J20121: Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients with Potentially Resectable Hepatocellular Carcinoma (HCC)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Brief Summary
Nivolumab or nivolumab and relatlimab will be administered every 4 weeks on an outpatient basis. Patients will receive 2 doses of therapy (8 weeks), prior to surgical resection, and then can continue treatment after surgery to complete a year of therapy.
Eligibility
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.