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:

• Adults aged 18 or older
• People with a confirmed diagnosis (through tissue or cell testing) of one of the following cancers that cannot be surgically removed, has come back, or has spread: soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland carcinoma (non-adenoid cystic type), where curative treatment is no longer an option
• People with salivary gland tumours where laboratory testing has shown the tumour is negative for both HER2 and AR proteins
• People with a good general health and activity level, rated 0 or 1 on a standard medical performance scale (ECOG PS)
• People who have at least one tumour that can be measured on scans, according to standard criteria (RECIST v1.1)
• People who have not previously received a type of immunotherapy called a PD-1 inhibitor
• People who have received no more than one prior course of systemic (whole-body) cancer treatment
• People whose blood, kidney, liver, and clotting test results fall within the ranges required by the trial
• Women who return a negative pregnancy test within two weeks before starting treatment, are not breastfeeding, and agree to use highly effective contraception during the trial and for six months after the last dose
• Men who agree to use highly effective contraception during the trial and for six months after the last dose
• People who are willing to participate, can provide written consent, and are able to attend trial visits and follow trial procedures

Who may not be able to join:

• People who have had radiotherapy or other local treatments such as surgery within two weeks before enrolling, or who have not yet recovered from side effects of a previous treatment
• People who have taken part in another clinical trial within four weeks before enrolling
• People with poorly controlled heart problems, including moderate-to-severe heart failure, a weakened heart on ultrasound, unstable chest pain, a heart attack within the past year, certain irregular heart rhythms requiring treatment, or an abnormal heart electrical reading (QTc interval) above specified thresholds
• People with high blood pressure that cannot be brought within the normal range using blood pressure medication, or who have a history of a severe high-blood-pressure crisis or related brain condition
• People who have difficulty absorbing oral (swallowed) medications due to conditions such as an inability to swallow, persistent nausea or vomiting, chronic diarrhoea, or bowel obstruction
• People who have had a blood clot or stroke-related event within the six months before starting treatment, such as a transient ischaemic attack, cerebral haemorrhage, brain infarction, or pulmonary embolism
• People who currently have, or have a history of, certain lung inflammation conditions (such as interstitial lung disease, pulmonary fibrosis, or drug-induced pneumonitis) that could interfere with monitoring for lung-related side effects, or who show signs of active lung inflammation or severely reduced lung function on a chest scan at screening; people with active tuberculosis
• People whose life expectancy is assessed by the investigator as less than three months, or whose disease is rapidly worsening (for example, with tumour bleeding or uncontrolled tumour pain)
• People with abnormal blood clotting results or a tendency to bleed
• People diagnosed with an immune deficiency condition within seven days before enrolling, or who are currently taking corticosteroids or other medicines that suppress the immune system
• People diagnosed with another cancer within the past five years, except for certain cured skin cancers, cervical carcinoma in situ, breast carcinoma in situ, or other cured cancers the investigator considers acceptable
• People with known active cancer spread to the brain or central nervous system
• People whose tumour is assessed by the investigator as growing into major blood vessels, or where the tumour has broken down and is bleeding
• People with an active autoimmune disease that has required systemic treatment within the two years before enrolling
• People who have had an organ or tissue transplant from another person
• People with an active infection currently requiring systemic treatment
• People with a psychiatric illness or substance use issue that would make it difficult to follow the trial requirements
• People who test positive for HIV or have a known history of HIV infection
• People with an active hepatitis B (HBV) or hepatitis C (HCV) infection
• People who have received a live vaccine within 30 days before starting the trial
• People who have other medical history or circumstances that, in the investigator's assessment, could affect their safety or the reliability of trial results (confirm with trial site)

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