Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909423
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-18
Brief Title:
Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer - the FLU-IMMUNE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
FLU-IMMUNE
Brief Summary:
Immune checkpoint inhibitor ICI treatment has produced striking results in patients with colorectal cancer CRC of the subtype deficient mismatch repair dMMR The majority of patients however have proficient MMR pMMR tumors with limited effect of ICIs The key difference between dMMR and pMMR tumors is the infiltration of cytotoxic T-cells dMMR tumors have increased infiltration and thus increased efficacy from ICI treatment The investigators conducted a proof of concept study where the investigators applied an intratumoral IT unaltered flu vaccine in ten patients with non-metastatic pMMR CRC The intervention increased infiltration of cytotoxic T-cells and the immune checkpoint PD-L1 suggesting that IT flu vaccine primes pMMR tumors to ICI treatment The investigators aim to test the combination of IT flu vaccine and ICI treatment in patients with non-metastatic pMMR CRC in a new trial The hypothesis is that IT flu vaccine and ICI treatment will synergistically to induce cancer cell death
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?:
False
Is an FDA AA801 Violation?:
None