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 who have been diagnosed with nasopharyngeal carcinoma (a type of cancer in the back of the nose and throat) that has come back in the same area or spread to other parts of the body, or who were first diagnosed when the cancer had already spread.
• People whose cancer has tested positive for a marker called EBER (a sign linked to the Epstein-Barr virus), or who have had a detectable level of Epstein-Barr virus DNA in their blood at any point since their diagnosis.
• People who have measurable cancer on imaging scans, using specific scanning standards (confirm with trial site for exact scan requirements).
• People whose cancer has spread to the brain or the lining of the brain, as long as any prior treatment for this was given and the person has been clinically stable for at least 2 months before joining, and steroid medications have been stopped for more than 4 weeks beforehand.
• People whose cancer involves the base of the skull, as long as the cancer is not directly growing into the brain tissue or causing certain brain-related symptoms or swelling (confirm with trial site).
• People aged 18 years or older.
• People who are reasonably well and able to carry out daily activities, as measured by a standard health performance scale (ECOG score of 0, 1, or 2).
• People who can become pregnant must have a negative pregnancy test within 14 days before joining.
• People whose blood counts and organ function meet specific levels before joining, including:
  • A white blood cell (infection-fighting cell) count at or above a minimum level.
  • A platelet count at or above a minimum level.
  • A haemoglobin (red blood cell) level at or above a minimum level (blood transfusions are allowed to help meet this, but not certain injected medications that stimulate red blood cell production).
  • Liver function tests within acceptable ranges.
  • Kidney function within acceptable ranges.
  • Calcium levels within acceptable ranges (treatment for high calcium before starting is allowed).
• People who have not previously received chemotherapy or other systemic (whole-body) treatments aimed at controlling or palliating their returned or spread cancer.
• People whose prior treatment for their original (non-returned, non-spread) cancer ended more than 6 months before their cancer came back.
• People whose side effects from any previous cancer treatments have largely resolved to mild or no symptoms before joining (with some specific exceptions, confirm with trial site).
• People with no major surgery within 30 days before joining.
• People who have not had palliative radiotherapy within 30 days before joining, unless the treated areas are not the main measurable sites of cancer being assessed.
• People with heart function rated at a mild level of limitation or better on a standard heart health scale (NYHA class I or II).
• People without active serious infections requiring intravenous (IV) antibiotic, antiviral, or antifungal treatment at the time of joining.
• People who have not received a live vaccine within 30 days before joining (most standard flu shots by injection are allowed, as are approved COVID-19 vaccines).

Who may not be able to join:

• People whose locoregional (local area) cancer could potentially be cured by surgery or repeat radiation treatment.
• People who have previously received systemic (whole-body) palliative treatment for returned or spread nasopharyngeal carcinoma, including chemotherapy.
• People who have previously received certain immunotherapy medicines that work on the immune checkpoint pathway (such as PD-1, PD-L1, LAG-3, or CTLA-4 inhibitors), unless these were given as part of early-stage treatment before the cancer returned.
• People with a history of unstable chest pain (angina) requiring hospitalisation within the last 6 months.
• People who have had a heart attack within the last 6 months.
• People with a prior history of inflammation of the heart muscle (myocarditis).
• People with a history of certain lung inflammation conditions, including conditions requiring steroid treatment, pulmonary fibrosis, or similar disorders.
• People with a history of drug-resistant tuberculosis, or active tuberculosis treated within the last 2 years.
• People who have had a solid organ transplant or bone marrow transplant.
• People currently taking high-dose steroid medications or other immune-suppressing medicines (above certain thresholds) within 14 days of joining, with some specific exceptions allowed (confirm with trial site).
• People with an active autoimmune disease (where the immune system attacks the body) that has required systemic treatment within the past 2 years. This includes conditions such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and others. Note: some milder conditions such as vitiligo, type 1 diabetes, or thyroid conditions managed with hormone replacement alone may still be eligible (confirm with trial site).
• People with a known history of a severe allergic or hypersensitivity reaction (grade 3–4) to the chemotherapy medicines used in this trial (cisplatin, carboplatin, or gemcitabine).
• People with a known history of the most severe level of allergic reaction (grade 4) to any monoclonal antibody medicine.
• People whose cancer is directly growing into the brain tissue with symptoms and/or significant brain swelling on scans.
• People who received a live attenuated (weakened virus) vaccine, such as those for measles, mumps, chickenpox, or nasal spray flu vaccine, within 30 days before joining.

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