HARE-40

Title

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

Description

HARE-40 is a phase I/II vaccine dose escalation study for HPV16+ Squamous Cell Carcinoma.

Objectives

Primary objective

To establish a safe and tolerable dose of the HPV vaccine.

Secondary objectives

Looking at clinical effect in advance HPV-driven cancers and to assess if these clinical effects are linked with immune effects in the blood and tissue.

Trial Design

Each patient will progress through an intra-patient dose escalation for a total of 8 vaccinations, comprising of 4 weekly vaccinations and 4 fortnightly vaccinations. During this time, patients will be expected to stay overnight for a period of 24 hours after the vaccination. Patients will then be followed up for a period of 2 years, attending follow-up visits at regular intervals.

Trial Status

Closed to recruitment

Population

Initially, the trial will recruit to two Arms:

• Arm 1A will recruit 15 patients who have been previously treated for HPV16+ Head and Neck SCC.
• Arm 1B will recruit 29 patients with advanced HPV16+ SCC of Head and Neck, Penile, Cervical and Anogential.