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 had a return of head and neck squamous cell cancer (or a new primary cancer) in an area of the body that was previously treated with radiation at a dose of 50 Gray or more.
• People whose cancer affects the mouth, throat (oro- or hypopharynx), or voice box (larynx, but only if the cancer has spread beyond the larynx), or who have cancer that has come back only in the lymph nodes of the neck.
• People who have had surgery to remove the cancer with the goal of curing it, and where all visible cancer was fully removed.
• People whose cohort (group) had surgery more than 6 months after their original radiation treatment (cohorts 1 and 2), or less than 6 months after (cohorts 1bis and 2bis) (confirm with trial site).
• People whose cancer came back in a way that is considered high-risk — for example, because it grew into surrounding tissue, the lymph node involvement was 3 cm or larger, or both local and lymph node recurrence occurred at the same time.
• People whose cancer appeared less aggressive on the surface, but where the removed tissue showed high-risk features under the microscope — such as cancer cells at or very close to the surgical edges, cancer spreading along nerves or into blood vessels, multiple affected lymph nodes, or a lymph node where the cancer has broken through the node's outer covering.
• People who have healed well enough to start additional treatment within approximately 8 weeks of their surgery.
• People with no cancer spread to distant parts of the body, confirmed by CT or PET scan.
• People aged 18 to 75 years (inclusive).
• People with a good general level of physical functioning (able to carry out normal daily activities, with at most some restriction in physically demanding activity) (confirm with trial site).
• People who have stopped taking high-dose steroid or immunosuppressive medications at least 2 weeks before starting the trial treatment.
• People whose recent blood test results (taken within 14 days of starting treatment) meet the required levels for blood cells, liver function, kidney function, and other markers (confirm with trial site for specific values).
• Women who could become pregnant must have a negative pregnancy blood test within 24 hours before starting treatment.
• Women who could become pregnant and are sexually active must agree to use highly effective contraception, or abstain from sexual activity, during the trial and for at least 5 months after the last treatment.
• Male participants who are sexually active must agree to use a condom during the trial and for at least 7 months after the last treatment, and it is recommended that their partner also use highly effective contraception if they could become pregnant.
• Women who are breastfeeding must stop breastfeeding before the first dose and for at least 5 months after the last dose.
• People who are able to understand, agree to, and sign the informed consent form before any trial procedures begin, and who are willing and able to attend study visits and follow the trial procedures.
• People who are enrolled in a social security or equivalent health coverage system (as required in the country where the trial is conducted).

Who may not be able to join:

• People whose cancer is a recurrence or spread of nasopharyngeal cancer, skin-based squamous cell carcinoma, salivary gland cancer, or any non-squamous cell cancer type (such as mucosal melanoma).
• People whose cancer has come back in an area that was not previously treated with radiation, or was treated with a radiation dose below 50 Gray.
• People whose surgery did not fully remove all visible cancer (partial removal is not permitted).
• People whose cancer returned only as a superficial (surface-level) recurrence with no lymph node involvement and no high-risk features found in the removed tissue under the microscope.
• People whose cancer returned only in a lymph node smaller than 3 cm, with no local recurrence and no evidence that the cancer broke through the outer wall of the lymph node.
• People with serious medical conditions affecting the heart, lungs, or liver (the trial site will assess this individually).
• People with an active autoimmune disease (a condition where the immune system attacks the body), with some exceptions for milder or stable autoimmune conditions such as vitiligo, type 1 diabetes, thyroid conditions managed with hormone replacement only, or psoriasis not requiring systemic treatment.
• People who need ongoing treatment with corticosteroids above 10 mg per day (prednisone equivalent) or other medicines that suppress the immune system, within 14 days of starting the trial drug (inhaled or topical steroids, and low-dose replacement steroids, may be allowed in certain circumstances — confirm with trial site).
• People who test positive for active or chronic hepatitis B or hepatitis C infection.
• People who test positive for HIV or who have AIDS.
• People who have had another cancer that was active within the past 3 years, except for certain easily treated cancers that appear to have been fully cured, such as some skin cancers, early bladder cancer, or non-invasive cancers of the prostate, cervix, or breast.
• People who have previously been treated with certain immune checkpoint or T-cell targeting therapies, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or similar drugs.
• People who have received other cancer treatments within 4 weeks before starting the trial drug, or who received palliative radiation or high-dose steroid treatment within 2 weeks before starting; any side effects from prior cancer treatment (other than hair loss or fatigue) must have settled to a mild or stable level beforehand.
• People who have received a live-virus vaccine within 4 weeks before starting the trial drug (inactivated flu vaccines are permitted).
• People with an existing medical condition that, in the trial doctor's opinion, would make receiving the study drug unsafe or make it difficult to assess side effects (confirm with trial site).
• People who require ongoing treatment with full therapeutic doses of blood-thinning (anticoagulant) medication (low-dose anticoagulants for clot prevention may be allowed — confirm with trial site).
• People with a history of autoimmune or immune-related inflammatory conditions, including but not limited to colitis, lung inflammation, liver inflammation, kidney inflammation, skin inflammation, or inflammation affecting the nervous system, eyes, or hormone-producing glands.
• People with a currently active serious infection, particularly one being treated with antibiotics or antimicrobial medications.
• People who have had a severe allergic reaction to any monoclonal antibody treatment in the past.
• People who have a known allergy to any component of the study drugs.
• People who are currently taking part in another clinical trial or received an investigational treatment within the past 4 weeks.
• People who are pregnant or breastfeeding.
• People for whom psychological, family, or social circumstances would make it difficult to give informed consent or attend regular follow-up appointments.
• People who have previously received a donor stem cell transplant or a solid organ transplant.

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