Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01461148
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2011-10-25
Brief Title:
Vaccination Against MSI Colorectal Cancer
Sponsor:
Oryx GmbH Co KG
Organization:
Oryx GmbH Co KG
Study Overview
Official Title:
Phase IIIa Study of Immunization With Frameshift Peptides Administered With Montanide ISA-51 VG in Patients With Advanced MSI-H Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with advanced microsatellite unstable MSI-H colorectal cancer will be vaccinated with three so called frame shift peptides FSPs AIM2-1 HT001-1 and TAF1B-1 combined with Montanide ISA-51 VG By this an immune response directed against MSI-induced FSPs that are shared by the majority of MSI-H colorectal cancers can be induced The aim is to show that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses against MSI-H colorectal cancer-associated antigens
Detailed Description:
The present study is initiated to evaluate vaccination with MSI-specific FSPs in patients with MSI-H colorectal cancer Specifically the present study aims at the following questions
Evaluation of potential toxicity of the FSP AIM2-1 HT001-1 TAF1B-1
Evaluation of the immune response in patients with advanced MSI-H colorectal cancer before vaccination and after vaccination with the FSP AIM2-1 HT001-1 TAF1B-1
In this context the present study shall demonstrate whether application of FSP in a vaccination approach is associated with the induction of peptide-related toxicity Hence the study marks the first step towards the application of FSP in humans as it provides information on the safety of FSP as vaccination agents for the first time Moreover the study shall provide initial information whether vaccination with FSP can induce FSP-specific immune responses in patients with MSI-H colorectal cancer Thus it shall provide information whether FSPs AIM2-1 HT001-1 and TAF1B-1 have the potential to elicit peptide-specific immune responses and therefore represent suitable targets for the induction of tumor antigen-specific immune responses in patients with MSI-H tumors
The present study marks an important milestone towards a potential application of MSI-specific FSP as therapeutic agents in the management of patients with MSI-H tumors particularly patients with MSI-H colorectal cancer Long-term goal of this approach is to develop novel tools for 1 the palliative andor adjuvant therapy of patients with advanced MSI-H colorectal cancer and 2 the preventive application of FSPs in mutation carriers of the HNPCCLynch syndrome
Evaluation of potential toxicity of the FSP AIM2-1 HT001-1 TAF1B-1
Evaluation of the immune response in patients with advanced MSI-H colorectal cancer before vaccination and after vaccination with the FSP AIM2-1 HT001-1 TAF1B-1
In this context the present study shall demonstrate whether application of FSP in a vaccination approach is associated with the induction of peptide-related toxicity Hence the study marks the first step towards the application of FSP in humans as it provides information on the safety of FSP as vaccination agents for the first time Moreover the study shall provide initial information whether vaccination with FSP can induce FSP-specific immune responses in patients with MSI-H colorectal cancer Thus it shall provide information whether FSPs AIM2-1 HT001-1 and TAF1B-1 have the potential to elicit peptide-specific immune responses and therefore represent suitable targets for the induction of tumor antigen-specific immune responses in patients with MSI-H tumors
The present study marks an important milestone towards a potential application of MSI-specific FSP as therapeutic agents in the management of patients with MSI-H tumors particularly patients with MSI-H colorectal cancer Long-term goal of this approach is to develop novel tools for 1 the palliative andor adjuvant therapy of patients with advanced MSI-H colorectal cancer and 2 the preventive application of FSPs in mutation carriers of the HNPCCLynch syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None