Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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 are able to give their full informed consent and understand what taking part in the trial involves
• Adults aged 18 or older (or older if local laws require a higher age of consent)
• People who have solid tumour cancers that have spread, cannot be surgically removed, or are locally advanced and can be injected directly through the skin
• People with any type of solid tumour (in the early phases of the trial), with a particular focus on skin squamous cell cancers and head and neck cancers in the later phase
• People who have at least one tumour that can be measured and is suitable for direct injection through the skin, under the skin, or in a lymph node
• People who have at least one tumour measuring more than 1 cm across, as confirmed by ultrasound or physical measurement
• People for whom all standard approved treatment options have been tried, are unavailable, are unlikely to help significantly, or who have chosen not to pursue them
• People who are generally well enough to carry out light activity and care for themselves (confirm with trial site regarding the specific fitness scale used)
• People with a life expectancy of more than 6 months
• People whose cancer has been confirmed by laboratory or tissue testing as locally advanced or metastatic
• People whose blood test results meet specific minimum levels for immune cells, platelets, haemoglobin, liver function, and kidney function (the trial site will check these)
• People who are willing and able to attend scheduled visits, follow the treatment plan, and undergo required scans and blood tests

Who may not be able to join:

• People who have active cancer that has spread to the brain or spinal cord lining, or who need radiation or surgery to the brain, or who have been on increasing steroid doses in the past 2 weeks for brain metastases (people with treated and stable brain metastases who have been off steroids for at least 2 weeks may still be considered)
• People whose tumours are located near a major blood vessel where tumour breakdown could be dangerous
• People with serious or uncontrolled heart problems, including heart failure requiring treatment, reduced heart pumping function, uncontrolled high blood pressure, significant irregular heartbeat, a heart attack, or unstable chest pain within the past 6 months
• People with current or past lung inflammation caused by a drug (interstitial pneumonitis or pneumonia)
• People with HIV infection, or hepatitis B or C
• People with ongoing significant liver disease or chronic hepatitis with moderate to severe liver impairment
• People with another active cancer, except those that were fully treated and have not returned within the past 2 years, certain fully removed skin cancers, slow-growing cancers that have never needed treatment, or fully removed pre-cancerous conditions
• People currently taking long-term steroid tablets or other immune-suppressing medicines above a certain dose (low-dose steroids used on the skin, inhaled, or as nasal or eye drops are generally allowed)
• People who have received a live vaccine against an infectious disease within 4 weeks of starting the trial
• People who have had a stroke or who currently have active neurological symptoms (some stable, longstanding conditions may be considered — confirm with trial site)
• People who currently have an active infection requiring antibiotic or antiviral treatment
• People with an active cytomegalovirus (a type of viral) infection
• People who have had major surgery within 2 weeks before the first dose of the trial treatment
• People who have not yet recovered from side effects of previous cancer treatments, or who received certain cancer drug treatments too recently before the trial start date
• People who have previously been treated with a type of cancer therapy called oncolytic virotherapy
• People who still have significant ongoing side effects (grade 2 or higher on a standard medical scale) from previous cancer treatment, with some specific exceptions
• People who have taken part in another clinical trial within 4 weeks (or within a shorter timeframe depending on the previous trial drug) before starting this trial
• People with any other medical condition that the trial doctor believes would make participation unsafe or impractical
• People who are pregnant or breastfeeding; women who could become pregnant must agree to use highly effective contraception during the trial and for 6 months after the last dose of the trial drug Ixovex-1, and for 4 months after the last dose of pembrolizumab (if applicable); men must use a condom or be surgically sterile during the trial and for the same timeframes
• People with a known allergy to any ingredient in Ixovex-1, or to pembrolizumab (relevant in later phases of the trial)

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