Clinical Trials Directory

Trials / Completed

CompletedNCT03418480

HARE-40: HPV Anti-CD40 RNA vaccinE

Therapeutic HPV Vaccine (BNT113) Trial in HPV16 Driven Carcinoma

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Southampton · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

HARE-40 is a phase I/II vaccine dose escalation trial with two arms (Arm 1A and Arm 1B) in which we will test BNT113 as monotherapy. We will undertake a multi-centre phase I, open label trial in patients with previous HPV16+ HNSCC without current clinical evidence of disease (Arm 1A) and in patients with HPV16+ advanced disease (Arm 1B). The HPV16 antigen-specific immune response will be evaluated before and after treatment in circulating blood and, where samples have been collected, in tumour and skin biopsies. Arms 1A and 1B will escalate BNT113 in each patient (intrapatient dose escalation) up to the specified target dose of the cohort to establish a safe, tolerable and recommended dose of BNT113 in patents who are disease free (Arm 1A) and those with advanced disease (Arm 1B). Subset of patients in Arm 1B will also be assessed for response to the vaccine in terms of a significant increase of immune cells following BNT113 administration and according to irRECIST1.1 (all 29 patients including the expansion cohort) and other endpoints.

Conditions

Interventions

TypeNameDescription
DRUGBNT113Intradermal vaccine

Timeline

Start date
2017-04-11
Primary completion
2023-11-01
Completion
2024-01-24
First posted
2018-02-01
Last updated
2024-02-07

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03418480. Inclusion in this directory is not an endorsement.