Cetuximab After Immunotherapy for Treating Head and Neck Squamous Cell Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04375384

Provider View

This clinical trial is testing the effectiveness of Cetuximab, a medication given alone, for patients with head and neck squamous cell cancer that has returned or spread after previous immunotherapy treatments.

Patient Parameters

Program Overview

This Phase II clinical trial is designed to see how well Cetuximab works when given by itself to patients with head and neck squamous cell cancer that has come back or spread after failing to respond to immunotherapy or a combination of immunotherapy and chemotherapy. The study is open-label, meaning both doctors and patients know what treatment is being given, and non-randomized, so all participants receive the same treatment.

Description

The main goal of this study is to measure how well patients respond to Cetuximab when used alone, after their cancer did not respond to PD-1 inhibitors, which are a type of immunotherapy, either alone or with chemotherapy.

Secondary goals include:

  • Measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival rates.
  • Evaluating the side effects of Cetuximab in this group of patients.

Patients in the study will receive Cetuximab through an IV infusion over 60 to 120 minutes once a week, as long as the cancer does not progress or side effects are manageable. After finishing the treatment, patients will have follow-up visits one week later and then every 6 to 8 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of head and neck squamous cell carcinoma.
  • Must have at least one tumor that can be measured by scans.
  • Must have previously been treated with PD-1 inhibitor immunotherapy, alone or with chemotherapy.
  • Must have a performance status score between 0 and 2, indicating good overall health.
  • Must be 18 years or older.
  • Must agree to provide blood and saliva samples at scheduled times during the study.
  • Must be willing to follow the study protocol and sign a consent form.

Exclusion Criteria

  • Have had previous treatment with Cetuximab or drugs targeting the EGFR pathway.
  • Have had an allergic reaction to Cetuximab or similar drugs.
  • Are taking other investigational drugs.
  • Are on medications that may interact with Cetuximab and cannot be stopped.
  • Have any uncontrolled medical conditions that could interfere with the study.
  • Have a history of lung diseases like pneumonitis or pulmonary fibrosis.
  • Have serious or non-healing wounds, ulcers, or bone fractures.
  • Have had certain medical events like a stroke, heart attack, or blood clots within specific timeframes before the study.
  • Are pregnant, breastfeeding, or planning to conceive during the study and for 6 months after the last treatment.

Get This Program In Your Inbox

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