Phase 3 Head and Neck Cancer Trial, Terminated

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 are able to give their agreement to take part after being fully informed about the trial.
• People diagnosed with head and neck squamous cell cancer (a specific type of cancer affecting the mouth, throat, voice box, or part of the throat called the hypopharynx) that has come back or spread, and cannot be cured with local treatments such as surgery or radiation.
• People who have not received systemic (whole-body) cancer treatment for their returned or spread cancer — with an exception for those who completed such treatment more than 6 months ago as part of an earlier curative plan, provided the cancer did not return within 6 months of finishing that treatment.
• People whose cancer can be measured on scans according to a standard set of measurement rules (RECIST v1.1).
• People who are generally well enough to carry out light daily activities, as rated on a standard medical scale (a score of 0 or 1 on the ECOG scale — meaning fully active or able to do light work).
• People whose organs (such as kidneys, liver, and bone marrow) are functioning at an adequate level as determined by blood tests.
• People with a life expectancy of at least 12 weeks, as assessed by their doctor.
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use a highly effective form of contraception starting 30 days before joining the trial and for at least 120 days after the last dose of study treatment.
• Men with female partners who could become pregnant must agree to use highly effective contraception during treatment and for at least 120 days after the last dose, and must not donate sperm during this time.
• People who can provide a tumour tissue sample from a surgical removal or core biopsy (not a fine needle sample or bone biopsy) taken within the past 2 years, for specialised laboratory testing of a protein called PD-L1.
• People whose PD-L1 test result is available from the trial's central laboratory.
• People with cancer in the oropharynx (part of the throat) who have had testing for HPV (human papillomavirus) status.

Who may not be able to join:

• People who have previously received certain types of immunotherapy treatments that target the PD-1, PD-L1, PD-L2, or ICOS pathways.
• People who have received approved or experimental cancer treatments within the past 30 days (or within 5 half-lives of the drug, whichever is shorter), or where fewer than 14 days have passed since the last dose.
• People considered to be at high risk of serious bleeding — for example, if the tumour is wrapped around or growing into a major blood vessel (such as the carotid artery or jugular vein), or if there are other high-risk features such as an abnormal connection between arteries and veins.
• People who have active bleeding from their tumour.
• People with severely high calcium levels in the blood (Grade 3 or 4 hypercalcaemia).
• People who have had major surgery within 28 days before joining, or who have not fully recovered from any surgery (major or minor) and its complications.
• People who experienced serious side effects (Grade 3 or 4) from previous immunotherapy that led to stopping that treatment, or who still have unresolved side effects from prior cancer treatment above a mild level (with some exceptions such as hair loss, hearing loss, certain hormone conditions managed with medication, and nerve-related symptoms at a moderate level or below).
• People who have received a blood transfusion or certain blood-boosting injections (colony stimulating factors) within the 14 days before joining.
• People with cancer that has spread to the brain or spinal cord — unless those brain metastases cause no symptoms, are considered stable, and have not required steroid medication for at least 14 days before joining.
• People who have had another invasive cancer within the past 3 years — with exceptions for certain cancers that were fully treated and have been in remission, non-melanoma skin cancers that were cured, successfully treated early-stage cancers confined to one area, or certain low-risk prostate cancers that have been stable.
• People with an autoimmune disease or related condition that required whole-body (systemic) medical treatment within the past 2 years.
• People with a known immune deficiency condition, or who are taking steroid medications above a low dose (more than 10 mg of prednisone or equivalent) or other immune-suppressing medications within 7 days before joining.
• People who have received a live vaccine within 30 days before joining.
• People who have previously had a bone marrow transplant or a solid organ transplant (from another person or their own stored cells).
• People who currently have, or have a history of, non-infectious lung inflammation (pneumonitis) that required steroids or immune-suppressing treatment.
• People who have had uncontrolled fluid build-up in the abdomen, around the lungs, or around the heart within the past 6 months.
• People who have had a bowel blockage requiring surgery, inflamed pouches in the gut (diverticulitis), inflammatory bowel disease, or an abdominal abscess within the past 6 months.
• People who have undergone allergy desensitisation treatment within 4 weeks before joining.
• People with certain heart conditions diagnosed within the past 6 months, including serious irregular heartbeat, significant heart rhythm abnormalities, heart muscle disease, heart attack, unstable chest pain, heart procedures such as stenting or bypass surgery, certain levels of heart failure, or inflamed tissue around the heart.
• People with unstable liver or bile duct disease, as assessed by their doctor, based on signs such as fluid in the abdomen, brain function problems, abnormal clotting, low protein levels, swollen veins in the oesophagus or stomach, persistent yellowing of the skin or eyes, or cirrhosis.
• People with an active infection that requires treatment with medication throughout the body.
• People known to have HIV, active hepatitis B, or active hepatitis C infection.
• People with a history of severe allergic reactions to monoclonal antibody treatments or to the chemotherapy drugs being studied in this trial.
• People with a known history of active tuberculosis.
• People with any serious (Grade 3 or higher) or unstable pre-existing medical condition, other than the cancer being studied.
• People with a psychiatric condition or any other condition that, in the opinion of the trial doctor, could affect safety, the ability to give informed consent, or the ability to follow the trial procedures.
• People currently taking part in, or who have taken part in, another clinical trial involving an experimental treatment or device within 4 weeks before joining.

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