HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine.
Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Arm 1A:
* Previous HPV16+ head and neck squamous cell carcinoma.
* At least 12 months after completion of treatment.
* Within 5 years of treatment completion.
* Currently no clinical evidence of disease.
* ECOG performance status 0 or 1.
Arm 1B:
* HPV16+ head and neck, cervical, anogenital and penile carcinoma patients with recurrent disease.
* Intention to treat is palliative.
* Patient willing to have repeated tumour biopsies and re-biopsy deemed safe and feasible clinically.
* Tissue samples available confirming HPV16+ disease to send to Central Laboratory.
Exclusion Criteria:
* Patients unable to consent.
* Any patient who has been previously vaccinated in any Arm of the trial.
* \<18 years
* Systemic steroids (prednisolone \>10 mg/day or equivalent) or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry. Replacement steroids for adrenal insufficiency/failure are allowed.
* Major surgery in the preceding three to four weeks, which the patient has not yet recovered from.
* Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.
* Patients with clinically relevant autoimmune disease will be excluded.
* Patients who are known to be allergic to any of the excipients or constituents of the vaccine
* Patients with any other condition which in the Investigator's opini…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity (DLT) according to CTCAE version 4.03 (Arm 1A)