613991969930
  • France
      • Bondy, France, 93140
        • Not yet recruiting
        • Local Institution
        • Contact:
          • Site 0011
      • Grenoble, France, 38043
        • Recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Nice, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice Hopital l Archet (Albert Tran)
        • Contact:
          • Albert Tran, Site 0001
          • Phone Number: 04 92 03 59 43
      • Reims, France, 51092
        • Recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugene Marquis
        • Contact:
          • Julien Edeline, Site 0008
          • Phone Number: +33299253196
      • Suresnes, France, 92150
        • Recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
    • Cedex 9
      • Avignon, Cedex 9, France, 84918
        • Recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
  • Germany
      • Mainz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-University Mainz
        • Contact:
          • Peter Galle, Site 0057
          • Phone Number: 4906131177275
      • Munich, Germany, 81377
        • Recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • University Hospital Frankfurt
        • Contact:
          • Joerg Trojan, Site 0035
          • Phone Number: 49(0)69 6301 7860
    • North Rhine-Westphalia
      • Duesseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf
        • Contact:
          • Christoph Roderburg, Site 0051
          • Phone Number: 4921100492118108030
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Thomas Yau, Site 0004
          • Phone Number: 85222554249
      • Shatin, Hong Kong, 999077
        • Recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • Italy
      • Padova, Italy, 35128
        • Recruiting
        • Oncology Institute Veneto IOV-IRCCS
        • Contact:
          • Francesca Bergamo, Site 0003
          • Phone Number: 393494963042
      • Roma, Italy, 00168
        • Recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • MI
      • Milano, MI, Italy, 20122
        • Recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Withdrawn
        • Local Institution - 0020
  • Japan
      • Tokyo, Japan, 1040045
        • Recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Recruiting
        • Ehime Prefectural Central Hospital
        • Contact:
          • Fujimasa Tada, Site 0048
          • Phone Number: 81899471111
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
        • Contact:
          • Kazushi Numata, Site 0050
          • Phone Number: 81452615656
    • Osaka
      • Osakasayama, Osaka, Japan, 5898511
        • Recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Min-Hee Ryu, Site 0056
          • Phone Number: 82230105935
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • Recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Aukaszczyka, Ambulatorium Chemioterapii
        • Contact:
          • Bogdan Zurawski, Site 0028
          • Phone Number: +48501446778
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-034
        • Recruiting
        • M Sklodowska Curie Memorial National Cancer Institute
        • Contact:
          • Lucjan Wyrwicz, Site 0016
          • Phone Number: 48225709223
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-219
        • Recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
        • Contact:
          • Marcia Cruz-Correa, Site 0052
          • Phone Number: 787-362-9625
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
        • Contact:
          • Mirelis Acosta Rivera, Site 0019
          • Phone Number: 7877520003545
      • San Juan, Puerto Rico, 00927
        • Withdrawn
        • Local Institution - 0019_NA
  • Singapore
      • Singapore, Singapore, 329563
        • Recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
      • Singapore, Singapore, 217562
        • Recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre
        • Contact:
          • David Wai Meng Tai, Site 0029
          • Phone Number: 6564368197
      • Singapore, Singapore, 308442
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
          • Chong Ming Yeo, Site 0018
          • Phone Number: +63596734
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Jaime Feliu, Site 0053
          • Phone Number: +34917277516
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Bruno Sangro, Site 0038
          • Phone Number: 34630957722
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Roberto Pazo Cid, Site 0040
          • Phone Number: 639386220
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Sede Madrid
      • Madrid, Sede Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Bruno Sangro, Site 0067
          • Phone Number: 34630957722
  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Teng-Yu Lee, Site 0024
          • Phone Number: 8864235925253309
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital NTUH
        • Contact:
          • Ann-Lii Cheng, Site 0046
          • Phone Number: 8862231234567251
      • Taipei, Taiwan, 11217
        • Recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
    • Tai Zhong Shi
      • District Taichung City, Tai Zhong Shi, Taiwan, 404
        • Recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California - Los Angeles
        • Contact:
          • Richard Finn, Site 0039
          • Phone Number: 310-586-2091
      • Los Angeles, California, United States, 90089
        • Recruiting
        • USC Norris Comprehensive Cancer Center
        • Contact:
          • Anthony El-Khoueiry, Site 0042
          • Phone Number: 323-865-3967
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Hematology Oncology Associates
        • Contact:
          • Ari Baron, Site 0034
          • Phone Number: 415-923-3012
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
        • Contact:
          • Aiwu He, Site 0030
          • Phone Number: 202-444-8642
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center
        • Contact:
          • Mark Yarchoan, Site 0059
          • Phone Number: 301-758-5862
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Mary Linton Peters, Site 0065
          • Phone Number: 617-667-2100
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center
        • Contact:
          • Elizabeth Walsh, Site 0060
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein School of Medicine Montefiore
        • Contact:
          • Yvonne Saenger, Site 0062
          • Phone Number: 212-659-8303
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • James Harding, Site 0061
          • Phone Number: 646-888-4314
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin/ Froedtert Hospital
        • Contact:
          • Aditya Shreenivas, Site 0033
          • Phone Number: 14148056700414805460

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 (Estimated)

June 4, 2024

Study Completion (Estimated)

December 15, 2026

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 (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

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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