Study on Cemiplimab Before Surgery for Treating Resectable Lung, Liver, and Head and Neck Cancers in Adults

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03916627

Provider View

This clinical trial is exploring whether the drug cemiplimab, alone or combined with another experimental drug, fianlimab, can effectively treat certain cancers before surgery. The study aims to understand how these drugs work, their safety, and any side effects they may cause.

Patient Parameters

Program Overview

The purpose of this study is to see if cemiplimab, either by itself or with another drug called fianlimab, can help treat certain types of cancer before surgery. Cemiplimab and fianlimab are both monoclonal antibodies, which are special proteins designed to target specific parts of cancer cells. Cemiplimab works by blocking a receptor on immune cells, while fianlimab blocks a protein involved in cancer growth. The study will look at how well these drugs work, their safety, and any side effects they might cause.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), or head and neck squamous cell carcinoma (HNSCC).
  • Be willing to provide blood samples at specific times during the study.
  • Be willing to have a biopsy of the tumor before starting cemiplimab treatment.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Be a candidate for surgery to remove the tumor.
  • Have adequate organ and bone marrow function as specified in the study.

Exclusion Criteria

  • Have received any cancer treatment or radiation therapy within the last 6 months for the current or a different tumor.
  • Have a tumor that is growing too quickly to delay surgery, as determined by the study doctor.
  • Have participated in another study with an experimental drug or device within the last 4 weeks or longer, depending on the drug's half-life.
  • Have had major surgery within 14 days before starting the study treatment.
  • Have cancer that has spread to other parts of the body, where surgery would not be curative.
  • Have uncontrolled illness, as determined by the study doctor.
  • Are taking steroids or other immune-suppressing medications within 7 days before the first dose of the study treatment.
  • Have an active autoimmune disease that required treatment in the past year.
  • Have another progressing cancer that requires treatment, except for certain skin cancers or other specific conditions.
  • Have had brain inflammation, meningitis, or uncontrolled seizures in the past year.
  • Have a history of certain lung diseases or active lung inflammation that required treatment with steroids.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections, or a diagnosis of immunodeficiency.
  • For NSCLC patients: Do not have a history of smoking (defined as smoking at least 100 cigarettes in a lifetime).
  • For NSCLC patients: Have tumors with specific genetic mutations (EGFR, ALK, or ROS1).

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