Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma

NCT07365839 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-24-21103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of cemiplimab with or without fianlimab as measured by progression-free survival (PFS)

  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.

  Baseline, 6, 12, and 18 months, then every 6 months until off study up to 5 years

Secondary Outcomes (5)

• Evaluate the safety and toxicity profile of cemiplimab with or without fianlimab based on the number of patients experiencing grade greater than grade 3 treatment-related adverse events (TRAE).

  Baseline through 90 days following end of treatment (EOT) up to 5 years

• Assess the objective response rate (ORR) for patients receiving cemiplimab with or without fianlimab.

  6, 12, and 18 months

• Assess the progression free survival (PFS) rate for patients receiving cemiplimab with or without fianlimab

  6, 12, and 18 months, then every 6 months until off study up to 5 years

• Assess the median overall survival (OS) for patients receiving cemiplimab with or without fianlimab.

  6, 12 and 18 months then every 6 months until off study up to 5 years

• Assess the overall survival (OS) rate for patients receiving cemiplimab with or without fianlimab.

  6, 12 and 18 months, then every 6 months until off study up to 5 years

Study Arms (2)

Arm 1 Treatment with cemiplimab

EXPERIMENTAL

350 mg cemiplimab intravenous (IV) every 3 weeks

Drug: Arm 1 cemiplimab

Arm 2 Treatment with

EXPERIMENTAL

350 mg cemiplimab intravenous (IV) + 1600 mg fianlimab intravenous (IV) every 3 weeks

Drug: Arm 2 cemiplimab and fianlimab

Interventions

Arm 1 cemiplimab DRUG

Cemiplimab 350mg IV every 3 weeks up to 1 year.

Also known as: Libtayo, Anti-PD-1 antibody

Arm 1 Treatment with cemiplimab

Arm 2 cemiplimab and fianlimab DRUG

Cemiplimab 350mg IV and fianlimab 1600mg every 3 weeks up to 1 year

Also known as: Libtayo, Anti-PD-1 antibody & Anti-LAG-3 antibody

Arm 2 Treatment with

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hepatocellular carcinoma (HCC) in the liver by radiographic imaging or histology
• Eligible for yttrium-90 (Y90) treatment by the following definition:
• Patients must have lung dose threshold for Y90 glass microspheres of 30 Gy (≤ 30 Gy per treatment for glass) and an estimated future liver remnant volume (FLRV) ≥ 30% of whole liver volume
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Emily Kinsey, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

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: January 16, 2026
• First Posted: January 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 28, 2035
• Study Completion (Estimated): February 28, 2035
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)