HighPole: A Phase 2 trial of a 6-week treatment schedule of neoadjuvant nivolumab and ipilimumab in operable MSI high or POLE exonuclease domain mutant colon cancer (CRC)

Study code 
CTU-6
Disease 
Colorectal Cancer
Recruitment 
Not yet open
Date 
01/09/2018
Status 
In set up

A Phase 2 trial of a 6-week treatment schedule of neoadjuvant nivolumab and ipilimumab in operable MSI high or POLE exonuclease domain mutant colon cancer (CRC).

This is an open label multi-centre phase II trial with the primary objective to determine preliminary evidence of efficacy after administering neoadjuvant nivolumab and ipilimumab over a 6-week schedule in operable MSI high or POLE exonuclease domain mutant colon cancer (CRC) patients. This will be carried out in three hospitals in the UK with 50 participants.

Secondary objectives include:

  • assessing the safety of 2 cycles of combination nivolumab and ipilimumab 3 weeks apart schedule in the neo-adjuvant setting
  • reporting the effects of nivolumab and ipilimumab in a neo-adjuvant setting through PFS, OS, pathological response and Quality of life. Translational work looking at immune related outcomes in MSI-High and POLE mutant CRC pre-and post-checkpoint inhibition. Investigations will include:
    • Profiling of circulating and tumour-infiltrating immune cell populations
    • Tumour phenotyping
    • TIL gene expression analysis
    • Tumour sequencing and prediction of neo-epitopes
    • Tissue for tissue microarray (TMA (paired))

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