Phase 3 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 aged 18 years or older.
• People who have been diagnosed with nasopharyngeal carcinoma (a type of cancer in the back of the nose and throat) confirmed by tissue or cell testing.
• People whose nasopharyngeal carcinoma has spread to the bones and is not suitable for local or curative treatment.
• People with bone spread confirmed by at least two imaging scans, or one tissue sample plus one imaging scan, not including cases where the cancer has only spread into the base of the skull locally.
• People whose cancer may or may not have spread to other organs or lymph nodes, as long as those other areas are not measurable by standard imaging guidelines (called RECIST 1.1).
• People whose bone metastases may include areas where the bone is being broken down (osteolytic lesions), even if soft tissue is involved.
• People who have not received any systemic (whole-body) treatment for advanced or metastatic disease before, and whose previous chemotherapy or radiation therapy was completed more than 6 months before joining the trial.
• People with an expected survival of at least 3 months.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard performance scale (ECOG score of 0 or 1).
• People whose blood, liver, and kidney function results fall within acceptable ranges as assessed by specific laboratory tests (confirm with trial site for exact values).
• People who are willing and able to attend all required visits, follow the treatment plan, and complete all study-related procedures.

Who may not be able to join:

• People whose cancer has spread to only a very small number of bone sites (called osteo-oligometastatic disease).
• People with a history of severe allergic reactions to monoclonal antibody treatments, including the study drug tislelizumab.
• People who have one or more measurable metastatic sites in organs or lymph nodes, as assessed by standard imaging guidelines (RECIST 1.1).
• People with spinal cord compression that has not been treated with surgery or radiation, or where previously treated spinal cord compression has not been stable for at least 2 weeks before joining.
• People with poorly controlled fluid build-up around the lungs, heart, or abdomen that needs to be drained frequently (though people with certain indwelling drainage catheters may still be considered — confirm with trial site).
• People with poorly controlled cancer-related pain whose pain medication has not yet reached a stable dose.
• People with poorly controlled high calcium levels in the blood.
• People who have had another type of cancer within the past 5 years, unless it was a low-risk cancer that was treated with curative intent (such as certain skin cancers, early cervical cancer, early prostate cancer, or ductal carcinoma in situ — confirm with trial site).
• People with a history of autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions. People with autoimmune-related underactive thyroid on a stable hormone replacement dose, or people with type 1 diabetes on a stable insulin dose, may still be considered (confirm with trial site).
• People who have received immune-stimulating drugs (such as interferon or IL-2) within 4 weeks before joining, or within 5 half-lives of the drug, whichever is shorter.
• People who have been taking moderate-to-high doses of steroid medications or other immune-suppressing drugs within 2 weeks before joining (low-dose, short-term, or locally applied steroids may be permitted — confirm with trial site).
• People who have had a bone marrow transplant from a donor, or a solid organ transplant, at any time.
• People with a history of lung scarring conditions (such as idiopathic pulmonary fibrosis or drug-induced lung inflammation), or who show signs of active pneumonia on a chest scan.
• People with active infections including tuberculosis, hepatitis B, hepatitis C, or HIV. People with past hepatitis B or hepatitis C infection that has cleared may still be considered depending on specific test results (confirm with trial site).
• People with serious underlying health conditions that the trial doctors believe could affect how well the study drug works or how safely it can be given, including poorly controlled diabetes, active infections, or significant mental health conditions.
• People with severe neurological or psychiatric disorders, including dementia or seizures.
• People with significant nerve damage (peripheral neuropathy) rated at grade 2 or higher on a standard medical scale.
• People who are pregnant or breastfeeding.
• People with significant heart conditions, such as heart failure (grade II or higher), a heart attack within the past 3 months, unstable heart rhythm, or unstable chest pain. People with known heart disease or low heart pumping function may be considered if their condition is well managed and stable (confirm with trial site).

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