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 aged 18 or older (or the legal age of consent in their country, whichever is higher) at the time of signing the consent form
• People with a confirmed diagnosis of head and neck cancer (specifically in the oropharynx — the middle part of the throat) that has returned or spread, cannot be cured by local treatment, and where treatment with pembrolizumab alone is considered appropriate
• People whose oropharyngeal cancer has tested positive for HPV16, confirmed by the trial's central laboratory
• People whose cancer tests positive for a protein called PD-L1 (with a score of 1 or higher), measured using a specific approved test
• People whose primary cancer is located in the oropharynx (the middle part of the throat)
• People who have at least one measurable area of cancer detectable on imaging scans
• People who are generally well enough to carry out light activity and care for themselves (performance status of 0 or 1 on a standard medical scale)
• People whose blood platelet count, neutrophil count, and haemoglobin levels meet the minimum required levels (confirm with trial site for exact values)
• People whose liver function test results — including bilirubin, AST, ALT, and alkaline phosphatase — fall within acceptable ranges (with some allowance for those with liver spread or a condition called Gilbert syndrome)
• People whose blood clotting results are within an acceptable range, or within the intended treatment range if already on blood-thinning medication
• People whose kidneys are functioning at an adequate level, based on a standard calculation of kidney filtration rate
• Women who could become pregnant must have a negative pregnancy blood test taken within 72 hours before starting the trial
• Women who could become pregnant must agree to use highly effective contraception starting 14 days before treatment (for oral contraception), continuing for at least 120 days after the last dose of pembrolizumab and up to 6 months after the last dose of VB10.16, whichever is later
• Men must agree to use condoms during sexual activity throughout the trial and for up to 3 months after the last dose of VB10.16, and must not donate sperm during that same period
• People who are able to give informed consent must sign and date a written consent form before any trial-related procedures begin

Who may not be able to join:

• People whose cancer could still be treated with the aim of curing it using local treatments
• People whose cancer got worse within 6 months of finishing chemoradiotherapy that was intended to cure locally advanced oropharyngeal cancer
• People whose primary cancer is located in the mouth, lower throat (hypopharynx), voicebox (larynx), or the area behind the nose (nasopharynx)
• People whose cancer is considered to be rapidly progressing — for example, with tumour bleeding or pain that cannot be controlled — in the treating doctor's opinion
• People who have had palliative radiotherapy within 2 weeks before starting the trial, or who have a history of radiation-related lung damage
• People who have previously received any approved or investigational cancer drug treatment (including immunotherapy) for cancer that has returned or spread
• People who have had a solid organ or tissue transplant in the past (except for a corneal transplant)
• People who have had a stem cell transplant (either using their own or a donor's cells)
• People who have previously had CAR-T cell therapy (a type of specialised immune cell treatment)
• People who have previously received certain antibody-based treatments that work by activating T-cells (a type of immune cell)
• People who have received a live or live-attenuated vaccine within 30 days before the first trial treatment
• People who have received a COVID-19 vaccine within 30 days before starting VB10.16
• People who have previously received any therapeutic HPV16 vaccine
• People currently taking systemic immunosuppressant medications such as cyclosporine, azathioprine, methotrexate, or TNF-alpha blockers
• People taking corticosteroids (such as prednisone) at a dose greater than 10 mg daily on an ongoing basis
• People who have received growth factor injections (G-CSF/GM-CSF) or blood product transfusions within 2 weeks before starting VB10.16
• People who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or similar checkpoint immunotherapy drugs (such as drugs targeting CTLA-4, OX40, or CD137)
• People who have had surgery within 4 weeks before starting trial treatment
• People who have major surgery planned during the trial period
• People with a current or past cancer other than the cancer being studied, with some exceptions (such as certain cancers treated successfully at least 3 years ago with no signs of return, or certain treated skin, breast, cervical, bladder, or prostate conditions with no signs of active disease — confirm with trial site)
• People with any current bleeding disorder, active bleeding, or problems with blood clotting
• People with significant heart conditions, including moderate-to-severe heart failure, unstable chest pain, or uncontrolled heart rhythm problems
• People who have had a heart attack within 6 months before starting VB10.16
• People with high blood pressure that is not controlled despite treatment (readings of 160/100 mmHg or higher)
• People with any other significant heart condition considered clinically important by the treating doctor
• People with a history of non-infectious lung inflammation (pneumonitis) or scarring of the lung (interstitial lung disease) that required steroid treatment, or who currently have this condition
• People with a primary immune system disorder, other immunosuppressive condition, or other cause of reduced immune function
• People who have an active autoimmune disease (where the immune system attacks the body) that has required systemic treatment within the past 2 years — note that hormone or other replacement therapies (such as thyroid medication or insulin) are not counted as systemic treatment
• People with a known history of HIV infection
• People with a known history of active Hepatitis B or active Hepatitis C infection
• People with any active, uncontrolled infection requiring systemic treatment
• People with known allergies or sensitivities to VB10.16, pembrolizumab, or a class of antibiotics called aminoglycosides (especially kanamycin)
• People with a history of blood vessel abnormalities in the brain, brain aneurysm, or stroke
• People with active cancer spread to the brain or lining of the brain — though people with previously treated, stable brain metastases may be considered if specific stability criteria are met (confirm with trial site)
• People with new (within 6 months), worsening, or symptomatic cancer spread to the brain
• People currently participating in, or who have previously participated in, another clinical trial involving an investigational treatment for cancer that has returned or spread
• People with any condition, treatment history, or other circumstance that the treating investigator believes would interfere with the trial or make participation not in the person's best interest
• People with a known psychiatric condition or substance use disorder that would affect their ability to participate in the trial
• People requiring blood-thinning medication at a level that the treating doctor believes would make the study treatments or tumour biopsies unsafe
• Women who are pregnant or breastfeeding

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