Immunotherapy combo shows promise in early liver cancer trial
NCT ID NCT04658147
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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May 2021
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
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The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210-1002, United States
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