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October 16, 2013 at 4:20 pm #21628
I have stage 3C nodular melanoma, one of my nodes was completely involved two were microscopically. I had surgery 5wks ago, where I had clean margins and everything is healing well. Now, I’m on to decision time. I tested postive for the BRAF gene and I need to choose between two clincials.
A. The interferon vs. Yeravoy using lower dose of Yeravoy
B. The BRAF combination clincal (the one where you recieve a BRAF inhibitor and MERK (i think it is called)
I have a basic understanding of the side effects for w/ interferon (terrible) and Yeravoy but want to understand the BRAF trial a bit more since it is a 50/50 chance that I will get a placaebo. I’m 41yrs old woman w/ young kids and I have want be proactive. I have changed my eating habits (no meat and little dairy, lots of plants) but my diet wasn’t that bad in the first place.
I have searched the forum but didn’t see if there was a topic on this two trials, perhaps I missed it. I need to make a decision by the end of October and I’m just not sure what the best road is to take. any advice would be appreciated.October 16, 2013 at 6:55 pm #62747
Do you know which BRAf/Mek trial it is? Do you get the active drug? I would probably head to that as you can get Yervoy by prescription and the overall survival for interferon is not terribly good. Let me know which trial it is so I can help further.October 17, 2013 at 2:02 am #62748 The BRAF trial is combination of Dabrafenib and MEK in Trametinib. With this trial you either get two drugs or nothing at all and it is a double blind. I’m still waiting to recieve the clinical information from my docto. I do know the side effects are squamous skin cancer, and sensitivity to the son, but have you heard other issues?October 17, 2013 at 2:40 am #62749 I think you are talking about the GSK NCT01682083 adjuvant trial which I think is quite new. Four months ago when my husband (3C nodular as well) was making his decision the choice was the Ipi (2 doses then) vs interferon or if he was B-Raf positive (which he’s isn’t) vermurafenib vs placebo. You may find more info on the side effects from people in the stage IV forum since these haven’t been used much in the adjuvant setting.
If you are Stage 3 resected you cannot receive Ipilimumab (or the various Braf/MEK inhibitors) outside of a trial. It is a difficult decision because in both trials you now have a 50/50 chance of not getting the study medication. In the Ipi/Interferon you will know what you receive. For the BRaf it is blinded. I don’t know what the protocol says about when it might be unblinded (if there was recurrence would you know what you had received?)
I wish you all the best in making the decision that is right for you,
KatieOctober 17, 2013 at 6:04 pm #62750
Just an update on the trials from our visit to the doctor today. Apparently, there is a temporary suspension of accrual for the Ipi vs Interferon clinical trial. This is a result of the closing of the 10mg arm and the need to reassess things. Also, according to our clinical trial coordinator they have been seeing “immediate toxicity” with the adjuvant Braf trials….no details other than in general for all the adjuvant trials there seems to be increased toxicity over the stage IV experience. Obviously, this is just anecdotal. Take home lesson for us was, know thy side effects.
Again, good luck with your decision
KatieOctober 18, 2013 at 12:28 pm #62751
I wonder if this is just a suspension where you are going? I’m going to double check with the pharma. Also, immediate toxicity with the braf agent? I will also verify if that is true across all centers. I don’t want to discourage folks from participating.October 18, 2013 at 4:00 pm #62752 My understanding was that accrual was suspended across the whole of the trial. I was not trying to dissuade anyone from participating only to make sure they know and understand the side effects (something the original poster was inquiring about). We have been fortunate to have a team that identifies potentially serious side effects quickly and addresses them quickly. This is very important (and another reason to see a melanoma specialist). In my reading of the forum prior to my husband’s decision to participate in a trial, there was some indication by posters that in the adjuvant trials side effects would be minimal. From my understanding this has not been the case (across locations). There are absolutely no regrets on my husband’s part for participating in the trial (despite some potentially serious side effects). He would do it again in a heart beat. I thought the post might be helpful….sorry if it wasn’tOctober 18, 2013 at 5:18 pm #62753 No I appreciate the information, just need to verify it from the pharma. I learn the most from patients and their caregivers! ThanksOctober 19, 2013 at 1:44 pm #62754 I checked with GSK on the BRAF/Mek adjuvant and found no issues there with the trials proceeding. I’m not sure what the nurses meant by immediate toxicity. Maybe they meant immediate side effects? There are some pretty early on but can be rectified usually with other meds and lower dosages. Will find out more about suspension of the Yervoy/Interferon trials soon.October 19, 2013 at 2:52 pm #62755LinnyParticipantCatherine Poole wrote:
I checked with GSK on the BRAF/Mek adjuvant and found no issues there with the trials proceeding. I’m not sure what the nurses meant by immediate toxicity. Maybe they meant immediate side effects? There are some pretty early on but can be rectified usually with other meds and lower dosages. Will find out more about suspension of the Yervoy/Interferon trials soon.
With regard to the Yervoy/Interferon trial, an individual reported on Melanoma Research Foundation’s board that the 10mg Yervoy arm of that trial was suspended due to some deaths that had occurred as a result of toxicity. As a result, the individual’s husband was arbitrarily moved to the Interferon arm of the trial rather than the lower dose Yervoy arm. Her husband was doing fine with the 10mg Yervoy dose and both were very upset about being moved to the Interferon arm as opposed to the lower dose Yervoy arm of the trial.
I hope we’re talking about the same trial.October 22, 2013 at 9:10 pm #62756
Just coming back to say that I met w/ my doctor yesterday and he suggest the Interferon/Yervoy trial for my case because of the primary melanoma pathology (12mm), ulcerated, satellite melanoma formed and moved to one node. He states that there is a 70-80% chance of return and he didn’t feel comfortable with the possibility of me getting a placebo on the BRAF/Mek trial. He also mentioned that BRAF / Mek is good to have in your back pocket so to speak in case it does come back and we talked about the possibility of developing a resistance to the drug. I know that the interferon is not a good option so I’m hoping for Yervoy (finger’s crossed). And yes this trial only has two arms, the Yervoy 3, the Yervoy 10 has been removed or halted due to toxicity. It is a scary propisition but being in the adjuvant setting, I feel that I need to do as much prevenative as possible.October 23, 2013 at 7:50 pm #62757 The options aren’t wonderful, but at least there are some! Let us know how things turn out!August 9, 2014 at 8:23 pm #62758greenshaekParticipant Hello, I’m also looking at participating in the Braf/Mek combi trial (COMBI AD) for my stage 3b melanoma. I keep hearing everywhere that people are concerned about becoming resistant to the drug and needing it later. This leads me to wonder how Braf/Mek inhibitors work in the first place. As far as I have understood, they can very quickly shrink tumours … but after 6 to 9 months it doesn’t work any more. Why is that? And how could that be a possibility in an adjuvant setting? Surely the Braf/Mek drugs would wipe out any melanoma traces, or am I missing the point here?August 10, 2014 at 2:53 pm #62759LinnyParticipant The primary outcome measure they’re looking at for this trial is relapse-free survival time. So it sounds like they want to determine if this combo can nip melanoma in the bud. You’re on the drug (or placebo) for a year and they are not designating it as a safety issue. So, they are looking to answer the question you asked.
Something else to keep in the back of your mind is that in these forums you tend to hear more from people who have “failed” a BRAF inhibitor like Zelboraf than from those for whom it’s working. That’s because the ones who have “failed” are usually seeking alternate options while the others are going on with their lives.August 10, 2014 at 3:33 pm #62760
Good questions! Here is a really good article that explains how the BRAF inhibitor works and that in fact may be more useful in palliative scenarios than curative. BUT, in combination with the new immunotherapies, we may get a homerun. Here’s the article (a little dated, but good) http://www.dfhcc.harvard.edu/news/news/article/4124/
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