Find Support

NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Content within the patient forum is user-generated and has not been reviewed by medical professionals. Other sections of the Melanoma Research Foundation website include information that has been reviewed by medical professionals as appropriate. All medical decisions should be made in consultation with your doctor or other qualified medical professional.

NCT04291105 Phase 2 Trial of Voyager V1 in Combination With Cemiplimab

Posted By
TimCT
7/28/2020 11:27am
View other posts by
Activity
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!

Tim

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-...

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

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.

https://clinicaltrials.gov/ct2/show/NCT03767348?term=RP1