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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05909423
Study type Interventional
Source Zealand University Hospital
Contact Ismail Gögenur, Professor, DMSc
Phone 26336426
Email igo@regionsjaelland.dk
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2023
Completion date September 1, 2028

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