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 with salivary gland cancer (any type) through a tissue sample, where the cancer has come back, spread to other parts of the body, or cannot be surgically removed.
• People who are willing to provide stored tumor tissue from a previous biopsy or surgery, if the trial doctors consider it safe and possible to do so.
• People who are 18 years of age or older (there is no upper age limit).
• People who are generally able to carry out light activities and care for themselves, but may not be able to do heavy physical work (this is measured on a standard scale called the ECOG scale, scores 0–1).
• People whose blood, liver, and kidney test results fall within the ranges required by the trial, based on tests done within 14 days before joining (confirm specific values with the trial site).
• People who have scan results showing a new or worsening lesion within the past 12 months, or new or worsening symptoms related to their cancer within the past 12 months.
• People who have at least one tumor that can be measured on a CT or MRI scan, where the lesion is at least 1 cm in size, and the tumor is not located in the brain or central nervous system.
• People who have finished prior cancer treatments at least 2 weeks before joining (3 weeks for certain antibody-based treatments), and whose side effects from those treatments have mostly resolved. Any number of previous treatments for this cancer are allowed, except prior treatment with a specific type of drug called an oral VEGFR TKI or an anti-PD-1 therapy. Prior treatment is not required to join.
• People who are able to understand the trial and are willing to sign a consent form.
• Women who could become pregnant must have a negative pregnancy test within 14 days of joining, and again within 72 hours before receiving the first dose of the study drug.
• Women who could become pregnant and are sexually active with a male partner who has not been sterilised must agree to use a highly effective form of contraception from the start of screening until 120 days after the last dose of the study drug (Ivonescimab).
• Men who have not been sterilised and are sexually active with a female partner who could become pregnant must agree to use an effective form of contraception from the start of screening until 120 days after the last dose of the study drug (Ivonescimab).

Who may not be able to join:

• People with active cancer that has spread to the brain or the lining of the brain or spinal cord. People whose brain metastases were previously treated and have been stable on imaging for at least four weeks, with no new or growing brain lesions, may still be considered.
• People who are currently receiving other cancer treatments or are taking part in another clinical trial at the same time.
• People with serious uncontrolled illnesses, such as an active infection, severe heart failure, unstable chest pain, or uncontrolled irregular heartbeat.
• Women who are pregnant or breastfeeding, as the effects of the study drug on an unborn or newborn baby are not yet known.
• People who have another cancer that is currently active or requires treatment. Exceptions include certain types of skin cancer that have been treated, cervical cancer that has not spread beyond its original location, and low-risk prostate cancer being monitored without active treatment. A history of a separate cancer that has been in remission with no signs of disease for at least 2 years is generally permitted.
• People with significant ongoing autoimmune conditions (where the immune system attacks the body). People with a stable thyroid condition called Hashimoto thyroiditis who are on hormone replacement therapy are not excluded. People who have been taking steroid medications (such as prednisone) at doses above 10 mg per day for more than 4 weeks are not eligible.
• People who have had major surgery or serious physical injury within 4 weeks before starting the trial, or who are planning major surgery within 4 weeks after the first dose.
• People who have a history of significant bleeding problems or blood clotting disorders, or who have experienced serious bleeding symptoms within 4 weeks before starting the trial — including bleeding in the digestive system, coughing up blood (half a teaspoon or more), or significant nosebleeds. People who have needed blood-thinning medication within 14 days before starting the trial are also not eligible.
• People whose blood pressure remains high (top number 150 mmHg or above, or bottom number 100 mmHg or above) even after taking blood pressure medication by mouth.
• People with a history of certain serious heart or blood vessel conditions requiring hospitalisation within the past 12 months, such as unstable chest pain, heart attack, significant heart failure, or poorly controlled heart rhythm or blood supply problems.
• People with a history of serious digestive tract problems within the past 6 months, including varicose veins in the food pipe or stomach, severe ulcers, wounds that do not heal, abnormal connections between organs (fistulas), abscesses inside the abdomen, or acute digestive bleeding.
• People who have had a serious blood clot in an artery or vein, a mini-stroke or stroke, or a severe hypertensive crisis within the past 6 months.
• People who have had a sudden worsening of a chronic lung condition called COPD within the past 4 weeks.
• People who have had a hole or tear in the digestive tract, a bowel blockage, or major bowel surgery within the past 6 months.
• People whose scans show that the cancer is growing into or wrapping around major blood vessels, or that there are hollow cavities forming inside a tumour (as assessed by the trial doctors).

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