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New combo therapy shows promise for Tough-to-Treat liver cancer

NCT ID NCT04567615

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, relatlimab and nivolumab, in 266 adults with advanced liver cancer who had not received immunotherapy before but whose cancer worsened after other treatments. The goal was to see if the combination could shrink tumors or control the disease. While not a cure, the approach aims to give patients more time and better control over their cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

266 people

The number who actually took part.

Started

Feb 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

adult hepatocellular carcinoma hepatocellular carcinoma liver cancer Liver Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma Hepatoma Liver cancer, adult Liver cell carcinoma Liver cell carcinoma, adult

Contacts and locations

Locations

  • Local Institution - 0001

    Singapore, Central Singapore, 168583, Singapore

  • Local Institution - 0003

    Auckland, 1023, New Zealand

  • Local Institution - 0004

    Singapore, 308433, Singapore

  • Local Institution - 0009

    Mysowice, 41-400, Poland

  • Local Institution - 0010

    Ciudad de Buenos Aires, Buenos Aires, 1181, Argentina

  • Local Institution - 0011

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Local Institution - 0012

    Bytom, 41-900, Poland

  • Local Institution - 0013

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Local Institution - 0015

    São Paulo, São Paulo, 01246-000, Brazil

  • Local Institution - 0016

    Barretos, São Paulo, 14784400, Brazil

  • Local Institution - 0017

    Rosario, Santa Fe Province, S2002KDS, Argentina

  • Local Institution - 0018

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0019

    Buenos Aires, Distrito Federal, C1096AAS, Argentina

  • Local Institution - 0020

    Seongnam-si, 13496, South Korea

  • Local Institution - 0024

    Temuco, Araucania, 4800827, Chile

  • Local Institution - 0025

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Local Institution - 0029

    Santiago, Santiago Metropolitan, 000000, Chile

  • Local Institution - 0031

    Taipei, 100, Taiwan

  • Local Institution - 0032

    Taoyuan, 333, Taiwan

  • Local Institution - 0034

    Tainan, 704, Taiwan

  • Local Institution - 0036

    Cluj-Napoca, 400015, Romania

  • Local Institution - 0037

    Bucharest, 022328, Romania

  • Local Institution - 0038

    Craiova, Dolj, 200542, Romania

  • Local Institution - 0039

    Warsaw, 02-034, Poland

  • Local Institution - 0041

    Taichung, 40447, Taiwan

  • Local Institution - 0042

    Taipei, 11217, Taiwan

  • Local Institution - 0043

    Seoul, 06351, South Korea

  • Local Institution - 0045

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Local Institution - 0046

    Prague, 140 59, Czechia

  • Local Institution - 0047

    Hradec Králové, 50005, Czechia

  • Local Institution - 0048

    Brno, 65653, Czechia

  • Local Institution - 0049

    Madrid, 28041, Spain

  • Local Institution - 0050

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Local Institution - 0051

    Madrid, 28009, Spain

  • Local Institution - 0054

    Yokohama, Kanagawa, 232-0024, Japan

  • Local Institution - 0058

    Pamplona, 31008, Spain

  • Local Institution - 0060

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

  • Local Institution - 0063

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Local Institution - 0066

    Barcelona, 08036, Spain

  • Local Institution - 0067

    Pessac, 33600, France

  • Local Institution - 0068

    Clichy, 92110, France

  • Local Institution - 0069

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

  • Local Institution - 0070

    Suceava, 720214, Romania

  • Local Institution - 0071

    Kyoto, 602-8566, Japan

  • Local Institution - 0072

    Matsuyama, Ehime, 790-0024, Japan

  • Local Institution - 0073

    Córdoba, 14004, Spain

  • Local Institution - 0074

    Lyon, 69004, France

  • Local Institution - 0075

    Ishikawa, 920-8641, Japan

  • Local Institution - 0076

    Yokohama, Kanagawa, 241-8515, Japan

  • Local Institution - 0077

    Hksar, 0, Hong Kong

  • Local Institution - 0079

    Shatin, 0, Hong Kong

  • Local Institution - 0089

    Ankara, 06230, Turkey (Türkiye)

  • Local Institution - 0090

    Edirne, 22030, Turkey (Türkiye)

  • Local Institution - 0091

    Kadiköy/Istanbul, 41380, Turkey (Türkiye)

  • Local Institution - 0100

    Cuauhtémoc, 06700, Mexico

  • Local Institution - 0101

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

  • Local Institution - 0105

    Grenoble, 38043, France

  • Local Institution - 0106

    Oaxaca City, 68020, Mexico

  • Local Institution - 0107

    Shanghai, Shanghai Municipality, 200032, China

  • Local Institution - 0108

    Xi'an, Shan3xi, 710126, China

  • Local Institution - 0113

    Harbin, Heilongjiang, 150081, China

  • Local Institution - 0114

    Changsha, Hunan, 410013, China

  • Local Institution - 0117

    Hangzhou, Zhejiang, 310016, China

  • Local Institution - 0118

    Xi'an, Shaanxi, 710061, China

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

    Ribeirão Preto, São Paulo, 14051-140, Brazil

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