Anyone with experience with MAVIS vaccine trial - testing the drug POL-103A (the trial number is NCT01546571)

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8/17/2013 5:18pm
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This trial has been recommended for my niece.  Just wondering if anyone has any experience with this trial?  For background - my niece is stage IIC - diagnosed with a pink melanoma - 4.24mm deep, ulcerated with a mitotic rate of 9.  It seems like interferon is not a great choice.  I know it is controversial but wondering what the pros and cons might be of each treatment.  Thanks so much!

Many researchers have attempted to develop a melanoma vaccine for decades. All such vaccines have failed. However, as melanoma in general and the immune response to melanoma in particular is better understood, new and more promising vaccines keep being introduced.

This company, Polyoma, claims that their Phase 1 and 2 trials of the POL-103A vaccine showed that the vaccine is "safe and effective" and extends the life of melanoma patients so they started a Phase 3 trial (2/3 experimental, 1/3 placebo) last year. I don't see that the company has ever published the results of their Phase 1/2 trials, which makes me wonder about how solid the data are. On the othe hand, Phase 3 trials are very expensive, so why would the company do a Phase 3 without solid Phase 2 data? 

I guess all this is to say that I don't think that anybody can say with any certainty that POL-103A is going to work. However, it might work and the side effects should be minimal. Interferon is known to work, but only in a small percentage of patients and it has some miserable side effects. One big advantage of a clinical trial is that the patient is followed very closely for a long time by people who know a lot about melanoma. That would be a major consideration for me. 

Hi, just doing some research on that trial, did your niece do it?  We hope my husband can get into another trial where you get interferon or keytruda, but it was temporarily postponed and our 98 day window of opportunity is getting smaller and smaller.  Otherwise, he will reluctantly do interferon.  He had primary tumor stage 2b with ulceration in 2014 then recurrence in lymph nodes in May 2016 with two malignant tumours after his neck dissection in June.  Looking for the best treatment plan moving forward...

Any updates would be greatly appreciated.

Kind regards, 

Delores and George