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 diagnosed with advanced (stage III to IVB) poorly differentiated head and neck cancer — specifically cancer of the hypopharynx, larynx, oropharynx, or nasal cavity and sinuses (nasopharyngeal cancer is not included) — confirmed by a tissue or cell sample
• People who are able to receive systemic (whole-body) treatment or a type of immunotherapy called a PD-1/L1 inhibitor before starting the trial
• People joining a specific group within the trial (Arm 2) must have tumours that doctors have assessed as able to be surgically removed
• People whose treating doctor considers it safe for them to receive a combination of immunotherapy (PD-1 inhibitor), platinum-based chemotherapy, and a type of chemotherapy called albumin-bound paclitaxel
• People aged 18 or older
• People with a general health and activity level rated as 0 or 1 on a standard scale used by oncologists (meaning fully active or able to carry out light work)
• People with at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People with blood counts and organ function within acceptable ranges, including: enough white blood cells, platelets, and haemoglobin, without having needed a recent blood transfusion or red blood cell-stimulating medication in the past 7 days
• People with kidney function within acceptable limits, based on blood or urine tests (confirm with trial site)
• People with liver function within acceptable limits, based on blood tests measuring liver enzymes and proteins (confirm with trial site)
• People with blood clotting function within acceptable limits, or if on blood-thinning medication, clotting results within the range allowed for that medication
• Women who agree to use effective contraception (such as an IUD, contraceptive pill, or condom) during the trial and for 6 months after it ends, who are not breastfeeding, and who have a negative pregnancy test within 7 days before joining
• Men who agree to use effective contraception during the trial and for 6 months after it ends

Who may not be able to join:

• People who have previously received a PD-1/L1 inhibitor combined with chemotherapy
• People who have had another type of cancer in the past 5 years — except for early-stage (stage 1 or 2) skin cancer or non-invasive cancer that was treated with the aim of a cure
• People who would not be able to tolerate radiotherapy after surgery
• People known to have an allergy to any of the study drugs or their ingredients
• People with unstable or serious ongoing health conditions, including severe infection, uncontrolled diabetes, unstable chest pain (angina), recent stroke or mini-stroke, recent heart attack, heart failure, immune deficiency, chronic infections such as HIV, hepatitis, or tuberculosis, or autoimmune diseases
• People with blood-related problems including bleeding disorders, a history of serious gastrointestinal bleeding requiring medical intervention in the past 6 months, or active blood clots (in the lungs or deep veins) that are not stable on blood-thinning treatment
• People with a history of, or current evidence of, active non-infectious lung inflammation (pneumonitis)
• People with active cancer spread to the brain or the lining of the brain and spinal cord — although people with previously treated and stable brain metastases may be considered, provided there has been no worsening on scans for at least 4 weeks, no new or growing brain tumours, and no steroid use for at least 7 days before the trial starts (confirm with trial site)
• People who are taking medications within 7 days before starting the trial that may affect how the study drugs are processed in the body (confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period
• People with any uncontrolled ongoing illness, including persistent infection, heart failure with symptoms, unstable angina, or irregular heart rhythm
• People whose heart electrical activity test (ECG) shows a QTc interval greater than 475 milliseconds during screening
• People whose heart pumping function (ejection fraction) is below 40% on an ultrasound of the heart during screening
• People with serious medical or mental health conditions, including substance use disorders, that in the treating doctor's judgement may interfere with taking part in the trial safely or following its requirements
• People who have needed systemic (whole-body) treatment for an active autoimmune disease in the past 2 years — noting that hormone replacement or similar therapies for conditions such as thyroid or adrenal insufficiency are not considered systemic treatment in this context

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