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Immunotherapy combo shows promise in early liver cancer trial

NCT ID NCT04658147

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether giving the immunotherapy drugs nivolumab (Opdivo) with or without relatlimab before and after surgery is safe and feasible for people with liver cancer that can be removed. About 31 participants will receive the drugs before surgery, then continue for up to a year after. The goal is to see if this approach helps control the cancer and allows more patients to proceed with surgery.

What this could mean

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

Active substance
nivolumab (Opdivo) with or without relatlimab
What this could lead to
If successful, this could point toward a new treatment approach that combines immunotherapy with surgery to control liver cancer and reduce recurrence.
What could go wrong
This is a very early Phase 1 trial with only 31 participants, so results may not apply broadly. Immunotherapies can cause serious side effects, and the added benefit of relatlimab is unknown.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: • Technically resectable HCC as defined by: * HCC may be diagnosed pathologically, or noninvasively by the American Association for the Study of Liver Diseases (AASLD) criteria or the Organ Procurement and Transplant Network (OPTN) Obligatory Diagnostic Criteria for Hepatocellular Carcinoma (HCC). No extrahepatic spread, no nodal disease, and no bilateral left and right branch portal vein involvement. * Measurable disease per RECIST 1.1 as determined by the investigator. * Age ≥ 18 years old on the day of consent. * ECOG performance status ≤1 or Karnofsky ≥80. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. * Patients must have adequate liver remnant and function. * Antiviral therapy per local standard of care for hepatitis B. * LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration. * Woman of child-bearing potential must have a negative pregnancy test. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Fibrolamellar carcinoma or mixed HCC. * Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC. * Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies. * Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial. * History of HIV infection. * Active co-infection with HBV and HDV. * Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * History of any autoimmune disease requiring systemic treatment within the past 2 years. * Systemic or topical corticosteroids at immunosuppressive doses (\> 10 mg/day of prednisone or equivalent). * Confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * Uncontrolled intercurrent illness.• * Uncontrolled or significant cardiovascular disease. * Significant heart disease. * Moderate or severe ascites. * Known or suspected hypersensitivity to study treatment. * Are pregnant or breastfeeding. * WOCBP and men with female partners (WOCBP) who are not willing to use contraception. * Unable to have blood drawn. * Any other sound medical, psychiatric, and/or social reason as determined by the Investigator. * Any illicit drugs or other substance abuse.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210-1002, United States

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