Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916248
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-06-02
Brief Title:
Personalized Tumor Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Clinical Study of Personalized Tumor Vaccines mRNA-0217S001 and Pembrolizumab in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-05
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:
The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217S001 vaccine encoding personalized tumor neoantigens alonein combination with Pembrolizumab injection for the treatment of advanced solid tumors The secondary objective was to observe the preliminary efficacy of mRNA-0217S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4 and CD8 T lymphocyte responses objective tumor response rate ORR and disease control rate DCR progression-free survival PFS and overall survival OS caused by mRNA-0217S001 personalized tumor vaccine
Detailed Description:
None
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