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Triple drug cocktail shows promise for untreated liver cancer

NCT ID NCT05337137

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding a third drug (relatlimab) to a two-drug combination (nivolumab and bevacizumab) is safe and works better for people with advanced liver cancer who haven't had treatment before. The 83 participants received either the three-drug combo or the two-drug combo plus a placebo. Researchers looked at side effects and how many patients' tumors shrank.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab, relatlimab, and bevacizumab (three drugs given together)
What this could lead to
If this works, it could offer a new, more effective treatment option for people with advanced liver cancer who haven't had prior therapy.
What could go wrong
This is an early-phase trial with only 83 participants, so results may not apply to everyone. Combining three drugs also raises the risk of more severe side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

83 people

The number who actually took part.

Started

May 2022

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.

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 Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma Liver Neoplasms

As listed by the trial registrant

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

Carcinoma, hepatocellular

Contacts and locations

Locations

  • Local Institution - 0001

    Nice, 06202, France

  • Local Institution - 0002

    Reims, 51092, France

  • Local Institution - 0003

    Padova, 35128, Italy

  • Local Institution - 0004

    Hong Kong, 0, Hong Kong

  • Local Institution - 0007

    Santander, Cantabria, 39008, Spain

  • Local Institution - 0008

    Rennes, 35042, France

  • Local Institution - 0009

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0010

    Roma, 00168, Italy

  • Local Institution - 0012

    Grenoble, 38043, France

  • Local Institution - 0013

    Melbourne, Victoria, 3065, Australia

  • Local Institution - 0016

    Warsaw, Masovian Voivodeship, 02-034, Poland

  • Local Institution - 0017

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0018

    Singapore, 308433, Singapore

  • Local Institution - 0019

    San Juan, 00927, Puerto Rico

  • Local Institution - 0021

    Avignon, Cedex 9, 84918, France

  • Local Institution - 0022

    Adelaide, South Australia, 5000, Australia

  • Local Institution - 0023

    Gdansk, 80-219, Poland

  • Local Institution - 0024

    Taichung, 40705, Taiwan

  • Local Institution - 0025

    Edmonton, Alberta, T6G 1Z2, Canada

  • Local Institution - 0026

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0027

    Singapore, 217562, Singapore

  • Local Institution - 0028

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

  • Local Institution - 0029

    Singapore, 168583, Singapore

  • Local Institution - 0030

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

  • Local Institution - 0031

    Shatin, 999077, Hong Kong

  • Local Institution - 0032

    Santiago de Compostela, A Coruña, 15706, Spain

  • Local Institution - 0033

    Milwaukee, Wisconsin, 53226, United States

  • Local Institution - 0034

    San Francisco, California, 94115, United States

  • Local Institution - 0035

    Frankfurt, 60590, Germany

  • Local Institution - 0036

    Milan, 20122, Italy

  • Local Institution - 0037

    Seongnam-si, Gyeonggido, 13496, South Korea

  • Local Institution - 0038

    Pamplona, 31008, Spain

  • Local Institution - 0039

    Los Angeles, California, 90095, United States

  • Local Institution - 0040

    Zaragoza, 50009, Spain

  • Local Institution - 0041

    Sayama, Osaka, 5898511, Japan

  • Local Institution - 0042

    Los Angeles, California, 90033, United States

  • Local Institution - 0043

    District Taichung City, Tai Zhong Shi, 404, Taiwan

  • Local Institution - 0044

    Singapore, 329563, Singapore

  • Local Institution - 0045

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0046

    Taipei, 10048, Taiwan

  • Local Institution - 0047

    Kashiwa-shi, Chiba, 2778577, Japan

  • Local Institution - 0048

    Matsuyama, Ehime, 7900024, Japan

  • Local Institution - 0049

    Taipei, 11217, Taiwan

  • Local Institution - 0050

    Yokohama, Kanagawa, 2320024, Japan

  • Local Institution - 0051

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Local Institution - 0052

    Rio Piedras, PR, 935, Puerto Rico

  • Local Institution - 0053

    Madrid, 28046, Spain

  • Local Institution - 0054

    Suresnes, 92151, France

  • Local Institution - 0055

    Munich, 81377, Germany

  • Local Institution - 0056

    Seoul, 138-736, South Korea

  • Local Institution - 0057

    Mainz, 55131, Germany

  • Local Institution - 0058

    Kanazawa, Ishikawa-ken, 9208641, Japan

  • Local Institution - 0059

    Baltimore, Maryland, 21231, United States

  • Local Institution - 0060

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0061

    New York, New York, 10065, United States

  • Local Institution - 0062

    The Bronx, New York, 10461, United States

  • Local Institution - 0063

    Chuo-ku, Tokyo, 104-0045, Japan

  • Local Institution - 0064

    Guangzhou, Guangdong, 510515, China

  • Local Institution - 0065

    Boston, Massachusetts, 02215, United States

  • Local Institution - 0066

    Xi'an, Shan3xi, 710700, China

  • Local Institution - 0067

    Madrid, Sede Madrid, 28027, Spain

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