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NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab

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NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab

Posted By
7/28/2020 11:27am
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Replies: 3

Hi All,

Anyone have any info on this one? My doc is trying to get me into this one, after progressing while on ipi/nivo and before we try taf/mek. The intratumoral approaches are very interesting, I'd be very interested in seeing if any data from phase 1 has been made available. Thanks for any help!


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 - 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:

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:

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

Thanks Celeste, so appreciate your help!

TimCT, There is another trial that my mom is considering after failing ipi/nivo here is the link. This is basically herpes virus injected into tumor with opdivo infusions. I am not sure if anyone here has tried this.