Cemiplimab +/- Fianlimab Post Y90 Radioembolization for Liver Cancer
This study is looking at how well two different treatments work for hepatocellular carcinoma (HCC), a type of liver cancer, after you've had Y90 radioembolization (a radiation treatment). You would either receive cemiplimab alone, or cemiplimab combined with fianlimab. Doctors want to see if these treatments can stop the cancer from growing or spreading. To join, you must have HCC, be eligible for Y90 treatment, and be at least 18 years old. The study will measure how long you live without your cancer getting worse (progression-free survival) over several years.
- Study design
- This is a randomized pilot study with 20 participants, comparing two treatment arms. It is not specified what phase the study is in.
- What's involved
- After Y90 treatment, you would receive your assigned study treatment every three weeks for up to one year, or until your disease progresses or you can't tolerate the treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured at baseline, 6, 12, and 18 months, then every 6 months until you are off study, for up to 5 years.
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NCT07365839
Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma
Withdrawn
PHASE1Ages 18+InterventionalTreatmentVirginia Commonwealth UniversityInvestigator-initiated
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Arm 1 cemiplimabArm 2 cemiplimab and fianlimab
At a glance
Recruiting sites
Site status isn't published for this study.
What they're measuring
Assess the efficacy of cemiplimab with or without fianlimab as measured by progression-free survival (PFS)
Measured over Baseline, 6, 12, and 18 months, then every 6 months until off study up to 5 years
Conditions
Study leadership
- Emily Kinsey, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Diagnosis of hepatocellular carcinoma (HCC) in the liver by radiographic imaging or histology
Eligible for yttrium-90 (Y90) treatment by the following definition:
Age ≥18 years
Disease in the liver measurable by modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Child Pugh Scale Score A-B7
Not eligible for (according to the practice of the treating institution) or declined the following treatments:
surgical resection
immediate liver transplantation
thermal ablation
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Troponin (TnT and TnI) ≤1 × upper limit of normal (ULN) at baseline Note: Patients with TnT or TnI levels between \>1 to 2 × ULN are permitted if repeat levels within 24 hours are ≤1 × ULN. If TnT or TnI levels are \>1 to 2 × ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
Alkaline phosphatase ≤5 × ULN
Aspartate aminotransferase (AST) ≤5 × ULN
Alanine transaminase (ALT) ≤5 × ULN
Creatinine clearance \>30 mL/min (actual or calculated per the Cockcroft-Gault formula)
Bilirubin ≤2 milligram/ deciliter (mg/dL) Exception: If a patient has documented Gilbert's syndrome and a total bilirubin is ≥2 mg/dL, the total bilirubin requirement may be waived provided the direct bilirubin is within normal limits (WNL)
Patients with known Human immunodeficiency virus (HIV) infection are eligible if the following conditions are met:
the HIV is well controlled with no AIDS-related complications
undetectable viral load
Cluster of Differentiation 4 (CD4)+ T-lymphocyte count(T-cell) above 350 cells/microliters (μL) Note: HIV testing is not required for study participation.
Patients with known active hepatitis B virus (HBV) infection are eligible if the following conditions are met:
serum HBV Deoxyribonucleic Acid (DNA) polymerase chain reaction ( PCR)below the limit of detection
receiving anti-HBV treatment Note: HBV testing for diagnosis is not required for study entry. Determination of known active HBV infection is based on medical history.
Patients with known chronic hepatitis C virus (HCV) infection are eligible if they have undetectable HCV RNA by PCR Note: HCV testing for diagnosis is not required for study entry. Determination of known chronic HCV infection is based on medical history. Receipt of anti-HCV medication has no bearing on study eligibility.
Patients with HIV or hepatitis must have established longitudinal care with a qualified specialist (eg, infectious disease or hepatologist).
Stable use of combined (estrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception (oral, injectable, or implantable) associated with inhibition of ovulation initiated 8 weeks before the screening serum beta-hCG test
Intrauterine device (IUD); intrauterine hormone-releasing system (IUS)
Vasectomized partner, provided that the male vasectomized partner is the sole male sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure
Sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs, if evaluated by the treating investigator to be reliable in relation to the duration of required contraception (up to 18 months) and the preferred and usual lifestyle of the participant.
WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and for at least 6 months after the last dose of study treatment
Male study participants with WOCBP partners are required to use condoms during the entire trial and for at least 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.
Vasectomized study participants must have received medical assessment of surgical success for the procedure.
Sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs, must be evaluated by the treating investigator to be reliable in relation to the duration of required contraception (up to 18 months) and the preferred and usual lifestyle of the participant.
Male study participants must agree not to donate sperm during the entire trial and for at least 6 months after the last dose of study treatment
Known hypersensitivity to the active substances or to any of the excipient
Received a live vaccine within 30 days before the planned start of study medication. Note that this applies to live or live attenuated vaccination with replicating potential
Prior history of interstitial lung disease or pneumonitis
Exclusion
Any history of invasive malignancy within the past 3 years, except for the following:
adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, breast ductal carcinoma in situ, low-grade endometrial carcinoma, or in situ cervical cancer,
localized prostate cancer under active surveillance or gonadotropin-releasing hormone (GNRH) therapy
treating physician determines previous cancer has been adequately treated with high probability for cure (as documented in medical record)
Presence of extrahepatic disease Note: non measurable (\<1 centimeter (cm)) lesions outside the liver are acceptable if they do not represent a deterrent for Y90 treatment per the standards of the treating institution
Receipt of more than 1 prior embolization (TACE or Y90) treatment/procedure
Portal vein thrombosis (PVT) Vp3 or Vp4
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (except viral hepatitis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or myocarditis
Current enrollment in any other investigational therapeutic drug study
Currently breastfeeding
Recipient of an organ transplant, including bone marrow allogeneic transplant
Previous systemic therapy for HCC
Ongoing or recent (within 2 years) autoimmune disorder except for the following:
Vitiligo
Alopecia
Hashimoto's thyroiditis
Celiac disease controlled by diet
Chronic skin conditions that do not require systemic therapy
Childhood asthma that has resolved
Residual hypothyroidism that requires only hormone replacement
Use of immunosuppressive medication within 14 days before the first dose of study treatment, except the following:
include topical, inhaled, local injection or intranasal steroids
systemic steroids at doses of ≤10 mg/day of prednisone (equivalent)
steroids for premedication
TnT or troponin I TnI ≥ 2 × ULN at baseline
History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks before the first dose of study treatment
What this trial measures
- Assess the efficacy of cemiplimab with or without fianlimab as measured by progression-free survival (PFS)Baseline, 6, 12, and 18 months, then every 6 months until off study up to 5 years
Progression-free survival, defined as the number of days from the start date of Y90 treatment (administered two times) to the date of progression, relapse, or death.