A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

NCT ID: NCT05337137

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2025-11-18

Brief Summary

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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).

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm A: Relatlimab + Nivolumab + Bevacizumab

Group Type EXPERIMENTAL

Relatlimab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Arm B: Placebo + Nivolumab + Bevacizumab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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Relatlimab

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Bevacizumab

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-986016 BMS-936558 Opdivo Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0042

Los Angeles, California, United States

Site Status

Local Institution - 0039

Los Angeles, California, United States

Site Status

Local Institution - 0034

San Francisco, California, United States

Site Status

Local Institution - 0030

Washington D.C., District of Columbia, United States

Site Status

Local Institution - 0059

Baltimore, Maryland, United States

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Local Institution - 0060

Boston, Massachusetts, United States

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Local Institution - 0065

Boston, Massachusetts, United States

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Local Institution - 0061

New York, New York, United States

Site Status

Local Institution - 0062

The Bronx, New York, United States

Site Status

Local Institution - 0033

Milwaukee, Wisconsin, United States

Site Status

Local Institution - 0045

Camperdown, New South Wales, Australia

Site Status

Local Institution - 0022

Adelaide, South Australia, Australia

Site Status

Local Institution - 0026

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0013

Melbourne, Victoria, Australia

Site Status

Local Institution - 0017

Nedlands, Western Australia, Australia

Site Status

Local Institution - 0025

Edmonton, Alberta, Canada

Site Status

Local Institution - 0009

Toronto, Ontario, Canada

Site Status

Local Institution - 0064

Guangzhou, Guangdong, China

Site Status

Local Institution - 0066

Xi'an, Shan3xi, China

Site Status

Local Institution - 0021

Avignon, Cedex 9, France

Site Status

Local Institution - 0012

Grenoble, , France

Site Status

Local Institution - 0001

Nice, , France

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Local Institution - 0002

Reims, , France

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Local Institution - 0008

Rennes, , France

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Local Institution - 0054

Suresnes, , France

Site Status

Local Institution - 0051

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Local Institution - 0035

Frankfurt, , Germany

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Local Institution - 0057

Mainz, , Germany

Site Status

Local Institution - 0055

Munich, , Germany

Site Status

Local Institution - 0004

Hong Kong, , Hong Kong

Site Status

Local Institution - 0031

Shatin, , Hong Kong

Site Status

Local Institution - 0036

Milan, , Italy

Site Status

Local Institution - 0003

Padua, , Italy

Site Status

Local Institution - 0010

Roma, , Italy

Site Status

Local Institution - 0047

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution - 0048

Matsuyama, Ehime, Japan

Site Status

Local Institution - 0058

Kanazawa, Ishikawa-ken, Japan

Site Status

Local Institution - 0050

Yokohama, Kanagawa, Japan

Site Status

Local Institution - 0041

Sayama, Osaka, Japan

Site Status

Local Institution - 0063

Chuo-ku, Tokyo, Japan

Site Status

Local Institution - 0028

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Local Institution - 0016

Warsaw, Masovian Voivodeship, Poland

Site Status

Local Institution - 0023

Gdansk, , Poland

Site Status

Local Institution - 0052

Rio Piedras, PR, Puerto Rico

Site Status

Local Institution - 0019

San Juan, , Puerto Rico

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Local Institution - 0029

Singapore, , Singapore

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Local Institution - 0027

Singapore, , Singapore

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Local Institution - 0018

Singapore, , Singapore

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Local Institution - 0044

Singapore, , Singapore

Site Status

Local Institution - 0037

Seongnam-si, Gyeonggido, South Korea

Site Status

Local Institution - 0056

Seoul, , South Korea

Site Status

Local Institution - 0032

Santiago de Compostela, A Coruña, Spain

Site Status

Local Institution - 0007

Santander, Cantabria, Spain

Site Status

Local Institution - 0067

Madrid, Sede Madrid, Spain

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Local Institution - 0053

Madrid, , Spain

Site Status

Local Institution - 0038

Pamplona, , Spain

Site Status

Local Institution - 0040

Zaragoza, , Spain

Site Status

Local Institution - 0043

District Taichung City, Tai Zhong Shi, Taiwan

Site Status

Local Institution - 0024

Taichung, , Taiwan

Site Status

Local Institution - 0046

Taipei, , Taiwan

Site Status

Local Institution - 0049

Taipei, , Taiwan

Site Status

Countries

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United States Australia Canada China France Germany Hong Kong Italy Japan Poland Puerto Rico Singapore South Korea Spain Taiwan

Related Links

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Other Identifiers

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2021-003606-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1267-1579

Identifier Type: OTHER

Identifier Source: secondary_id

CA224-106

Identifier Type: -

Identifier Source: org_study_id

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