ACTIVE_NOT_RECRUITING

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

Conditions

Hepatocellular Carcinoma Relatlimab Nivolumab Immunotherapy Anti PD-1 Anti - LAG-3 Resectable hepatocellular Cancer Potentially resectable hepatocellular Cancer Hepatocellular Cancer (HCC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.

Official Title

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

Quick Facts

Study Start:2021-05-28

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04658147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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). * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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).
* 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.

* 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.

Contacts and Locations

Principal Investigator

Mark Yarchoan, MD

PRINCIPAL_INVESTIGATOR

SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231

United States

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210-1002

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Mark Yarchoan, MD, PRINCIPAL_INVESTIGATOR, SKCCC Johns Hopkins Medical Institution

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-28

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2021-05-28

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Relatlimab
Nivolumab
Immunotherapy
Anti PD-1
Anti - LAG-3
Resectable hepatocellular Cancer
Potentially resectable hepatocellular Cancer
Hepatocellular Cancer (HCC)

Additional Relevant MeSH Terms

Hepatocellular Carcinoma