Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05641545
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2022-05-02
Brief Title:
IVAC-RCC-001 A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in AdvancedMetastatic RCC Patients
Sponsor:
SLK Kliniken Heilbronn GmbH
Organization:
SLK Kliniken Heilbronn GmbH
Study Overview
Official Title:
IVAC-RCC-001 A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in AdvancedMetastatic RCC Patients
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Premature discontinuation due to üoor participant recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a monocenter single-arm prospective phase Ib trial designed to evaluate the safety clinical toxicity and in vivo immunological effects of a patient-individualized peptide vaccination added to standard of care checkpoint blockade nivolumab in adult patients with metastaticadvanced renal cell carcinoma who experienced at least stable disease after four cycles of standard of care immune therapy ipilimumabnivolumab
Detailed Description:
The aim of this clinical study is to evaluate the feasibility and safety of an individualized peptide vaccination approach in patients with advanced renal cell carcinoma who experienced at least stable disease after four cycles of standard of care immune therapy ipilimumabnivolumab For this purpose tumor-specific mutations are analyzed by comparative exome sequencing of tumor and healthy reference tissue In a second step HLA-binding human leukocyte antigen-binding peptides derived from mutated protein sequences are selected for vaccination The peptides are administered as a vaccination cocktail with adjuvant GM-CSF and Imiquimod over a course of 9 months and a total of 16 vaccinations Primary objective is the de novo induction of a specific T cell response without unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None