Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 (confirmed by laboratory tissue analysis) with a serious form of skin cancer called invasive cutaneous squamous cell carcinoma (cSCC) that is at an advanced local stage, has been assessed before surgery as high-risk, and where the medical team recommends radiation therapy after surgery, and where complete surgical removal is considered possible.
• People whose cancer can be measured according to standard research criteria (called RECIST 1.1), including in areas previously treated with radiation if the cancer has grown there.
• People who are in good enough general health to carry out daily activities with little to no limitation, as assessed within 10 days before starting treatment (confirmed with trial site).
• People whose major organs (such as kidneys, liver, and blood cells) are functioning adequately.
• People who are able to provide a tissue sample suitable for research, either from a new biopsy or existing tissue.
• People who have a life expectancy of more than 6 months.
• People who are 18 years of age or older at the time of signing the consent form.
• Female participants who are not pregnant, not breastfeeding, and who either cannot become pregnant or agree to use adequate contraception during the trial and for at least 120 days after the last dose of treatment.
• People who are willing and able to give written consent to take part in the trial.

Who may not be able to join:

• People whose cSCC has spread to other parts of the body or cannot be removed by surgery, radiation, or a combination of both.
• People whose primary skin cancer is a type other than invasive squamous cell carcinoma — for example, basal cell carcinoma that has not been fully treated, Bowen's disease, Merkel cell carcinoma, or melanoma.
• People who have previously received a solid organ transplant or a stem cell transplant from another person.
• People who have previously been treated with certain immunotherapy drugs that target the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents).
• People who have previously received any systemic anti-cancer treatment (including experimental treatments) for cSCC.
• People who have previously received radiation therapy to the area of cancer being studied in this trial.
• People who have received a live vaccine (such as measles, chickenpox, yellow fever, or nasal flu spray) within 30 days before the first dose of the trial drug.
• People who are currently taking part in, or have recently taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks.
• People who have a significant autoimmune disease that has been active or required treatment with immune-suppressing medications within the past 2 years, or who have a condition affecting the immune system such as HIV or a blood cancer associated with immune suppression.
• People who are currently taking steroid medications at a dose higher than the equivalent of 10 mg of prednisone per day, or any other immune-suppressing medication, within 7 days before the first dose of the trial drug.
• People who have been diagnosed with or treated for another cancer within the past 3 years (some exceptions may apply — confirm with trial site).
• People who have an active autoimmune disease that has required systemic medical treatment in the past 2 years (hormone replacement or similar supportive therapies are generally not considered exclusionary — confirm with trial site).
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People who have an active infection that requires treatment through the bloodstream (such as intravenous antibiotics).
• People with a known history of active Hepatitis B or Hepatitis C infection.
• People with a known mental health condition or substance use disorder that would make it difficult to meet the requirements of the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 120 days after the last dose of the trial treatment.

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