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:

• Adults aged 18 or older
• People whose tumour tissue tests show a PD-L1 combined positive score (CPS) of 1 or higher (a measure of a protein on cancer cells)
• People diagnosed with advanced head and neck squamous cell cancer (HNSCC) affecting the mouth, throat, or related areas (stage II–IV), where surgery would normally be recommended as standard care
• People whose primary tumour can be biopsied fresh, or for whom stored frozen tumour tissue is already available
• People who are reasonably active and able to carry out daily activities, as measured by a standard performance scale (ECOG score of 0 or 1)
• People whose blood test results show healthy enough levels of white blood cells, platelets, and haemoglobin (without a recent blood transfusion in the past 14 days)
• People whose liver function blood tests fall within acceptable ranges set by the trial site
• People whose kidney function is adequate, as shown by blood or urine tests
• People whose urine protein levels are within acceptable limits
• People whose blood clotting test results are within acceptable ranges (or, if already on blood-thinning medication, those who are on a stable dose)
• People who can have a pregnancy test done before joining, and who test negative (applies to those who could become pregnant)
• People who are able and willing to use highly effective contraception from the start of screening until 90 days after the last dose of the study drug (applies to those who could become pregnant or whose partner could become pregnant)
• People who are able to understand the study and are willing to sign a written consent form
• People who have been assessed and approved as suitable for the trial by both a medical oncologist and a head and neck surgeon at the University of Michigan

Who may not be able to join:

• People who have previously had radiation therapy to treat their current head and neck cancer, or who are being considered for surgery after a previous treatment attempt (salvage surgery)
• People who have previously had neck surgery on the same side as their current head and neck cancer
• People who have had major surgery or serious physical trauma in the 4 weeks before joining, or minor procedures in the 3 days before the first planned treatment dose
• People with a history of bleeding problems or blood-clotting disorders, or significant bleeding within the 4 weeks before joining
• People who have had moderate-to-severe nosebleeds within 14 days before registering for the trial
• People whose use of blood-thinning or anti-clotting medication is not stable before joining
• People who need regular steroid medication at doses higher than 10 mg of prednisone per day (or equivalent) for immune-suppressing purposes, taken within 14 days before the first dose (inhaled or skin-applied steroids are generally permitted; confirm with trial site)
• People with an active autoimmune disease that has required treatment affecting the whole body within the past 5 years (some autoimmune conditions such as vitiligo, type 1 diabetes managed with hormones only, or mild psoriasis not needing systemic treatment may still be eligible — confirm with trial site)
• People with active or symptomatic cancer spread to the brain or surrounding tissues
• People who have received a solid organ transplant or a stem cell transplant from a donor
• People with active hepatitis B (those with stable or declining levels on appropriate antiviral treatment for at least one month may still be eligible — confirm with trial site)
• People with active hepatitis C
• People with a known allergy or serious reaction to the study drug or any of its ingredients, or a history of severe reactions to similar antibody-based medicines
• People who are currently breastfeeding or plan to breastfeed during the study
• People whose scans show that major blood vessels near the tumour are narrowed or surrounded in a way that significantly raises bleeding risk, as assessed by the treating doctor
• People who have received a live vaccine within 4 weeks before joining, or who are scheduled to receive one during the study
• People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have a chronic lung condition affecting lung tissue
• People with pre-existing nerve damage in the hands or feet rated as moderate or severe (grade 2 or above on a standard scale)
• People with a history of varicose veins in the food pipe or stomach, severe ulcers, non-healing wounds, abnormal connections between internal organs, internal abdominal infections, or serious gastrointestinal bleeding within the 6 months before joining
• People who have had a flare-up of chronic obstructive pulmonary disease (a lung condition) within 4 weeks before joining
• People with a history of a hole forming in the gastrointestinal tract, bowel obstruction, or major bowel removal surgery within the 6 months before joining
• People with HIV whose virus is not under control
• People with active cardiovascular conditions, including: a history of arterial blood clots at any severity or serious venous blood clots; a heart attack, unstable chest pain, unstable blood vessel disease, mini-stroke, stroke, severe high blood pressure crisis, or coronary stent placement within the past 12 months; persistently high blood pressure above certain levels (systolic above 160 mmHg or diastolic above 100 mmHg); or moderate-to-severe heart failure, or a hospitalisation for heart failure within the past 12 months
• People with uncontrolled serious illness, including: a severe infection requiring hospitalisation within the past 4 weeks, or an active infection requiring treatment within the past 2 weeks; uncontrolled diabetes; an ongoing active infection needing antimicrobial treatment; a psychiatric illness or personal circumstances that would make it difficult to follow the study requirements; or active bleeding conditions requiring blood-thinning medication

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