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 aged 18 or older who have given written, voluntary agreement to take part in the study and are willing and able to attend scheduled visits and follow the study plan.
• People who have been diagnosed with squamous cell carcinoma of the head and neck, confirmed by a tissue sample (biopsy).
• People whose cancer started in one of these areas: the oropharynx (back of the throat), oral cavity (mouth), hypopharynx (lower throat), or larynx (voice box).
• People with oropharyngeal cancer whose HPV (Human Papillomavirus) status has been tested and is known.
• People whose cancer has continued to grow or spread (progressed) during or after receiving platinum/5-FU chemotherapy combined with pembrolizumab as their first treatment for recurrent or metastatic disease, with measurable disease visible on a CT or MRI scan.
• People who are able to provide a tumour tissue sample (biopsy) before starting the study treatment — a fresh biopsy taken after the previous treatment stopped working is strongly preferred, though an older stored sample may be acceptable after discussion with the trial team (fine needle aspirate samples are not acceptable).
• People who are reasonably well and able to carry out everyday activities, as rated 0 or 1 on the ECOG scale (a standard medical measure of general wellbeing).
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning adequately, as confirmed by blood tests taken within 7 days before treatment starts.
• Women who are post-menopausal, or women of childbearing potential who have a negative pregnancy test within 72 hours before the first dose.
• Women of childbearing potential who are willing to use two methods of contraception (or are surgically sterile, or abstain from heterosexual activity) throughout the study and for 6 months after the last dose.
• Men who agree to use adequate contraception from the first dose until 6 months after the last dose.

Who may not be able to join:

• People whose head and neck cancer started in the nasopharynx, nasal cavity, sinuses, salivary glands, skin, or an unknown primary location.
• People who did not receive pembrolizumab combined with platinum/5-FU chemotherapy as their first treatment, or whose cancer did not progress on that treatment before enrolling (certain combinations involving other immunotherapy agents may be considered after discussion with the trial sponsor).
• People who have previously received paclitaxel or cetuximab for recurrent or metastatic disease.
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord (carcinomatous meningitis) — although people with previously treated and stable brain metastases that have not grown for at least 4 weeks, and who are not taking steroids for at least 7 days before starting the trial, may be considered (confirm with trial site).
• People with a life expectancy of less than 3 months, or whose disease is rapidly progressing (for example, with tumour bleeding or uncontrolled tumour pain), in the treating doctor's judgement.
• People with a history of another cancer, unless it was treated with curative intent and has shown no signs of activity for 3 or more years, or was a non-melanoma skin cancer or carcinoma in situ that has been fully treated with no evidence of disease.
• People who have had major surgery for their current cancer (other than a diagnostic biopsy) or any major surgery within 28 days before the study treatment starts (tracheostomy or feeding tube placement within 28 days may be allowed if the person is clinically stable).
• People who have had palliative radiotherapy that was not completed at least 2 weeks before the first dose of study treatment.
• People with a known allergy or serious reaction to any of the study drugs or their ingredients.
• People who have had an organ transplant requiring ongoing immunosuppressive medication, or who have taken immunosuppressive medicines within 28 days before starting the study, or who have previously had a severe (grade 3 or 4) immune-related reaction to another immunotherapy or a severe infusion reaction.
• People currently receiving any other chemotherapy, biological, immunological, or hormonal cancer treatment (non-cancer hormonal treatments such as insulin or hormone replacement therapy are acceptable).
• People who have taken immunosuppressive medication within 7 days before starting the study, with certain exceptions such as low-dose steroids, inhaled or topical steroids, and steroids used to prevent allergic reactions (confirm specifics with trial site).
• People with unresolved immune-related side effects from previous treatment rated above grade 2 (moderate) that are not well controlled, as judged by the treating doctor.
• People with a history of a primary immune deficiency disorder; people who are HIV-positive, unless they are on stable HIV treatment with an undetectable viral load and adequate immune cell counts at the screening visit.
• People who have had a stroke or mini-stroke (TIA) within the past 6 months.
• People with certain heart conditions, including unstable angina, moderate-to-severe heart failure, certain abnormal heart rhythms, a significantly reduced heart pumping function, or a prolonged QTc interval on an ECG (confirm thresholds with trial site).
• People with pre-existing nerve damage (neuropathy) rated grade 2 or above.
• People with a history of interstitial lung disease, non-infectious lung inflammation, severe chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or other uncontrolled lung conditions (specific cases may be discussed with the sponsor).
• People with active hepatitis B or active hepatitis C infection (people who have completed treatment for hepatitis C with no detectable virus, or those on antiviral treatment for hepatitis B with no detectable virus and preserved liver function, may be considered after discussion with the sponsor).
• Women who are pregnant or breastfeeding.
• People with an uncontrolled serious infection requiring intravenous antibiotics within 2 weeks before treatment starts.
• People with uncontrolled psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
• People with any other condition that, in the treating doctor's opinion, would interfere with the study or the safety of the participant.

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