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 laboratory testing of tissue or cell samples) with salivary gland cancer that has come back or spread, and whose cancer tests positive for a protein called HER2 (either at a high level called "HER2-positive" or a lower level called "HER2-low")
• People whose cancer cannot be removed by surgery, or where surgery or radiation aimed at curing the disease is not an option, or whose cancer has clearly returned or spread as shown on scans
• People who have had treatment for cancer that spread to the brain, as long as follow-up scans show the brain cancer is not getting worse — and people with new or active brain involvement may also be considered if the treating doctor feels immediate brain-specific treatment is not urgently needed (confirm with trial site)
• People aged 18 or older
• People whose heart is pumping well enough, specifically with the heart's pumping function (left ventricular ejection fraction) measured at 50% or above on a heart scan done within 30 days before joining
• People who are reasonably well and able to carry out daily activities, based on a standard medical rating scale scored 0 to 2 (confirm with trial site)
• People whose blood test results within 14 days before joining show healthy enough levels of white blood cells, platelets, and red blood cells
• People whose kidney function tests are within an acceptable range within 14 days before joining
• People whose liver function tests are within an acceptable range within 14 days before joining (specific limits differ slightly between the HER2-positive and HER2-low groups — confirm with trial site)
• People in the HER2-low group whose blood protein (albumin) level is 2.5 g/dL or above within 14 days before joining
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
• People with a history of hepatitis B who are on suppressive treatment and have an undetectable viral load
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load
• People who are not able to become pregnant, or people who can potentially become pregnant and have had a negative pregnancy test within 14 days before joining
• People who are willing to use highly effective contraception during the study and for 7 months after the last dose of the study treatment — this applies to both people who could become pregnant and people who could make a partner pregnant; sperm and egg donation must also be avoided during this period
• People who have already received chemotherapy or palliative radiation and have recovered from most side effects (down to a mild level or lower) before joining
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial
• People who are able and willing to give their informed consent to take part, and in the United States, to allow release of their personal health information

Who may not be able to join:

• People in the HER2-positive group who have already received systemic (whole-body) treatment specifically for their salivary gland cancer after it became unresectable, recurrent, or metastatic — though prior chemotherapy for a different cancer, prior hormone-targeting therapy, or prior HER2-directed treatment given before or after surgery or alongside radiation is allowed (confirm with trial site)
• People in the HER2-low group who have already received HER2-targeted treatment for unresectable, recurrent, or metastatic disease
• People with serious active health conditions, including: unstable chest pain (angina) requiring hospitalisation in the last 6 months; a heart attack within the last 6 months; significant heart failure (rated class III or IV on a standard medical scale); persistent severe abnormalities in blood electrolyte levels that cannot be corrected; or an active serious infection currently requiring intravenous antibiotics, antivirals, or antifungal medicines
• People in the HER2-positive group who have significant nerve damage in their hands or feet (grade 3 or higher peripheral neuropathy)
• People with certain lung conditions, including scarring of the lung tissue, inflammation of the lung, or signs of active lung inflammation shown on a chest scan
• People who have had a serious bleeding event (grade 3 or higher) within 28 days before joining
• People who have had a serious allergic reaction to medicines that are similar in makeup to the study drugs (specific drugs differ by group — confirm with trial site)
• People who have previously received high cumulative doses of certain chemotherapy drugs called anthracyclines (such as doxorubicin, epirubicin, or mitoxantrone) above specified limits (confirm with trial site)
• People in the HER2-low group who have received a live attenuated vaccine within 30 days before starting the study treatment (note: mRNA vaccines and certain other types are not considered live attenuated vaccines — confirm with trial site)
• People who are pregnant or who are unwilling to stop breastfeeding

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