Study on Cemiplimab and Cetuximab Before Surgery for Recurrent Oral Cavity Squamous Cell Carcinoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06448026

Provider View

This clinical trial is exploring whether using the drugs cemiplimab and cetuximab before surgery can help control oral cavity squamous cell carcinoma that has returned after initial treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if giving the drugs cemiplimab and cetuximab before surgery can help manage oral cavity squamous cell carcinoma that has come back after previous treatment. Researchers are also looking at the safety of these drugs and how they affect surgery and follow-up treatments. They will also study how long patients remain free of disease and their overall survival rates.

Description

The main goal of this study is to see how effective cemiplimab and cetuximab are in treating patients with recurrent oral cavity squamous cell carcinoma. Researchers will also evaluate the safety of these drugs when given before surgery and measure their impact on the surgery and any additional treatments needed afterward. They will estimate how long patients stay free of the disease and their overall survival time. Additionally, the study will explore how patients feel during treatment and look for biological markers that might predict how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed recurrent oral cavity squamous cell carcinoma.
  • Eligible for surgery to remove the cancer.
  • Cancer has returned at least 3 months after finishing initial treatment, which may have included surgery, radiation, or chemotherapy.
  • Cancer can be measured using standard criteria.
  • Good overall health with a performance status score of 0 or 1.
  • Willing to have a biopsy if a previous tumor sample is not available.
  • Blood tests showing:
    • Hemoglobin level of at least 9 g/dL (blood transfusions allowed to meet this level).
    • Neutrophil count of at least 1 x 10^9/mL.
    • Platelet count of at least 80 x 10^9/mL.
  • Kidney function with creatinine clearance of at least 30 mL/min.
  • Liver function with AST and ALT levels no more than 3 times the upper limit of normal, and bilirubin levels within specified limits.
  • Women of childbearing potential must use two effective forms of birth control during treatment and for 90 days after.
  • Men must agree to use contraception during treatment and for 90 days after.

Exclusion Criteria

  • Cancer returned within 3 months after finishing initial treatment.
  • Cancer has spread to distant organs or lymph nodes.
  • Previous treatment with anti-PD1/PD-L1 drugs.
  • Need for corticosteroid therapy over 10 mg of prednisone per day within 14 days before starting the study, unless for non-immunosuppressive reasons.
  • Active autoimmune disease requiring treatment within the last 5 years, with some exceptions.
  • History of lung diseases like interstitial lung disease or pneumonitis needing treatment.
  • Previous organ or stem cell transplants.
  • Other cancers treated with curative intent within the last 5 years, with some exceptions.
  • Active infections needing treatment within 10 days before starting the study, unless viral load is undetectable.
  • Medical conditions that increase risk, such as recent heart attack, unstable angina, uncontrolled diabetes, or severe heart failure.
  • Pregnant or breastfeeding women.
  • Allergies to study drugs or their components.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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