Clinical Trial vs. Standard Treatment Stage 4

Sapporo,

I am with you on this one. I am also 44 and recently went from resected stage 2 to stage 4 with lymph node involvement in the adomen and clavicular nodes. I was given options of Nivo, Pembro, Ippy/Pembro combo or clinical trial with Pembro and PV-10 intralesion injections. While the Ippy/Pembro combo might have been more aggressive, the possible side effects were also. I feel like at 44, there are more options if the trial is no bueno. Just my two cents worth and there are plenty of more learned folks on this board who can offer great insights. Wishing you the best, do everything you can to make an informed decision that is right for you and let the meds work their magic.

A little more information about your tumours would be helpful, like size, location ,are they surgically respectable, are they growing quickly, what is your Braf status. What other options have been suggested to you? ie. T-vek injection + pembro, Ido + pembrolizumab, Ipi/Nivo? What is your LDH level? Is your oncologist a melanoma specialist?

It's an interesting choice.  Nivo (and Pembro) have relatively mild side effectsm while il-2 has had probably some more ongoing negative ones  That's not to say Nivo/Pembro hasn't produced severe or worse side effects (classically, coilitis, thyroid damage, etc).  

I can't tell you what to do, but there are some questions/things to think about:

what your options are if you are on Nivo only and fail

Are you employed and/or do you plan to be busy/employed while being treated.  I can't imagine experiencing several IL-2 side effects while working or taking care of kids, etc.  YMMV here and others on this site have more experience than me.  I can tell you that I managed Pembro with ease and worked full time while on it.  Again, YMMV, as some struggle with the side effects.  

As others pointed out, there are other considerations as well – like alternative treatments, although right now, Nivo/Pembro is essentially the front line stage 4 drug.  

Good luck!

I have all of the same questions that Ed has. Something to consider and discuss with your doc is what are the advantages and disadvantages of the two options. I understand at 44 that you want to be as aggressive as possible. I was 44 when diagnosed stage IV with brain and lungs… that was early 2013… so hang in there! : )  As aggressive as I tend to be, I personally opted out of a brain lesion trial. Sometimes, trials are not necessarily the most aggressive treatment. There are times that trials are going after patients who have not yet been treated, to see if a particular combo works better than a solo agent or different combo. What phase is the trial in? Has it already been shown more effective than the single agent options, or "go to standard" of Ipi/Nivo? WHY does your doc feel that may be the better option over standard FDA approved treatments at this juncture? Will the trial be "off the table" as a choice if you go standard, and it doesn't work? While I have TREMENDOUS appreciation for the folks who were in trials to show docs and researchers what can be done, and what shouldn't be done….. I also have that cautious voice in my head that tells me to get answers before being the "test model". That said, I did participate in a research project which essentially extended me long enough to make it to FDA approval of a standard treatment that ended up being quite effective for me (Keytruda)… buuuuut… i was at that "continue to hang on or try this" point. I'm happy that I did it, and it was nice to see what was learned from it… but as I mentioned, I also turned down a trial involving brain lesion treatment, and I am SUPER thrilled that I didn't leap into that one. Know the details of the trial, so you can make an informed decision on what is best for you. What phase is it in? What are the requirements? How will it differ from the current standard? What are researchers trying to determine at this phase? Is it indeed more aggressive, or is this what they are seeking to find out? What are the potential downfalls? What is the time frame?