Spots Global Cancer Trial Database for Immune Therapy of HPV-induced Cancers

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Trial Identification

Brief Title: Immune Therapy of HPV-induced Cancers

Official Title: Phase I/IIa Study of Immunization With a p16INK4a Peptide Combined With MONTANIDE ISA-51 VG in Patients With Advanced HPV-associated Cancers

Study ID: NCT01462838

Conditions

HPV-induced Cancers

Interventions

P16_37-63

Study Description

Brief Summary: Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can be induced. The aim is to show that vaccination with P16_37-63 is safe and can induce or enhance immune responses against p16INK4a.

Detailed Description: 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.