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NOT YET RECRUITING
NCT05909423
PHASE2

Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer

Sponsor: Zealand University Hospital

View on ClinicalTrials.gov

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.

Official title: Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer - the FLU-IMMUNE Trial.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2023-09-01

Completion Date

2028-09-01

Last Updated

2023-06-18

Healthy Volunteers

No

Interventions

DRUG

Influenza vaccine

Intratumoral influenza vaccine treatment, administered via endoscopic procedure

DRUG

Pembrolizumab

Single dose pembrolizumab treatment

Locations (1)

Center for Surgical Science, Department of Surgery, Zealand University Hospital

Koege, Region Sjælland, Denmark