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 diagnosed with melanoma that cannot be surgically removed or has spread to other parts of the body, including cases where the original source of the melanoma is unknown, or where it started in the mucous membranes. Diagnosis must have been confirmed through a previous biopsy or lab test.
• People diagnosed with head and neck squamous cell carcinoma (a type of cancer affecting the head and neck area) that has come back or spread, and whose cancer continued to grow during or after treatment with platinum-based chemotherapy.
• People who have previously received certain immunotherapy drugs (anti-PD-1 or anti-PD-L1 treatments) may still be considered, as long as it has been at least 6 months since the last dose, all other criteria are met, and imaging has confirmed the cancer has progressed (meaning new spread has appeared, or existing tumours have grown by 5% or more).
• People with melanoma who have never received prior treatment for their cancer may also be considered.
• Adults aged 18 or older.
• People with a general health and activity level that falls within a certain range, as measured by a standard medical scoring system called ECOG performance status 0–2 (confirm with trial site for what this means in practice).
• Women who could become pregnant must have a negative pregnancy test taken within 72 hours before starting treatment. Both women who could become pregnant and male participants must agree to take appropriate steps to prevent pregnancy during the trial.
• People with no active (ongoing) bleeding.
• People whose life expectancy is estimated to be greater than 12 weeks.
• People who are willing and able to sign the trial consent form.

Who may not be able to join:

• People who have previously received a type of drug called a galectin antagonist.
• People with an active autoimmune disease (a condition where the immune system attacks the body), except for autoimmune thyroid conditions or vitiligo (a skin condition causing loss of pigment).
• People with a history of autoimmune colitis (immune-related inflammation of the large bowel).
• People who have untreated cancer spread to the brain. People whose brain metastases have been treated and shown to be stable on follow-up scans taken 4 or more weeks after treatment may still be considered.
• People who are currently receiving other cancer treatments, including other experimental therapies.
• People who have received any anti-cancer treatment within 3 weeks, or within 5 half-lives of that treatment, before the first dose of the study drug (confirm with trial site).
• People with severe liver impairment classified as Child-Pugh C (confirm with trial site).
• People with an active infection currently being treated with antibiotics.
• Women who are pregnant or breastfeeding, due to unknown risks to the baby.
• People who require ongoing steroid medication at doses higher than what the body would naturally produce, except for inhaled steroids, which are acceptable.
• People whose recent blood test results (taken within 28 days of enrolling) fall outside acceptable ranges, including:
  • White blood cell count below a certain level
  • Haemoglobin (a measure of red blood cells) below a certain level
  • Liver enzyme levels above a certain threshold
  • Bilirubin (a liver-related substance) above a certain level, unless the person has a condition called Gilbert's Syndrome, in which case a different measurement is used
  • A known history of, or active, HIV
  • A known history of, or active, Hepatitis B
  • A known history of, or active, Hepatitis C
  • Platelet count (cells that help blood clot) below a certain level without recent transfusion
  • A blood clotting measurement (INR) above a certain threshold
• People who are not able to give informed consent or follow the trial procedures.
• People with any other medical condition that the lead trial doctor believes could affect safety or the proper running of the trial.
• People with ongoing immune-related side effects from previous treatment — such as lung inflammation, diarrhoea, liver enzyme elevations, or other toxicities — that currently require higher-than-normal doses of steroids to manage.

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