Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Dec 1, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the use of two medications, Nivolumab and Relatlimab, to see how safe and effective they are for patients with a type of liver cancer called hepatocellular carcinoma (HCC) that can potentially be removed with surgery. The study is currently looking for participants aged 18 and older who have specific characteristics, such as having liver cancer that hasn’t spread beyond the liver and having enough healthy liver function.

If you or a loved one is eligible to participate, you can expect to receive either Nivolumab alone or Nivolumab combined with Relatlimab before and after surgery. Throughout the trial, the medical team will closely monitor your health to ensure the treatments are safe and to understand how well they work. It’s important to note that participants will need to meet certain health criteria and may need to follow specific guidelines regarding other medical conditions and medications.

Gender

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Eligibility criteria

• 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.