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 aged 18 or older who have given written consent to participate
• People who have been diagnosed with a specific type of head and neck cancer called squamous cell carcinoma (confirmed by a tissue or cell sample), where the cancer has spread or come back and cannot be cured with surgery or radiation. The cancer must have started in the mouth, throat (with or without HPV involvement), voice box, or the area around the voice box
• People with throat cancer (oropharyngeal cancer) who have documented test results showing their HPV status
• People who have at least one tumor that can be measured on a scan
• People who are generally well enough to carry out light activity and care for themselves (this is measured on a standard medical scale called ECOG, at level 0 or 1)
• People whose life expectancy is greater than 12 weeks
• People joining Group A: Those whose cancer has spread or returned, who have already received two or three rounds of treatment including an immunotherapy drug and a platinum-based chemotherapy, and whose cancer continued to grow during or after that treatment
• People joining Group B: Those whose cancer has spread or returned but who have not yet received any systemic (whole-body) treatment for this stage of the disease
• People who are willing and able to have two tumor biopsies — one before treatment starts and one during treatment
• People with no current or past hepatitis B infection (with some exceptions — confirm with trial site)
• People with no active hepatitis C infection; those with an undetectable hepatitis C virus level on a blood test may still be considered
• People with no known history of HIV infection (HIV testing is only required for those with known risk factors)
• People who are willing and able to attend scheduled visits and follow the study requirements
• People who use feeding tubes (such as a gastrostomy tube) may still be considered
• People whose liver, kidneys, blood, and other organs are functioning well enough as defined by the study (confirm with trial site)
• Female participants who meet specific criteria around pregnancy and contraception as outlined in the study protocol (confirm with trial site)
• Male participants who agree to follow specific contraception requirements during the study and for at least 5 months after the last dose of the study drug

Who may not be able to join:

• People whose head and neck cancer is not the squamous cell type (for example, adenocarcinoma, salivary gland cancer, or sarcoma), or whose cancer started in the nasopharynx (upper part of the throat behind the nose) or the sinuses around the nose
• People with head and neck squamous cell cancer where the original location of the cancer is unknown, even if the cancer type is confirmed
• People who still have side effects from previous cancer treatment that have not improved to a mild level or returned to their pre-treatment state (with some exceptions such as hair loss, certain nerve problems, or conditions managed with hormone replacement)
• People who have taken part in another experimental clinical trial within the 4 weeks before screening
• People who have previously been treated with specific drugs that target a protein called B7-H3, including orlotamab, enoblituzumab, or similar agents
• People who have had an autoimmune disease (where the immune system attacks the body) that required ongoing medical treatment in the 2 years before screening; also, for Group B, people who have needed regular immune-suppressing medication in the 30 days before the first dose (with some exceptions for low-dose steroids — confirm with trial site)
• People who have had a serious blood clot (such as a deep vein thrombosis or a clot in the lungs) within the 3 months before the first dose (with some exceptions — confirm with trial site)
• People with cancer that has spread to the brain, unless it meets all of the following: it causes no symptoms, has been medically stable for at least 4 weeks, has not required steroid treatment for at least 2 weeks, and shows no signs of severe swelling around the tumor on imaging; people with cancer that has spread to the lining of the brain, brainstem, or spinal cord are also excluded
• People with a history of another primary cancer, except for cancers that have been fully treated and have been inactive for 2 or more years with very low risk of return, previously treated head and neck squamous cell cancer with no signs of disease, treated non-melanoma skin cancer, treated early-stage cervical or similar cancer with no signs of return, or definitively treated non-spreading prostate cancer
• People who have had major surgery (such as surgery on the brain, chest, or abdomen) within the 4 weeks before the first dose
• People who have had a bone marrow transplant or an organ transplant at any time in the past
• People with certain heart conditions as outlined in the study protocol (confirm with trial site)
• People with poorly controlled high blood pressure, including a history of hypertensive crisis or brain swelling caused by high blood pressure, blood pressure changes requiring medication adjustment within 2 weeks before the first dose, or repeated very high blood pressure readings during screening
• People who have had significant bleeding symptoms or a strong tendency to bleed in the month before the first dose, and who have also received blood transfusions or certain blood-boosting injections within 14 days before joining, or who have donated more than 500 mL of blood within the month before the first dose
• People who have had a serious infection within the 4 weeks before the first dose
• People with a current or past history of significant lung disease (confirm with trial site)
• People with a history of severe neurological or psychiatric conditions (such as epilepsy, dementia, or major depression), or any other serious or unstable medical or mental health condition that the trial doctor believes could affect safety or the ability to follow the study
• People with active kidney problems, including those who need dialysis or have any other significant kidney condition that could affect their safety
• People who are allergic or sensitive to any component of the study drug (GSK5764227); people with a history of severe allergic reactions such as anaphylaxis; or people with known reactions to certain types of laboratory-made proteins. For Group B, this also includes allergies to the drug dostarlimab
• People who have received a live vaccine within 30 days before the start of the study
• People with any condition that the trial doctor believes could put them at risk or affect the study results
• People with serious liver conditions, including liver failure, certain types of cirrhosis, or unstable liver or bile duct disease. Also excluded are people who test positive for certain hepatitis B markers at screening, or who have a positive hepatitis C antibody or RNA test at or near screening (with some exceptions — confirm with trial site)
• People who have received previous cancer treatment and have not waited long enough since their last dose before joining the trial, as defined by the study (generally at least 28 days or 5 half-lives of the drug, whichever is shorter)
• People who have had targeted radiation therapy to one area within 2 weeks before the first dose, or wider-area radiation therapy within 4 weeks before the first dose
• People who are currently taking, or have taken within 7 days before the first dose, certain medications that are not compatible with the study treatment (confirm with trial site for the specific list)

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