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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05337137
Collaborator
(none)
162
Enrollment
20
Locations
2
Arms
32
Anticipated Duration (Months)
8.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination With Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Actual Study Start Date :
May 5, 2022
Anticipated Primary Completion Date :
Jan 3, 2025
Anticipated Study Completion Date :
Jan 4, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab

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

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

    • Drug: Bevacizumab
    Specified dose on specified days
    Other Names:
  • Avastin

    		•
    Experimental: Arm B: Placebo + Nivolumab + Bevacizumab

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

    • Drug: Bevacizumab
    Specified dose on specified days
    Other Names:
  • Avastin

    • Other: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of dose-limiting toxicities (DLTs) [Up to 6 weeks]

    2. Progression-free survival (PFS) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants [Assessed up to 3 years]

    Secondary Outcome Measures

    1. PFS by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive [Assessed up to 3 years]

    2. Objective response rate (ORR) by BICR per RECIST v1.1 in all randomized participants [Assessed up to 3 years]

    3. ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive [Assessed up to 3 years]

    4. Overall Survival (OS) of all randomized participants [Assessed up to 3 years]

    5. OS of all randomized participants that are LAG-3 positive [Assessed up to 3 years]

    6. Number of participants with adverse events (AEs) [Up to 135 days after participant's last dose]

    Eligibility Criteria

    Criteria

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

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

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC Norris Comprehensive Cancer Center Los Angeles California United States 90089
    2 University Of California - Los Angeles Los Angeles California United States 90095
    3 Albert Einstein School of Medicine Montefiore Bronx New York United States 10461
    4 $Form.Name New York New York United States 10065
    5 Local Institution - 0045 Camperdown New South Wales Australia 2050
    6 Local Institution - 0026 Heidelberg Victoria Australia 3084
    7 Local Institution - 0017 Nedlands Western Australia Australia 6009
    8 Local Institution Bondy France 93140
    9 Local Institution - 0001 Nice France 06202
    10 Local Institution - 0055 Munich Germany 81377
    11 Local Institution - 0058 Kanazawa Ishikawa Japan 9208641
    12 Local Institution - 0050 Yokohama-shi Kanagawa Japan 232-0024
    13 Local Institution - 0016 Warszawa Mazowieckie Poland 02-034
    14 Pan American Center for Oncology Trials, LLC Rio Piedras Puerto Rico 00927
    15 Local Institution - 0019_NA San Juan Puerto Rico 00927
    16 Local Institution - 0018 Singapore Singapore 308442
    17 Local Institution - 0053 Madrid Spain 28046
    18 Local Institution - 0043 Taichung Taiwan 40447
    19 Local Institution Taichung Taiwan 40705
    20 Local Institution Taipei Taiwan 11217

    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:
    NCT05337137
    Other Study ID Numbers:
    • CA224-106
    • 2021-003606-53
    • U1111-1267-1579
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 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
    Hepatocellular Carcinoma
    HCC
    Liver Cancer
    Relatlimab
    Nivolumab
    Bevacizumab
    First line HCC
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Bevacizumab
    Nivolumab

    Study Results

    No Results Posted as of Aug 18, 2022