Study on Immunotherapy and Targeted Radiation for Head and Neck Cancer

Sponsor: Medical College of Wisconsin

Sponsor score: 0

ClinicalTrials ID:NCT07773987

Provider View

This clinical trial is exploring a new treatment approach for head and neck cancer using immunotherapy and targeted radiation before surgery. The study aims to see if this combination can improve the body's immune response to the cancer.

Patient Parameters

Program Overview

This study is testing a new treatment method for patients with head and neck cancer that can be surgically removed. It involves using a combination of immunotherapy (a drug called pembrolizumab) and targeted radiation therapy before surgery. The goal is to see if this approach can help the immune system better recognize and attack the cancer cells. Patients will receive two cycles of pembrolizumab, followed by radiation therapy, and then two more cycles of pembrolizumab before having surgery. Some patients will also receive additional radiation to nearby lymph nodes. The study will monitor symptoms and collect tumor samples at different stages to understand how the treatment affects the cancer.

Description

Patients with head and neck cancer that can be surgically removed and who have not had previous radiation to the head and neck can participate in this study. The treatment involves receiving pembrolizumab, an immunotherapy drug, before and after radiation therapy. The radiation is given in five sessions to target the cancer directly. Some patients will also receive radiation to nearby lymph nodes. After the radiation, patients will have surgery to remove the cancer. The study will use surveys to assess symptoms and collect tumor samples at different times to study the effects of the treatment. If patients agree, additional MRI scans will be done to provide more information about the cancer's response to treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a type of head and neck cancer that can be surgically removed, specifically squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx.
  • Cancer must be advanced, as determined by specific medical criteria.
  • Have a CPS score of at least 1 from an initial biopsy.
  • Be in good overall health with a performance status score between 0 and 2.
  • Women must not be pregnant and must agree to use effective contraception during and after the study. Men must also agree to use contraception.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have HPV-positive squamous cell carcinoma of the oropharynx.
  • Tumor cannot be accessed for a biopsy.
  • Have had a solid organ transplant requiring ongoing immunosuppression.
  • Have an autoimmune disease requiring steroids or other immunosuppressive drugs.
  • Have had another invasive cancer within the past 3 years, except for certain early-stage cancers.
  • Have a life expectancy of less than 12 months.
  • Have a performance status score of 3 or higher.
  • Have had previous radiation therapy to the head and neck that overlaps with the study treatment area.
  • Have had previous systemic therapy for the study cancer.
  • Weigh 30 kg or less.
  • Have severe laboratory abnormalities that are not corrected before the study.
  • Have unstable heart conditions or recent heart attacks.
  • Have medical or psychiatric conditions that would interfere with treatment or study participation.
  • Women who are pregnant or breastfeeding, and men and women who are not willing to use contraception during and after treatment.

Locations

FACILITYZIPCITYSTATE
Froedtert & the Medical College of Wisconsin53226MilwaukeeWisconsin

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