ISRCTN51789191Completed未知
Therapeutic HPV vaccine (BNT113) trial in HPV16 driven carcinoma
niversity Hospital Southampton NHS Foundation Trust0 sites15 target enrollmentStarted: December 15, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria Arm 1A:
- •1. Previous HPV16+ head and neck squamous cell carcinoma
- •2. At least 12 months after completion of treatment
- •3. Within 5 years of treatment completion
- •4. Currently no clinical evidence of disease
- •5. ECOG performance status 0 or 1
- •6. Able to provide written informed consent
- •Inclusion Criteria Arm 1B:
- •1. HPV16+ head and neck, cervical, anogenital and penile carcinoma patients with recurrent disease.
- •2. Intention to treat is palliative.
- •3. Patient willing to have repeated tumour biopsies and re-biopsy deemed safe and feasible clinically.
- •4. Tissue samples available confirming HPV16+ disease to send to Central Laboratory.
Exclusion Criteria
- •1. Patients unable to consent
- •2. Under 18 years of age
- •3. Systemic steroids 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.
- •4. Major surgery in the preceding three to four weeks, which the patient has not yet recovered from
- •5. Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection
- •6. Patients with any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
- •7. Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study
- •8. Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing
- •9. Patients who have a positive pregnancy test
- •10. Fertile males or females who are unable or unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, intrauterine device, or intrauterine hormone-releasing system) during study treatment and until end of treatment +28 days (day 113)
- •11. Elevated Liver Function Tests – ALT, AST, Bilirubin
- •12. Any other investigational drug within 28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study
Investigators
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