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 to 74 years old
• People with a confirmed diagnosis of squamous cell cancer of the head and neck (mouth, throat, or voice box) that has come back or spread, and cannot be treated with surgery or radiation aimed at curing it; or people with squamous cell cancer of unknown origin if it tests positive for HPV
• People whose cancer tissue tests positive for a protein called PD-L1, with a score of 1 or higher on a specific lab test
• People who are able to carry out normal daily activities with little to no limitation (based on a standard fitness scale used in cancer care)
• People who have no medical reasons preventing them from receiving the combination of chemotherapy drugs (TPEx regimen, using either cisplatin or carboplatin), the drug cetuximab, or the immunotherapy drug avelumab
• People with oropharyngeal (throat) cancer whose tumour has been tested for a marker called p16, which indicates HPV status
• People whose cancer can be measured on a CT or MRI scan
• People who had radiation therapy without chemotherapy, where that treatment finished at least 4 weeks before starting this trial (or at least 2 weeks if it was palliative radiotherapy)
• People whose recent blood and organ function tests fall within the required ranges, taken within 14 days before eligibility is checked (confirm with trial site for specific values)
• People whose calcium levels are within the normal range at the time of joining (medical management to achieve this is allowed)
• People who have recovered from side effects of any previous treatments, back to their normal baseline or to a mild level, before joining
• Women who could become pregnant must have a negative pregnancy test taken within 72 hours before the eligibility check
• People who are sexually active must agree to use highly effective contraception from the time of signing the consent form until at least 7 months after finishing treatment (for women) or 4 months after finishing treatment (for men)

Who may not be able to join:

• People who have previously received systemic chemotherapy for head and neck cancer, unless it was given as part of combined treatment for locally advanced disease that was completed more than 6 months before joining
• People with confirmed returning or spreading cancer of the nasopharynx, HPV-negative cancer of unknown primary origin, salivary gland cancer, or non-squamous cell cancers (such as mucosal melanoma)
• People with a serious or uncontrolled medical condition that, in the investigator's opinion, could increase risks, affect the ability to receive the study treatment, or affect how results are interpreted
• People who have had another active cancer in the past 3 years, except for certain slow-growing or apparently cured cancers such as some skin cancers, superficial bladder cancer, or early-stage cancers of the prostate, cervix, or breast
• People with an active, known, or suspected autoimmune disease (some stable, well-managed conditions may still be eligible — confirm with trial site)
• People who require regular daily use of corticosteroid tablets or other immune-suppressing medications (above a certain dose) within 14 days before eligibility is checked; inhaled or topical steroids may be permitted (confirm with trial site)
• People who have previously been treated with immunotherapy drugs that target the PD-1 or PD-L1 pathways, or similar checkpoint therapies
• People who received anti-EGFR treatment less than 6 months before the eligibility check
• People with a known positive HIV test or AIDS diagnosis
• People with active or chronic hepatitis B or hepatitis C infection based on positive test results
• People who received a live virus or live bacteria vaccine for infection prevention within 4 weeks before the eligibility check (inactivated flu vaccines are allowed)
• People with a history of severe allergic reactions to any human monoclonal antibody
• People with severe psychiatric conditions that would make it difficult to follow the study requirements
• People who required hospitalisation and intravenous antibiotics for a serious infection within 14 days before the eligibility check
• People who have had an organ transplant
• People with a bleeding tumour, if carboplatin is the chemotherapy being used
• People currently taking the seizure medications phenytoin or fosphenytoin during the treatment period
• People with a history of allergy to red meat or tick bites, or who test positive for a specific antibody (IgE against alpha-1-3-galactose) related to cetuximab
• People with a lung condition called interstitial lung disease
• People with a history of uncontrolled or symptomatic heart disease
• People who are under a court or administrative restriction on their liberty, or under any form of legal guardianship

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