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Immunotherapy combo shows promise in advanced liver cancer

NCT ID NCT01658878

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two immunotherapy drugs, nivolumab and ipilimumab, in people with advanced liver cancer that could not be treated with surgery. The goal was to see if these drugs could shrink tumors and control the disease. The trial included 657 adults and found that the treatments could help some patients, but they are not a cure and may require ongoing management.

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

657 people

The number who actually took part.

Started

Oct 2012

Finished

Nov 2024

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.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less Exclusion Criteria: * History of autoimmune disease * Any prior or current clinically significant ascites * Any history of hepatic encephalopathy

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

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

Hepatocellular carcinoma

Contacts and locations

Locations

  • Local Institution - 0001

    Portland, Oregon, 97213, United States

  • Local Institution - 0002

    Ann Arbor, Michigan, 48109-5331, United States

  • Local Institution - 0003

    Pamplona, 31008, Spain

  • Local Institution - 0005

    Hong Kong, 0, Hong Kong

  • Local Institution - 0006

    Hong Kong, Hong Kong

  • Local Institution - 0007

    Singapore, 308433, Singapore

  • Local Institution - 0008

    Los Angeles, California, 90033, United States

  • Local Institution - 0009

    Singapore, 168583, Singapore

  • Local Institution - 0010

    London, NW3 2QG, United Kingdom

  • Local Institution - 0011

    London, Greater London, SE19RT, United Kingdom

  • Local Institution - 0012

    Glasgow, Lanarkshire, G12 0YN, United Kingdom

  • Local Institution - 0013

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Local Institution - 0014

    Manchester, Greater Manchester, M20 4BX, United Kingdom

  • Local Institution - 0015

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

  • Local Institution - 0016

    Seoul, 06351, South Korea

  • Local Institution - 0017

    Singapore, 119074, Singapore

  • Local Institution - 0018

    Madrid, 28050, Spain

  • Local Institution - 0019

    Barcelona, 08036, Spain

  • Local Institution - 0020

    Madrid, 28009, Spain

  • Local Institution - 0021

    Seoul, 03080, South Korea

  • Local Institution - 0022

    Montreal, Quebec, H2X 3E4, Canada

  • Local Institution - 0023

    Taoyuan, 333, Taiwan

  • Local Institution - 0024

    Taipei, 112, Taiwan

  • Local Institution - 0025

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0026

    Seoul, 05505, South Korea

  • Local Institution - 0027

    Taipei, 100, Taiwan

  • Local Institution - 0028

    Frankfurt, 60590, Germany

  • Local Institution - 0029

    Hanover, 30625, Germany

  • Local Institution - 0030

    Essen, 45147, Germany

  • Local Institution - 0031

    Heidelberg, 69120, Germany

  • Local Institution - 0032

    Bologna, 40138, Italy

  • Local Institution - 0034

    Naples, 80131, Italy

  • Local Institution - 0035

    Padova, Padova, Italy

  • Local Institution - 0036

    Kashiwa-shi, Chiba, 2778577, Japan

  • Local Institution - 0037

    Ōsaka-sayama, Osaka, 5898511, Japan

  • Local Institution - 0038

    Kurume-shi, Fukuoka, 8300011, Japan

  • Local Institution - 0039

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0040

    Rozzano, 20089, Italy

  • Local Institution - 0042

    Paris, 75651, France

  • Local Institution - 0047

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0048

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

  • Local Institution - 0049

    Yokohama, Kanagawa, 2320024, Japan

  • Local Institution - 0050

    Kyoto, Kyoto, 6028566, Japan

  • Local Institution - 0051

    Saga, 8408571, Japan

  • Local Institution - 0053

    Pensacola, Florida, 32504, United States

  • Local Institution - 0054

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 0055

    Milan, 20141, Italy

  • Local Institution - 0056

    Florence, 50134, Italy

  • Local Institution - 0058

    Vandœuvre-lès-Nancy, 54500, France

  • Local Institution - 0059

    Marseille, 13385, France

  • Local Institution - 0060

    Reims, 51092, France

  • Local Institution - 0061

    Angers, 49933, France

  • Local Institution - 0062

    Marseille, 13273, France

  • Local Institution - 0063

    Meldola (FC), 47014, Italy

  • Local Institution - 0064

    Créteil, 94010, France

  • Local Institution - 0065

    Halifax, Nova Scotia, B4H 2Y9, Canada

  • Local Institution - 0066

    Seoul, 02841, South Korea

  • Local Institution - 0067

    Paterson, New Jersey, 07503, United States

  • Local Institution - 0070

    San Juan, 00927, Puerto Rico

  • The University Of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.