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 (confirmed by a lab test on a tissue or cell sample) with squamous cell carcinoma of the head and neck, specifically starting in the sinuses, nasal cavity, mouth, throat, voice box, or nearby areas — other locations may be considered at the doctor's discretion
• People whose cancer is at an advanced stage (Stage IV or has spread to other parts of the body) and cannot be treated with the goal of a cure through surgery or radiation
• People whose cancer got worse after receiving a first treatment that included an immune checkpoint therapy (anti-PD-1 or anti-PD-L1 drug), either alone, combined with chemotherapy, or as part of another clinical trial
• People with throat cancer (oropharynx) whose HPV status has been previously tested, or for whom testing is currently underway — enrollment may begin while testing is in progress
• People who have measurable areas of cancer that can be tracked on scans, including in areas that were previously treated with radiation if those areas show signs of cancer growth
• People aged 18 or older at the time of consent
• People who are generally well enough to carry out daily activities with little or no limitation (a level doctors call ECOG 0 or 1)
• People whose blood cell counts are within an acceptable range, tested within 30 days before joining the trial
• People whose kidneys are functioning at an acceptable level, based on blood tests done within 30 days before joining
• People whose liver is functioning at an acceptable level, based on blood tests done within 30 days before joining
• People whose blood clotting measures are within an acceptable range (or are within a safe range if already taking blood thinners)
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use highly effective contraception from the time of signing the consent form until six months after the last dose of study treatment
• Women who are able to become pregnant must have a negative pregnancy blood test within 72 hours before the first dose of study treatment
• Men who agree to use contraception and to avoid donating sperm or eggs from the time of signing the consent form until five months after the last dose of study treatment
• People who are willing and able to give voluntary informed consent before entering the trial

Who may not be able to join:

• People who have already received more than two prior lines of treatment for cancer that has come back or spread — cases that are unclear will be reviewed by the treating doctor
• People who have previously had a serious allergic or infusion reaction to EGFR antibody treatments (a type of targeted cancer therapy) that the doctor considers too risky to use again
• People who have previously been treated with a type of chemotherapy called a topoisomerase I inhibitor for head and neck cancer
• People with a confirmed or suspected diagnosis of Gilbert's Syndrome, a liver condition (confirm with trial site regarding borderline cases)
• People who have received any anti-cancer treatment — including chemotherapy, targeted therapy, biological therapy, or radiation — within two weeks before the start of the trial
• People who have not yet recovered from significant side effects of a previous cancer treatment — though people with mild ongoing nerve problems or hair loss (Grade 2 or below) may still be considered, as may those with certain mild ongoing immune-related side effects that are stable
• People who have another active, separate cancer at the same time, unless approved by the doctor
• People who have had a prior cancer (other than certain common skin cancers) unless they have been cancer-free for at least three years, or their previous cancer had a very high cure rate — subject to the doctor's review
• People with serious, active health conditions such as unstable chest pain or heart failure needing hospital care in the last six months, a heart attack in the last six months, a serious active infection requiring intravenous antibiotics, a recent severe lung condition, or liver failure causing yellowing of the skin or blood clotting problems
• People with active cancer that has spread to the brain or the lining of the brain — though people with previously treated brain metastases that have been stable for at least four weeks and who meet specific other conditions may be considered
• People with active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), immune-related bowel inflammation, or a bowel perforation within six months of starting the trial
• People with HIV that is untreated or poorly controlled — other immune system conditions will be reviewed on a case-by-case basis
• People with an active hepatitis B or hepatitis C infection (people who have had hepatitis C but show no active virus in their blood may still be considered)
• People who have used herbal remedies that could interfere with major organ function within 28 days before the first dose, unless agreed upon by the treating doctors
• Women who are pregnant, breastfeeding, or plan to become pregnant during the study

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