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 clinically confirmed to have head and neck cancer that has either come back (recurrent) or spread to other parts of the body (metastatic).
• People who have not previously received whole-body (systemic) treatments for their recurrent or metastatic cancer. Systemic treatment given more than 3 months ago as part of treatment for locally advanced disease is generally allowed.
• People aged 18 or older.
• People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity — confirm with trial site).
• People whose cancer can be measured on scans using standard criteria (RECIST 1.1), including tumors in previously treated areas if the cancer has continued to grow there.
• People whose organ function (such as liver, kidneys, and bone marrow) falls within normal ranges on blood tests.
• People who have provided a tissue sample (core or excisional biopsy — not a fine needle sample) for a specific protein test called PD-L1. A recently obtained sample (within 90 days before starting treatment) is strongly preferred, though an older stored sample may be acceptable.
• People who are willing and able to sign a written informed consent form before entering the study.
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting the study treatment.
• Women who could become pregnant must agree to use contraception throughout the duration of treatment.
• Men who are sexually active with women who could become pregnant must agree to use contraception throughout the duration of treatment.

Who may not be able to join:

• People whose cancer could potentially be treated with local therapy (such as surgery or radiation) aimed at curing the disease.
• People whose cancer got worse within 3 months of finishing a curative treatment course for locally advanced head and neck cancer.
• People who are currently taking part in another clinical trial involving an investigational (unapproved/experimental) treatment.
• People whose cancer cannot be detected by a specific blood test called Signatera ctDNA at the start of the study.
• People who have had radiation therapy or other non-systemic treatments within 2 weeks before enrolling, or who have not fully recovered from side effects of a previous treatment. (Note: People with mild ongoing nerve-related side effects or mild hair loss may still be considered — confirm with trial site. People who have had major surgery must have adequately recovered before starting.)
• People who have an active or suspected immune system disorder that requires immune-suppressing medication, with some exceptions (such as people with vitiligo, stable thyroid conditions managed with hormone replacement, or minor skin conditions not needing systemic treatment, or those on very low-dose steroids of 10mg or less of prednisone or equivalent).
• People who, in their treating doctor's opinion, have a life expectancy of less than 3 months or whose disease is rapidly progressing (for example, with tumor bleeding or uncontrolled pain).
• People who currently have another active cancer, other than certain common non-serious skin cancers. People who have completed treatment for a prior cancer and have been disease-free for 3 or more years are generally not considered to have an "active" second cancer.
• People with known cancer spread to the brain (brain metastases).
• People who have previously received an organ or tissue transplant from another person.
• People with a history of serious allergic reactions to pembrolizumab or to drugs with similar chemical or biological makeup to those used in this study.
• People who have previously been treated with a type of immunotherapy drug called an anti-PD-1 therapy.
• People with uncontrolled ongoing illness, including active serious infections, heart failure, unstable chest pain, irregular heartbeat, or mental health or social situations that would make it difficult to follow the study requirements.
• People with a history of lung inflammation (pneumonitis) that previously required steroid treatment, or who currently have pneumonitis.
• People who are pregnant.
• People who are breastfeeding.
• People who are HIV-positive and on combination antiretroviral therapy.
• People with currently active Hepatitis B or Hepatitis C infection. (People who have previously had and fully cleared either infection may still be considered — confirm with trial site.)
• People with a history of a serious active infection that required treatment with systemic medications.
• People who have received a live vaccine within 28 days before the planned start of study treatment. (Note: approved COVID-19 vaccines are generally allowed, except any live COVID-19 vaccine that may be developed — confirm with trial site.)

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