A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

NCT04567615 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CA224-0732018-003151-38U1111-1218-6499
• Study Type: interventional
• Target: 266
• Locations: 17 countries
• Sites: 65

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Conditions

Liver Cancer, Adult; Liver Cell Carcinoma; Liver Cell Carcinoma, Adult; Hepatocellular Carcinoma; Hepatoma

Keywords

Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Liver Cancer; Liver Cancer, Adult; Liver Cell Carcinoma; Liver Cell Carcinoma, Adult

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR) Assessed by BICR

  Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.

  From randomization to primary completion date (Approximately 29.5 Months)

Secondary Outcomes (14)

• Disease Control Rate Assessed by BICR

  From randomization to primary completion date (Approximately 29.5 Months)

• Duration of Response Assessed by BICR

  From randomization to primary completion date (Approximately 29.5 Months)

• Progression Free Survival(PFS) Assessed by BICR

  From randomization to primary completion date (Approximately 29.5 Months)

• Objective Response Rate Assessed by Investigator

  From randomization to primary completion date (Approximately 29.5 Months)

• Disease Control Rate Assessed by Investigator

  From randomization to primary completion date (Approximately 29.5 Months)

Study Arms (3)

Arm A : Nivolumab

EXPERIMENTAL

Biological: Nivolumab

Arm B : Nivolumab + Relatlimab Dose 1

EXPERIMENTAL

Biological: Nivolumab; Biological: Relatlimab

Arm C : Nivolumab + Relatlimab Dose 2

EXPERIMENTAL

Biological: Nivolumab; Biological: Relatlimab

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: OPDIVO, BMS-936558

Arm A : Nivolumab; Arm B : Nivolumab + Relatlimab Dose 1; Arm C : Nivolumab + Relatlimab Dose 2

Relatlimab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986016

Arm B : Nivolumab + Relatlimab Dose 1; Arm C : Nivolumab + Relatlimab Dose 2

Eligibility Criteria

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

You may qualify if:

• Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
• Must have advanced/metastatic HCC
• Have to be immunotherapy treatment-naive in the advanced/metastatic setting
• Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
• Child-Pugh score of 5 or 6
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
• Prior organ allograft or allogeneic bone marrow transplantation
• No uncontrolled or significant cardiovascular disease
• No active known autoimmune disease
• Have received one or two lines of tyrosine kinase inhibitor therapies
• Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (65)

Local Institution - 0010

Ciudad de Buenos Aires, Buenos Aires, 1181, Argentina

Location

Local Institution - 0019

Buenos Aires, Distrito Federal, C1096AAS, Argentina

Location

Local Institution - 0017

Rosario, Santa Fe Province, S2002KDS, Argentina

Location

Local Institution - 0063

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0025

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0060

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0016

Barretos, São Paulo, 14784400, Brazil

Location

Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Local Institution - 0015

São Paulo, São Paulo, 01246-000, Brazil

Location

Local Institution - 0024

Temuco, Región de la Araucanía, 4800827, Chile

Location

Local Institution - 0029

Santiago, Santiago Metropolitan, 000000, Chile

Location

Local Institution - 0018

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0113

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0114

Changsha, Hunan, 410013, China

Location

Local Institution - 0118

Xi'an, Shaanxi, 710061, China

Location

Local Institution - 0108

Xi'an, Shan3xi, 710126, China

Location

Local Institution - 0107

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0117

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0048

Brno, 65653, Czechia

Location

Local Institution - 0047

Hradec Králové, 50005, Czechia

Location

Local Institution - 0046

Prague, 140 59, Czechia

Location

Local Institution - 0069

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Local Institution - 0068

Clichy, 92110, France

Location

Local Institution - 0105

Grenoble, 38043, France

Location

Local Institution - 0074

Lyon, 69004, France

Location

Local Institution - 0067

Pessac, 33600, France

Location

Local Institution - 0077

Hksar, 0, Hong Kong

Location

Local Institution - 0079

Shatin, 0, Hong Kong

Location

Local Institution - 0072

Matsuyama, Ehime, 790-0024, Japan

Location

Local Institution - 0054

Yokohama, Kanagawa, 232-0024, Japan

Location

Local Institution - 0076

Yokohama, Kanagawa, 241-8515, Japan

Location

Local Institution - 0045

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0075

Ishikawa, 920-8641, Japan

Location

Local Institution - 0071

Kyoto, 602-8566, Japan

Location

Local Institution - 0101

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

Local Institution - 0100

Cuauhtémoc, 06700, Mexico

Location

Local Institution - 0106

Oaxaca City, 68020, Mexico

Location

Local Institution - 0003

Auckland, 1023, New Zealand

Location

Local Institution - 0013

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Local Institution - 0012

Bytom, 41-900, Poland

Location

Local Institution - 0009

Mysowice, 41-400, Poland

Location

Local Institution - 0039

Warsaw, 02-034, Poland

Location

Local Institution - 0038

Craiova, Dolj, 200542, Romania

Location

Local Institution - 0037

Bucharest, 022328, Romania

Location

Local Institution - 0036

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0070

Suceava, 720214, Romania

Location

Local Institution - 0001

Singapore, Central Singapore, 168583, Singapore

Location

Local Institution - 0004

Singapore, 308433, Singapore

Location

Local Institution - 0011

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Local Institution - 0020

Seongnam-si, 13496, South Korea

Location

Local Institution - 0043

Seoul, 06351, South Korea

Location

Local Institution - 0050

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Local Institution - 0066

Barcelona, 08036, Spain

Location

Local Institution - 0073

Córdoba, 14004, Spain

Location

Local Institution - 0051

Madrid, 28009, Spain

Location

Local Institution - 0049

Madrid, 28041, Spain

Location

Local Institution - 0058

Pamplona, 31008, Spain

Location

Local Institution - 0041

Taichung, 40447, Taiwan

Location

Local Institution - 0034

Tainan, 704, Taiwan

Location

Local Institution - 0031

Taipei, 100, Taiwan

Location

Local Institution - 0042

Taipei, 11217, Taiwan

Location

Local Institution - 0032

Taoyuan District, 333, Taiwan

Location

Local Institution - 0089

Ankara, 06230, Turkey (Türkiye)

Location

Local Institution - 0090

Edirne, 22030, Turkey (Türkiye)

Location

Local Institution - 0091

Kadiköy/Istanbul, 41380, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Nivolumab; relatlimab

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: February 4, 2021
• Primary Completion: August 31, 2023
• Study Completion: November 19, 2025
• Last Updated: January 8, 2026
• Results First Posted: October 8, 2024

Record last verified: 2025-12

Locations

SG (2); NZ (1); TU (3); TW (5); RO (4); BR (5); ES (6); HK (2); CL (3); ME (3); AR (4); JP (6); PL (4); CZ (3); KR (3); FR (5); CN (6)