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 confirmed by a pathology test to have locally advanced (but not spread to distant parts of the body) squamous cell carcinoma (a type of cancer) in one of these areas: the mouth, throat (including the oropharynx, hypopharynx, or nasopharynx), voice box, or sinuses.
• People whose throat cancer (oropharyngeal type) has been tested and confirmed to be unrelated to HPV (human papillomavirus), based on a specific laboratory staining test showing a negative result.
• People whose cancer started in the nasopharynx (upper throat) and has been confirmed by lab testing to be unrelated to both HPV and EBV (Epstein-Barr virus).
• People who are able to understand and agree in writing to the trial's requirements and are willing to follow the study schedule, including all visits, treatments, and check-ups.
• People whose cancer is classified as Stage IV (or, for nasopharyngeal cancers, at least Stage III with a specific tumour and lymph node classification — confirm with trial site) based on international staging guidelines.
• People who have at least one tumour that can be accurately measured using standard imaging or examination tools, meeting specific size requirements (confirm with trial site).
• People who have not previously received radiation therapy, chemotherapy, or immunotherapy for a head and neck cancer.
• People aged 18 years or older.
• People whose physical functioning is rated at a level where they are either fully active or have only minor limitations in physically demanding activity (confirm with trial site).
• People whose blood tests show that the heart, liver, kidneys, and bone marrow are functioning well enough to meet specific levels set by the trial (confirm with trial site for exact values).
• People who have had another cancer in the past or present, where that cancer and its treatment are not expected to interfere with this trial's safety or results.
• People with a known history of heart disease or who have previously been treated with medications that can affect the heart, and whose heart function is rated at a level considered suitable for the trial (confirm with trial site).
• People who have not had complete surgical removal of a head and neck cancer within the 8 weeks before joining the trial, though minor procedures such as a lymph node biopsy or partial removal with remaining measurable disease may still be acceptable (confirm with trial site).
• People who are willing to use effective contraception throughout the trial and for a period after the trial ends, as required by the protocol (confirm with trial site for specific requirements based on individual circumstances).

Who may not be able to join:

• People whose cancer has clearly spread to distant parts of the body (metastatic disease).
• People where the original location of the cancer cannot be identified.
• People who have already had major surgery to remove the cancer, beyond minor biopsy procedures or emergency airway procedures. Some measurable tumour must remain.
• People who are currently participating in another clinical trial involving an investigational treatment.
• People who have another currently active cancer, other than certain non-melanoma skin cancers. People who have completed treatment for another cancer and have been free of that disease for 3 or more years, or who have had certain low-risk cancers, may still be considered (confirm with trial site).
• People who have had a significant allergic reaction to medicines that are chemically or biologically similar to the treatments used in this trial.
• People who have an uncontrolled ongoing illness.
• People who are pregnant or breastfeeding.
• People of childbearing potential or those who could father a child who are not willing to use effective contraception from the start of the trial through to at least 90 days after the last dose of the study drug (confirm with trial site for specific contraception requirements).
• People whose other ongoing health conditions would make it too difficult to tolerate the treatment or would be likely to affect their survival, including serious active infections, immune system disorders, significant breathing problems, or serious mental health or social circumstances that would make it hard to follow the study requirements.
• People with any of the following heart conditions:
  • Any type of weakened heart muscle (cardiomyopathy) or history of heart muscle inflammation (myocarditis)
  • Heart failure classified as severe (New York Heart Association class III or IV)
  • Uncontrolled high blood pressure
  • Unstable chest pain (angina)
  • Clinically significant narrowing of the heart's arteries, neck arteries, or leg arteries
  • A heart attack or heart procedure (such as stenting or bypass surgery) within the past 12 months
  • A procedure on an artery in the legs or other body part within the past 12 months
  • Serious heart rhythm problems requiring treatment, certain types of heart block, or abnormal heart node function not managed with a pacemaker (people with stable and well-controlled atrial fibrillation may still be considered — confirm with trial site)
  • A history of having to stop a previous medication because it caused dangerous changes in heart rhythm
  • A genetic or family history of abnormal heart rhythm (long QT syndrome), or unexplained sudden death in a close family member under 40 years of age
  • A planned heart surgery or coronary procedure
  • A planned artery-clearing procedure within 6 months of joining the trial
• People with any of the following active infections:
  • Active tuberculosis (TB)
  • HIV infection that is not well controlled (people with well-controlled HIV meeting specific criteria may still be considered — confirm with trial site)
  • Active or uncontrolled hepatitis B or C (people with certain controlled or resolved forms of these infections may still be considered — confirm with trial site)
  • Active hepatitis A
• People diagnosed with an immune deficiency condition, or who are taking steroid medications at doses higher than a low maintenance level, or any other medicines that suppress the immune system, within 14 days before the first dose. (Low-dose, local, or inhaled steroids, and certain other exceptions, may be acceptable — confirm with trial site.)
• People with an active or previously documented autoimmune or inflammatory condition such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar disorders. Some conditions may be exceptions, such as stable thyroid conditions managed with hormone replacement, vitiligo, hair loss conditions, certain controlled skin conditions, or celiac disease managed by diet alone (confirm with trial site).
• People who have received an organ transplant from another person.
• People with a known history of, or any current signs of, non-infectious lung inflammation (pneumonitis).
• People who have received a live vaccine within 30 days before starting the trial.
• People who donate blood are not able to donate during the trial and for 3 months after their last dose of the study drug.

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