NCT01462838

Immune Therapy of HPV-induced Cancers

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Oryx GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HPV-induced Cancers

Interventions

Type	Name	Description
BIOLOGICAL	P16_37-63	100 ug per application subcutaneously, mixed with 0.3 ml Montanide ISA-51 VG; once a week for four weeks, followed by a 4 week rest period (1 cycle), up to 3 cycles

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-01-01
• Completion: 2015-05-01
• First posted: 2011-10-31
• Last updated: 2015-06-23

Locations

1 site across 1 country: Germany