Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed (through laboratory testing of a tissue or cell sample) with head and neck squamous cell cancer that has come back, specifically in the mouth, voice box, lower throat, or the back of the throat (HPV-negative type only).
• People whose doctors consider them suitable for surgery to remove the cancer.
• People whose cancer returned more than 6 months after a previous course of radiation therapy, where the area now affected received at least 30 Gy of radiation.
• People whose cancer is in one area, or in closely connected areas, that can be treated as a single region, and where the total tumour size is less than 7 cm.
• People whose tumour tissue tests positive for a protein called PD-L1, with a score of at least 1% — this can be tested on a new biopsy or stored tissue samples.
• People aged 18 or older.
• People who are generally well enough to carry out most daily activities with minimal limitations (confirm with trial site for the specific fitness score required).
• People whose blood tests show that their liver, kidneys, and bone marrow are working at an adequate level (confirm with trial site for the specific numbers required).
• People who have stored tumour tissue available — either a tissue block or at least 20 prepared slides.
• People living with HIV who are on effective treatment and have had an undetectable level of virus in their blood within the last 6 months.
• People with a long-term hepatitis B infection who are on suppressive treatment and have an undetectable level of the virus in their blood.
• People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable virus level.
• People who have had, or currently have, another type of cancer that is not expected to interfere with this trial's treatment or assessments.
• People with a history of heart problems or prior treatment with heart-affecting medications, where a doctor's assessment of heart function places them in a suitable category (class 2B or better on a standard heart function scale).
• People who are able and willing to use effective contraception throughout the trial and for 4 months after the last dose of the study drug — this applies to both women who could become pregnant and to men; pregnancy must be reported to the treating doctor immediately if it occurs.
• People who are able to understand the trial and are willing to sign a consent form; a legal representative may sign on someone's behalf if needed.

Who may not be able to join:

• People whose cancer has spread to other parts of the body (metastatic disease).
• People who are still experiencing significant side effects from previous cancer treatments that could prevent them from completing this trial's treatment, in the opinion of the treating doctors.
• People who are currently taking part in another clinical trial using an investigational treatment (those who have previously done so but are no longer receiving that treatment may be considered, at the lead doctor's discretion).
• People who have received a type of immunotherapy drug called a PD-1 inhibitor within the last 6 months, or whose cancer got worse while on a PD-1 inhibitor at any point in the past.
• People who have an autoimmune disease or other ongoing inflammatory condition, apart from well-controlled, stable conditions such as asthma, minor allergies, vitiligo, or an underactive thyroid.
• People who are regularly taking steroid medication at a dose greater than 10 mg of prednisone per day, unless the steroid is used in a form that stays local to one area of the body, such as an inhaler or a skin cream.
• People with other serious uncontrolled health conditions that, in the doctor's opinion, would make participation unsafe.
• People who are pregnant; people who are breastfeeding are also excluded, as the study drug may pose a risk to nursing infants.

Important: Always verify eligibility with the trial site directly before applying.