Study on Cemiplimab for Treating Recurrent and Removable Stage II-IV Head and Neck Skin Cancer Before Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03565783

Provider View

This clinical trial is testing how well the drug cemiplimab works when given before surgery to treat patients with stage II-IV head and neck skin cancer that has returned and can be surgically removed. Cemiplimab is an immunotherapy that may help the immune system attack cancer cells and stop them from growing and spreading.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of cemiplimab, an immunotherapy drug, in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back and can be removed by surgery. The drug is given before surgery to see if it can help the body's immune system attack the cancer and prevent it from growing and spreading.

Description

The main goal of this study is to find out how well cemiplimab works in shrinking tumors in patients with stage II-IV head and neck skin cancer before they undergo surgery. Researchers will use specific criteria to measure the response to the treatment.

Secondary goals include:

  • Assessing the safety and side effects of cemiplimab when used before surgery.
  • Estimating the survival rates and time without disease after two years compared to past data.
  • Understanding how the treatment affects certain immune markers in the cancer.

Patients will receive cemiplimab through an IV every three weeks, for up to six weeks, possibly along with radiation therapy, depending on the doctor's decision. After finishing the treatment, patients will be monitored for 30 days and then periodically for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage II-IV head and neck skin cancer that can be surgically removed.
  • Surgery planned as the main treatment, with or without additional radiation therapy.
  • Previous surgery allowed if cancer has returned and it's been more than four weeks since surgery.
  • Must be 18 years or older.
  • Meet specific blood count and organ function requirements.
  • Have measurable disease based on specific criteria.
  • Be in good overall health with a performance status of 0 or 1.
  • No evidence of cancer spread to distant parts of the body.
  • Willing to sign informed consent and follow study requirements.

Exclusion Criteria

  • Recent cancer treatments like chemotherapy or radiotherapy within three weeks before starting the study.
  • Unresolved side effects from previous cancer treatments.
  • Certain types of blood cancers or active infections.
  • Pregnant or breastfeeding women.
  • Known allergies to specific drug components.
  • History of autoimmune diseases or severe allergic reactions.
  • Recent major surgery or live vaccinations.
  • Other cancers within the last five years, except for certain non-threatening types.
  • Not willing to use effective contraception during the study and for six months after.
  • Previous treatment with similar immunotherapy drugs.
  • Use of certain medications that affect the immune system within two weeks before starting the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.