Clinical Trials > Head and Neck > REALISTIC >> Information

Title

A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Serotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma

Basic Trial Information

Purpose

HPVs are obligate human pathogens, some have the propensity to promote malignant transformations of their host cells. An example of this is HPV-16 in the oropharyngeal squamous cell carcinoma, which is seen in about 50-70% of cases although there is geographical variation.

ADXS11-001 (formerly Lovaxin C) is a bioengineered strain of living Listeria monocytogenes that induces a strong therapeutic immune response using multiple mechanisms of action. This vaccine secretes the tumour antigen HPV-16 E7 fused to an attenuated Lm virulence factor, Listeriolysin O (LLO), which has strong adjuvant properties.

If proved safe, there is a role for ADXS11-001 as a post-treatment adjuvant as part of a treatment de-escalation strategy in an attempt to reduce the adverse effects of current treatment strategies without compromising survival. The REALISTIC trials' objective is to determine safety and to characterise the toxicity profile of ADXS11-001.

Trial Lead Organisations

LCTU / CR-UK

Official Title

A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Serotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma

Trial Start Date

23/12/2012

References

Trial Coordinator

Gemma Simpson

Trial Coordinator Email Address

g.simpson@liverpool.ac.uk

Trial Coordinator Contact No

0151 794 8974