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 to 65 years old
• People who have been diagnosed with head and neck squamous cell carcinoma (a type of cancer affecting the head and neck region) confirmed by laboratory testing, at a stage classified as T3 or T4, N0, and considered operable by surgery
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines
• People who have not previously received any systemic (whole-body) anti-cancer treatment for advanced or spreading disease — or, if they previously received certain chemotherapy or chemoradiotherapy treatments, at least 6 months must have passed since that treatment ended before cancer came back or got worse
• People whose general physical functioning is rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only mild limitations in physical activity
• People whose doctors estimate they are expected to live more than 3 months
• People whose blood test results show the body's organs are working well enough, including adequate levels of blood cells, liver function, kidney function, thyroid function, blood clotting, and heart enzyme levels — all within ranges specified by the trial (confirm exact values with trial site)
• Women of childbearing age whose pregnancy test comes back negative within 3 days before starting the trial medication
• People who are willing and able to use highly effective contraception (with less than 1% annual failure rate) throughout treatment and for up to 120 days after the last dose of the study drug, or 180 days after the last chemotherapy dose, if there is any risk of conception

Who may not be able to join:

• People who have been diagnosed with another cancer (other than head and neck squamous cell carcinoma) in the past 5 years — with exceptions for certain fully treated skin cancers or carcinoma in situ
• People currently taking part in another interventional clinical trial, or who have received another experimental drug or used an experimental medical device within the past 4 weeks
• People who have previously been treated with certain immune checkpoint drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar medications that affect how the immune system's T cells work (such as those targeting CTLA-4, OX-40, or CD137)
• People who have received certain Chinese herbal medicines or immune-boosting treatments (such as thymosin, interferon, or interleukin) intended to treat head and neck cancer within the 2 weeks before starting the trial
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (note: hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment for this purpose)
• People who have been taking steroid medications by mouth or injection (not including nasal sprays, inhalers, or skin creams) or other immune-suppressing treatments within the 7 days before starting the trial — except for very low doses of steroids equivalent to 10mg or less of prednisone per day
• People with fluid build-up in the chest or abdomen that cannot be controlled medically (some exceptions may apply — confirm with trial site)
• People who have received a transplanted organ from another person (except cornea transplants), or a bone marrow or stem cell transplant from another person
• People who are known to be allergic to any of the study drugs, including Pembrolizumab, carboplatin, or albumin-bound paclitaxel, or their ingredients
• People who have not yet recovered from side effects of previous treatments (recovery is generally defined as being at grade 1 or back to their normal baseline — exceptions may apply for tiredness or hair loss)
• People known to have HIV infection
• People with untreated, active hepatitis B infection (some people with hepatitis B history but low or undetectable virus levels may still be eligible — confirm with trial site)
• People with active hepatitis C infection, confirmed by positive antibody test and detectable virus levels
• People who have received a live vaccine within the 30 days before starting the trial (note: injected inactivated flu vaccines are permitted; nasal spray flu vaccines are not)
• Women who are pregnant or currently breastfeeding
• People with serious or uncontrolled health conditions, including:
  • Significant heart rhythm or electrical problems on an ECG, such as certain types of heart block or irregular heartbeat
  • Unstable chest pain, heart failure, or moderate-to-severe chronic heart failure
  • A heart attack, stroke, or similar blood vessel event in the past 6 months
  • Blood pressure that is not well controlled (above 140/90 mmHg)
  • A history of lung inflammation not caused by infection that required steroid treatment within the past year, or currently active lung scarring disease
  • Active tuberculosis of the lungs
  • An active infection currently requiring treatment with systemic medications
  • Active bowel or abdominal problems such as diverticulitis, abdominal abscess, or bowel blockage
  • Serious liver disease, including cirrhosis or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
  • Significant protein detected in urine, confirmed by a 24-hour urine test showing more than 1.0g of protein
  • A mental health condition that would prevent the person from cooperating with treatment
• People with any other medical history, condition, or abnormal test result that the trial investigators consider would make participation unsafe or unsuitable

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