Cemiplimab for Treating Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Sponsor: Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05929664

Provider View

This study is testing how well the drug cemiplimab works in shrinking basal cell carcinoma in the head and neck area before surgery. The goal is to make the tumor smaller and easier to remove by boosting the immune system's ability to fight cancer cells.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of cemiplimab, a drug that may help the immune system attack cancer cells, in treating basal cell carcinoma of the head and neck that has spread to nearby tissues or lymph nodes. The treatment is given before surgery to potentially reduce the size of the tumor, making it easier to remove.

Description

PRIMARY OBJECTIVE:

  • To evaluate how well cemiplimab works in shrinking advanced basal cell carcinoma (BCC) in the head and neck before surgery.

SECONDARY OBJECTIVES:

  • To see if cemiplimab helps preserve the function of organs affected by the cancer.
  • To assess the response of the tumor to the treatment.
  • To monitor the safety of cemiplimab when used before surgery.
  • To evaluate any changes in the quality of life of patients.

EXPLORATORY OBJECTIVE:

  • To study changes in the immune system related to the treatment.

OUTLINE:

Patients will receive cemiplimab through an IV infusion over 30 minutes on the first day of each treatment cycle. The treatment is repeated every 21 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable. If the cancer progresses, patients may switch to standard treatment with a hedgehog inhibitor. Throughout the trial, patients will have CT or MRI scans and blood samples taken. Biopsies will be done during screening and during the study.

After completing the study treatment, patients will have follow-up visits at 3 months and 6 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced basal cell carcinoma (BCC) of the head and neck that requires significant surgery.
  • Tumor involvement of specific areas such as the nose, lips, ear, eyelid, facial nerve, or orbit, meeting certain criteria.
  • Male or female, aged 18 years or older.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 6 months.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
  • Men must use contraception if sexually active with women of childbearing potential.
  • Ability to understand and sign a written informed consent document.

Exclusion Criteria

  • Recent radiation therapy for the target cancer within the past 6 months.
  • Allergy to the study drug components.
  • Other active cancers, except for certain types that have been treated.
  • Unresolved side effects from previous cancer treatments, except for certain conditions.
  • Need for systemic treatment with corticosteroids or other immunosuppressive medications.
  • Significant connective tissue disorders.
  • Participation in other investigational drug studies.
  • Recent receipt of a live vaccine.
  • Uncontrolled illnesses or infections, including active TB, hepatitis B or C, or HIV.
  • Previous treatment with immunotherapy or hedgehog inhibitors for cancer.
  • Untreated active brain metastases.
  • History of lung inflammation (pneumonitis) within the past 5 years.

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