NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab

As you probably know, Tim – but to help others reading, it looks as though patients in this trial will be given an anti-PD-1 product (named libtayo or cemiplimab made by Regeneron) intravenously and an intralesional (a cancer killing viral product, called Voyager V1, made by Vyriad, injected directly in to the tumor – much like CAVATAK or T-VEC). Despite finding a reference to the Phase 1 results having been presented, I have not found them. There are many adverts proclaiming the trial’s existence to investors, as is sadly typical in the world of ratties.

I did find this addressing V-V1 – https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3090 However, as Phase 1 studies are really only dosing studies (done to determine the highest dose that can be given that will get a response but stop short of having the rattie grow three heads – very familiar with these as my Nivo study was a Phase 1 trial) it doesn’t really address responses, focusing instead on the biomarker they are using and infusion reactions. No melanoma patients are used unless there were some lumped in the 11% with “other cancers”.

Here is a report noting that V-V1 is to be combined with an anti-PD-L1 product in a phase 2 trial for colorectal cancer patients: https://immuno-oncologynews.com/2018/07/27/vyriad-expands-phase-1-trial-testing-combination-voyager-v1-bavencio/

Here is some info on cemiplimab from its use in squamous cell carcinoma -seems to have the side effect profile expected for anti-PD-1 immunotherapy: https://dermnetnz.org/topics/key-clinical-trial-evidence-for-cemiplimab/

I don’t know that any of this helps you very much. If I run across anything more pertinent I will pass it on. I wish you my best with whatever you decide. celeste