Phase I/IIa Study of Immunization With a p16INK4a Peptide Combined With MONTANIDE ISA-51 VG in Patients With Advanced HPV-associated Cancers
The present study is initiated to evaluate vaccination with P16_37-63 -peptide in patients
with advanced HPV- and p16INK4a -positive cervical, vulvar, vaginal, penile, anal or head
and neck cancer. Specifically, the present study aims at the following questions:
- Evaluation of potential toxicity of the vaccination with P16_37-63 -peptide
- Evaluation of the immune response in patients with advanced HPV- and p16INK4a-positive
cervical, vulvar, vaginal, penile, anal or head and neck cancer before vaccination and
after vaccination with P16_37-63.
In this context, the present study shall demonstrate whether application of P16_37-63 in a
vaccination approach is associated with the induction of peptide-related toxicity. Hence,
the study marks the first step towards the application of P16_37-63 in humans, as it
provides information on the safety of P16_37-63 as vaccination agent for the first time.
Moreover, the study shall provide initial information, whether vaccination with P16_37-63
can induce p16INK4a -specific immune responses in patients with advanced HPV- and p16INK4a
-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer. Thus, it shall
provide information, whether P16_37-63 has the potential to elicit peptide-specific immune
responses and therefore represent a suitable target for the induction of tumor
antigen-specific immune responses in this population.
The present study marks an important milestone towards a potential application of P16_37-63
as therapeutic agent in the management of patients with advanced HPV- and p16INK4a -positive
cervical, vulvar, vaginal, penile, anal or head and neck cancer. Long-term goal of this
approach is to develop novel tools for the palliative and/or adjuvant therapy of patients
with advanced advanced HPV- and p16INK4a -positive tumors.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Immune response against peptide P16_37-63. A positive immune response is defined as positive DTH response against peptide P16_37-63 or a humoral (ELISA for the detection of p16-specific IgG/IgM/IgA) and/or CD8 and/or CD4 cellular (IFN gamma ELISpot for the detection of p16INK4a-specific T cells) immune response exceeding the assay specific cut-off values for a positive response against peptide P16_37-63.
every 2 weeks
Elke Jäger, Prof. Dr.
Krankenhaus Nordwest Frankfurt