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:

• You have been diagnosed with a specific type of throat or voice box cancer (squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma) located in the oropharynx, larynx, or hypopharynx, confirmed by a biopsy, with no sign that the cancer has spread to distant parts of the body.
• Your cancer is classified as Stage III, IVa, or IVb, based on imaging scans and a full head and neck examination.
• If you have oropharyngeal (throat) cancer, your doctors must know the result of a specific protein test called p16 before you can be enrolled.
• You have not yet had surgery intended to cure your current Stage III, IVa, or IVb cancer (a diagnostic biopsy is allowed).
• If you had a simple tonsil removal for diagnosis, there must still be measurable cancer remaining in your body.
• If you had a previous head and neck cancer of the same type, more than 2 years must have passed since that diagnosis, it must have been treated with surgery only (no chemotherapy or radiation), and it must not have come back.
• You have not previously received chemotherapy, targeted therapy, or radiation treatment for head and neck cancer.
• If you received chemotherapy or radiation for a different type of cancer in the past, at least 2 years must have passed since that treatment.
• You have not had radiation treatment to the neck or head area (above the collarbone) before.
• If you had a different type of cancer in the past that was treated with the intention to cure, you must have been cancer-free for at least 2 years (with some exceptions — confirm with trial site).
• A sample of your tumor tissue must be available for specific laboratory testing.
• You are able to carry out normal daily activities with little or no restriction (confirm with trial site for the exact fitness level required).
• You are 18 years of age or older.
• Your cancer can be measured using standard imaging criteria.
• Your recent blood test results (taken within 14 days of signing up) must show that your blood counts, kidney function, liver function, and levels of certain minerals (such as calcium, magnesium, potassium, and sodium) are within acceptable ranges.
• You have never had a severe allergic reaction to a type of drug called a monoclonal antibody.
• You are willing and able to give written informed consent to take part in the study.
• Women who could become pregnant must have a negative pregnancy test within 14 days of registration.
• You and your partner must agree to use effective contraception throughout the study if there is any chance of pregnancy.

Who may not be able to join:

• Your cancer has spread to distant parts of the body.
• You have two separate head and neck cancers at the same time, unless both are tonsil cancers or you have had a small, successfully removed thyroid cancer of a specific type (confirm with trial site).
• You have already received chemotherapy, targeted therapy, or radiation for head and neck cancer.
• You have previously had a severe allergic reaction to a monoclonal antibody drug.
• You have had a heart attack or unstable chest pain in the past 6 months, have serious heart failure, have a serious heart rhythm problem requiring medication, or have had a stroke or mini-stroke in the past 6 months.
• You have an uncontrolled ongoing illness, such as an active infection, uncontrolled diabetes, uncontrolled high blood pressure, or an uncontrolled mental health condition that could affect your ability to take part safely.
• You are pregnant or breastfeeding, as the study drugs may be harmful to an unborn baby or nursing infant.
• You are HIV-positive and currently taking combination anti-HIV medication, due to possible interactions with the study drugs.
• You are currently taking part in another clinical trial involving cancer treatment drugs.
• Your blood mineral levels (calcium, magnesium, potassium, or sodium) remain outside safe limits even after attempts to correct them.

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