Therapeutic HPV vaccine trial +/- anti-CD40 in HPV-driven squamous cell carcinoma

Not Applicable

Completed

• Conditions: HPV-driven squamous cell carcinoma; Cancer

• Registration Number: ISRCTN51789191
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-15
• Study Completion: 2024-01-24
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Arm 1A:<br> The suitable dose of HPV mRNA vaccine is based on defined criteria for DLTs (dose limiting toxicities). This is measured by evaluation of DLTs until 28 days after last study treatment.<br><br> Arm 1B:<br> Disease control rate, defined as the rate of complete response, partial response or stable disease, is measured according to irRECIST 1.1 at the end of treatment CT scan at Day 85.<br>