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

NCT05337137 | Completed Phase 1 FDA Drug

• 3 other identifiers: CA224-1062021-003606-53U1111-1267-1579
• Study Type: interventional
• Target: 83
• Locations: 15 countries
• Sites: 61

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).

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma; HCC; Liver Cancer; Relatlimab; Nivolumab; Bevacizumab; First line HCC

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLTs)

  Up to 6 weeks

• Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Assessed up to 3 years

Secondary Outcomes (6)

• Progression Free Survival (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

• PFS by BICR per RECIST v1.1 in all randomized participants

  Assessed up to 3 years

• ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive

  Assessed up to 3 years

• Overall Survival (OS) of all randomized participants

  Assessed up to 3 years

• OS of all randomized participants that are LAG-3 positive

  Assessed up to 3 years

Study Arms (2)

Arm A: Relatlimab + Nivolumab + Bevacizumab

EXPERIMENTAL

Drug: Relatlimab; Drug: Nivolumab; Drug: Bevacizumab

Arm B: Placebo + Nivolumab + Bevacizumab

EXPERIMENTAL

Drug: Nivolumab; Drug: Bevacizumab; Other: Placebo

Interventions

Relatlimab DRUG

Specified dose on specified days

Also known as: BMS-986016

Arm A: Relatlimab + Nivolumab + Bevacizumab

Nivolumab DRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Arm A: Relatlimab + Nivolumab + Bevacizumab; Arm B: Placebo + Nivolumab + Bevacizumab

Bevacizumab DRUG

Specified dose on specified days

Also known as: Avastin

Arm A: Relatlimab + Nivolumab + Bevacizumab; Arm B: Placebo + Nivolumab + Bevacizumab

Placebo OTHER

Specified dose on specified days

Arm B: Placebo + Nivolumab + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (61)

Local Institution - 0042

Los Angeles, California, 90033, United States

Location

Local Institution - 0039

Los Angeles, California, 90095, United States

Location

Local Institution - 0034

San Francisco, California, 94115, United States

Location

Local Institution - 0030

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0059

Baltimore, Maryland, 21231, United States

Location

Local Institution - 0060

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0065

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0061

New York, New York, 10065, United States

Location

Local Institution - 0062

The Bronx, New York, 10461, United States

Location

Local Institution - 0033

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0045

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0022

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0026

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0013

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0017

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0025

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0009

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0064

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0066

Xi'an, Shan3xi, 710700, China

Location

Local Institution - 0021

Avignon, Cedex 9, 84918, France

Location

Local Institution - 0012

Grenoble, 38043, France

Location

Local Institution - 0001

Nice, 06202, France

Location

Local Institution - 0002

Reims, 51092, France

Location

Local Institution - 0008

Rennes, 35042, France

Location

Local Institution - 0054

Suresnes, 92151, France

Location

Local Institution - 0051

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Local Institution - 0035

Frankfurt, 60590, Germany

Location

Local Institution - 0057

Mainz, 55131, Germany

Location

Local Institution - 0055

Munich, 81377, Germany

Location

Local Institution - 0004

Hong Kong, 0, Hong Kong

Location

Local Institution - 0031

Shatin, 999077, Hong Kong

Location

Local Institution - 0036

Milan, 20122, Italy

Location

Local Institution - 0003

Padua, 35128, Italy

Location

Local Institution - 0010

Roma, 00168, Italy

Location

Local Institution - 0047

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0048

Matsuyama, Ehime, 7900024, Japan

Location

Local Institution - 0058

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution - 0050

Yokohama, Kanagawa, 2320024, Japan

Location

Local Institution - 0041

Sayama, Osaka, 5898511, Japan

Location

Local Institution - 0063

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 0028

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Local Institution - 0016

Warsaw, Masovian Voivodeship, 02-034, Poland

Location

Local Institution - 0023

Gdansk, 80-219, Poland

Location

Local Institution - 0052

Rio Piedras, PR, 935, Puerto Rico

Location

Local Institution - 0019

San Juan, 00927, Puerto Rico

Location

Local Institution - 0029

Singapore, 168583, Singapore

Location

Local Institution - 0027

Singapore, 217562, Singapore

Location

Local Institution - 0018

Singapore, 308433, Singapore

Location

Local Institution - 0044

Singapore, 329563, Singapore

Location

Local Institution - 0037

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Local Institution - 0056

Seoul, 138-736, South Korea

Location

Local Institution - 0032

Santiago de Compostela, A Coruña, 15706, Spain

Location

Local Institution - 0007

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0067

Madrid, Sede Madrid, 28027, Spain

Location

Local Institution - 0053

Madrid, 28046, Spain

Location

Local Institution - 0038

Pamplona, 31008, Spain

Location

Local Institution - 0040

Zaragoza, 50009, Spain

Location

Local Institution - 0043

District Taichung City, Tai Zhong Shi, 404, Taiwan

Location

Local Institution - 0024

Taichung, 40705, Taiwan

Location

Local Institution - 0046

Taipei, 10048, Taiwan

Location

Local Institution - 0049

Taipei, 11217, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

relatlimab; Nivolumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: May 5, 2022
• Primary Completion: July 5, 2025
• Study Completion: November 18, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

PL (3); PR (2); FR (6); AU (5); JP (6); US (10); CN (2); DE (4); HK (2); ES (6); IT (3); TW (4); CA (2); SG (4); KR (2)