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Hepatocellular CarcinomaPhase 2NCT04567615

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

A Phase 2 study testing Nivolumab and Relatlimab in people with Hepatocellular Carcinoma and Hepatoma, run by Bristol-Myers Squibb at 65 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Relatlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
65 sitesin 17 countries
Study dates
4 Feb 2021to 19 Nov 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

65 sites in 17 countries.

65 sites in 17 countries

China6 sites
  • Local Institution - 0114

    Changsha, Hunan, 410013

  • Local Institution - 0117

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0113

    Harbin, Heilongjiang, 150081

  • Local Institution - 0107

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0118

    Xi'an, Shaanxi, 710061

  • Local Institution - 0108

    Xi'an, Shan3xi, 710126

Other trials in China

Japan6 sites
  • Local Institution - 0075

    Ishikawa, 920-8641

  • Local Institution - 0071

    Kyoto, 602-8566

  • Local Institution - 0072

    Matsuyama, Ehime, 790-0024

  • Local Institution - 0045

    Ōsaka-sayama, Osaka, 589-8511

  • Local Institution - 0054

    Yokohama, Kanagawa, 232-0024

  • Local Institution - 0076

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Spain6 sites
  • Local Institution - 0066

    Barcelona, 08036

  • Local Institution - 0073

    Córdoba, 14004

  • Local Institution - 0050

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Local Institution - 0051

    Madrid, 28009

  • Local Institution - 0049

    Madrid, 28041

  • Local Institution - 0058

    Pamplona, 31008

Other trials in Spain

Brazil5 sites
  • Local Institution - 0016

    Barretos, São Paulo, 14784400

  • Local Institution - 0025

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0060

    Porto Alegre, Rio Grande do Sul, 91350-200

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

    Ribeirão Preto, São Paulo, 14051-140

  • Local Institution - 0015

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

France5 sites
  • Local Institution - 0068

    Clichy, 92110

  • Local Institution - 0105

    Grenoble, 38043

  • Local Institution - 0074

    Lyon, 69004

  • Local Institution - 0067

    Pessac, 33600

  • Local Institution - 0069

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

Other trials in France

Taiwan5 sites
  • Local Institution - 0041

    Taichung, 40447

  • Local Institution - 0034

    Tainan, 704

  • Local Institution - 0031

    Taipei, 100

  • Local Institution - 0042

    Taipei, 11217

  • Local Institution - 0032

    Taoyuan, 333

Other trials in Taiwan

Argentina4 sites
  • Local Institution - 0019

    Buenos Aires, Distrito Federal, C1096AAS

  • Local Institution - 0010

    Ciudad de Buenos Aires, Buenos Aires, 1181

  • Local Institution - 0017

    Rosario, Santa Fe Province, S2002KDS

  • Local Institution - 0063

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Poland4 sites
  • Local Institution - 0012

    Bytom, 41-900

  • Local Institution - 0013

    Krakow, Lesser Poland Voivodeship, 31-501

  • Local Institution - 0009

    Mysowice, 41-400

  • Local Institution - 0039

    Warsaw, 02-034

Other trials in Poland

Romania4 sites
  • Local Institution - 0037

    Bucharest, 022328

  • Local Institution - 0036

    Cluj-Napoca, 400015

  • Local Institution - 0038

    Craiova, Dolj, 200542

  • Local Institution - 0070

    Suceava, 720214

Other trials in Romania

Chile3 sites
  • Local Institution - 0029

    Santiago, Santiago Metropolitan, 000000

  • Local Institution - 0018

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0024

    Temuco, Araucania, 4800827

Other trials in Chile

Czechia3 sites
  • Local Institution - 0048

    Brno, 65653

  • Local Institution - 0047

    Hradec Králové, 50005

  • Local Institution - 0046

    Prague, 140 59

Other trials in Czechia

Mexico3 sites
  • Local Institution - 0100

    Cuauhtémoc, 06700

  • Local Institution - 0106

    Oaxaca City, 68020

  • Local Institution - 0101

    San Luis Potosí City, San Luis Potosí, 78250

Other trials in Mexico

South Korea3 sites
  • Local Institution - 0020

    Seongnam-si, 13496

  • Local Institution - 0011

    Seoul, Seoul-teukbyeolsi, 05505

  • Local Institution - 0043

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)3 sites
  • Local Institution - 0089

    Ankara, 06230

  • Local Institution - 0090

    Edirne, 22030

  • Local Institution - 0091

    Kadiköy/Istanbul, 41380

Other trials in Turkey (Türkiye)

Hong Kong2 sites
  • Local Institution - 0077

    Hksar, 0

  • Local Institution - 0079

    Shatin, 0

Other trials in Hong Kong

Singapore2 sites
  • Local Institution - 0001

    Singapore, Central Singapore, 168583

  • Local Institution - 0004

    Singapore, 308433

Other trials in Singapore

New Zealand1 site
  • Local Institution - 0003

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

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.

Being tested
Nivolumab, Relatlimab
Keywords
Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called OPDIVO, BMS-936558

    Specified dose on specified days

  • RelatlimabBiological

    Also called BMS-986016

    Specified dose on specified days

Study groups in NCT04567615
Study groupRoleWhat they receive
Arm A : NivolumabExperimentalNot described
Receives: Biological: Nivolumab
Arm B : Nivolumab + Relatlimab Dose 1ExperimentalNot described
Receives: Biological: Nivolumab; Biological: Relatlimab
Arm C : Nivolumab + Relatlimab Dose 2ExperimentalNot described
Receives: Biological: Nivolumab; Biological: Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

Secondary outcomes (14)
  1. Disease Control Rate Assessed by BICR

    Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  2. Duration of Response Assessed by BICR

    Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first.

    Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  3. Progression Free Survival(PFS) Assessed by BICR

    PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first.

    Participants who die without a reported progression will be considered to have progressed on the date of their death.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  4. Objective Response Rate Assessed by Investigator

    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 investigator assessments among all participants in the respective analysis set.

    BOR is defined as the best response, as determined by the investigator, 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.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  5. Disease Control Rate Assessed by Investigator

    Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  6. Duration of Response Assessed by Investigator

    Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first.

    Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  7. Progression Free Survival(PFS) Assessed by Investigator

    PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first.

    Participants who die without a reported progression will be considered to have progressed on the date of their death.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  8. Overall Survival (OS)

    Overall survival (OS) is defined as the time from randomization to the date of death from any cause.

    Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  9. Number of Participants With Adverse Events

    Number of participants with an Adverse Event.

    An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

    Measured: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

  10. Number of Participants With Serious Adverse Events

    Number of participants with Serious Adverse Events

    A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

    Measured: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

  11. Number of Participants With Adverse Events Leading to Discontinuation

    Number of participants with Adverse Events Leading to Discontinuation

    Measured: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

  12. Death Summary

    Number of participants who died.

    Measured: From randomization to primary completion date (Approximately 29.5 Months)

  13. Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

    Number of participants with clinical laboratory abnormalities in specific liver tests

    Measured: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

  14. Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests

    Number of participants with clinical laboratory abnormalities in thyroid tests

    Measured: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start4 Feb 2021
  3. Primary completion31 Aug 2023
  4. Study completion19 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04567615
Sponsor's protocol ID
CA224-073
Other IDs
2018-003151-38, U1111-1218-6499, 2018
Status last verified
Dec 2025
First submitted
24 Sep 2020
Last updated
8 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Relatlimab in people with Hepatocellular Carcinoma and Hepatoma, run by Bristol-Myers Squibb at 65 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in China, Japan, Spain, Brazil, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) Assessed by BICR (time frame: From randomization to primary completion date (Approximately 29.5 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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