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, of any gender.
• People who are able and willing to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study.
• People who have been diagnosed with a specific type of throat cancer called oropharyngeal squamous cell carcinoma, confirmed by laboratory analysis of a tissue sample.
• People whose cancer has been confirmed to be caused by the HPV16 strain of the human papillomavirus, tested by a central laboratory or a local lab (with central lab confirmation to follow).
• People whose overall health and ability to carry out daily activities meets a specific standard, rated 0 or 1 on a scale used by doctors to measure this (confirm with trial site).
• People who have completed full curative treatment for their cancer at least 16 weeks before the study drug would be given, with 18 to 20 weeks being the recommended gap.
• People who show no signs of remaining or returning cancer on their most recent assessment, which includes a physical examination, head and neck scans, and a chest scan (and a PET scan for those treated without surgery).
• People whose recent blood test results fall within required ranges for white blood cells, infection-fighting cells, platelets, haemoglobin, kidney function, and liver function, tested within 14 days before joining the study.
• People born female who test negative for pregnancy before joining and on the first day of treatment, and who use effective contraception throughout the study and for 4 months after the last dose — or who are not able to become pregnant.
• People born male who are sexually active with a female partner and who use effective contraception from the first dose until 4 months after the last dose (this also applies to sperm donation).
• People who have read, understood, and signed the informed consent form before any study procedures begin.
• People who are covered by a social security or equivalent health system (relevant to the country where the trial is conducted).

Who may not be able to join:

• People who show any sign of remaining or returning HPV-related cancer at the original site, in neck lymph nodes, or anywhere else in the body.
• People with a serious or uncontrolled medical condition that, in the treating doctor's view, could increase risks, interfere with treatment, or affect the study results.
• People with an active, known, or suspected autoimmune disease — though people with certain limited conditions such as vitiligo, type 1 diabetes, thyroid conditions managed with hormone replacement only, or psoriasis not needing systemic treatment may still be considered eligible (confirm with trial site).
• People with active lung inflammation (interstitial lung disease or pneumonitis), or a history of this condition in the past 5 years, or people currently taking high-dose steroid or immunosuppressive medications (confirm with trial site for specific thresholds).
• People currently requiring ongoing treatment with high-dose steroid medications, or who have recently taken a short course of high-dose steroids without stopping at least 2 weeks before starting the study.
• People who have previously received a therapeutic vaccine targeting HPV.
• People who have had major surgery requiring general or spinal anaesthesia and a hospital stay within 28 days before starting the study.
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection.
• People with an active infection at the time of enrolment — participation may be reconsidered once the infection has resolved.
• People with significant or uncontrolled heart conditions, such as a specific heart rhythm abnormality or severe heart failure (confirm with trial site for specific criteria).
• People who have had an organ transplant, including bone marrow or stem cell transplants.
• People who have taken part in another clinical trial involving an experimental treatment in the past 6 months, or who are currently in another such trial.
• People who have received a COVID-19 or flu vaccine within 4 weeks before the first study vaccination (or within 2 weeks for flu vaccine during flu season).
• People who have received certain medications or treatments within the restricted time periods set by the study, including curative cancer treatment, corticosteroids, live or non-live vaccines (other than the study vaccine), immunosuppressive drugs, blood products, immunoglobulins, anti-tuberculosis drugs, immunomodulators, or fever-reducing medications taken within 12 hours before an injection as a preventive measure.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People who are under legal guardianship, have had their liberty restricted by a legal or administrative decision, or are unable to give informed consent.

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