Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)
2 other identifiers
interventional
31
1 country
2
Brief Summary
The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started May 2021
Longer than P75 for phase_1 hepatocellular-carcinoma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
ExpectedDecember 18, 2025
December 1, 2025
4.3 years
December 1, 2020
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who complete pre-op treatment and proceed to surgery
4 years
Secondary Outcomes (12)
Number of participants experiencing study drug-related toxicities
4 years
Percentage of participants who obtain R0 resection
8 weeks
Percentage of evaluable patients who obtain a pathologic complete response (pCR) or major pathologic response (MPR)
8 weeks
Objective response rate (ORR) at 8 weeks
8 weeks
Overall survival (OS) at 12 months
12 months
- +7 more secondary outcomes
Study Arms (2)
Arm A - Nivolumab
EXPERIMENTALParticipants receive Nivolumab only.
Arm B - Nivolumab and Relatlimab
EXPERIMENTALParticipants receive Nivolumab and Relatlimab.
Interventions
Nivolumab 480mg will be administered as a 30 minute IV infusion (-/+15min) at cycle 1 day 1 and at cycle 2 day 1 (28 days) then every month for up to 12 months. Intravenous administration of Nivolumab (480 mg) will occur on Cycle 1 and 2 of the study then every 28 days up to a year. Nivolumab will be administered on Day 1 of each cycle for 10 doses/ months (whichever occurs first) for adjuvant.
Patients will receive 480 mg Relatlimab intravenously (-/+15min) on cycle 1 day 1 and at cycle 2 day 1 (every 28 days) for up to 1 year co-administered with Nivolumab.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210-1002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Yarchoan, MD
SKCCC Johns Hopkins Medical Institution
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 8, 2020
Study Start
May 28, 2021
Primary Completion
September 2, 2025
Study Completion (Estimated)
June 1, 2030
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share