› Forums › General Melanoma Community › Stage 3 trial
- This topic has 27 replies, 6 voices, and was last updated 9 years, 8 months ago by
Kenny.
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- June 10, 2014 at 4:24 am
This is my first post, I have read a lot on this forum recently and have been very thankful for the content.
I found out on March 25, 2014 that I have melanoma. What started out as a very small spot on my upper left back about the size of a pencil tip has turned into stage 3a melanoma. It was also found in one lymph node under my arm. I had a axillary lymph node dissection on April 25th and no melanoma was found. I had the melanoma tested for the BRAF mutation and I do. I have been looking into treatment and have this as an option.
Does anyone have any experience with this trial? I have a meeting on Monday June 16th to go over the details.
Thank you,
Ken
GSK BRF115532
A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after
Key Eligibility:
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Completely resected histologically confirmed high-risk Stage IIIa, IIIb or IIIc
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Must be surgically rendered free of disease no more than 12 weeks before randomization
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BRAF V600E/K mutation positive
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No prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy,
vaccine therapy, or investigational treatment) or radiotherapy for melanoma allowed. For more information: NCT01682083
- Replies
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- June 10, 2014 at 9:57 am
Adjuvant treatment is an area that needs so much attention. I think part of the problem is the duration of the studies. (It was 12 years before my Melanoma returned) I noticed in Tim's summary of the ASCO presentations below that a trial with Ipi in the adjuvant setting had a statistically lower rate of reoccurrence. In theory I suppose, the Ipi boosts the immune response and enables your body to hunt down any remaining cells. Curious about the Braf and MEK inhibitors in this setting since the full blown disease often develops a workaround. It may be that with so much less disease to fight these drugs are more overpowering– I've also heard of trials with vaccines for adjuvant care (debatable results) I don't have a position on this– except I, like you, would be looking for an adjuvant trial and wanted to point out the recent data in case you missed it. Wishing you good luck
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- June 10, 2014 at 9:57 am
Adjuvant treatment is an area that needs so much attention. I think part of the problem is the duration of the studies. (It was 12 years before my Melanoma returned) I noticed in Tim's summary of the ASCO presentations below that a trial with Ipi in the adjuvant setting had a statistically lower rate of reoccurrence. In theory I suppose, the Ipi boosts the immune response and enables your body to hunt down any remaining cells. Curious about the Braf and MEK inhibitors in this setting since the full blown disease often develops a workaround. It may be that with so much less disease to fight these drugs are more overpowering– I've also heard of trials with vaccines for adjuvant care (debatable results) I don't have a position on this– except I, like you, would be looking for an adjuvant trial and wanted to point out the recent data in case you missed it. Wishing you good luck
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- June 10, 2014 at 9:57 am
Adjuvant treatment is an area that needs so much attention. I think part of the problem is the duration of the studies. (It was 12 years before my Melanoma returned) I noticed in Tim's summary of the ASCO presentations below that a trial with Ipi in the adjuvant setting had a statistically lower rate of reoccurrence. In theory I suppose, the Ipi boosts the immune response and enables your body to hunt down any remaining cells. Curious about the Braf and MEK inhibitors in this setting since the full blown disease often develops a workaround. It may be that with so much less disease to fight these drugs are more overpowering– I've also heard of trials with vaccines for adjuvant care (debatable results) I don't have a position on this– except I, like you, would be looking for an adjuvant trial and wanted to point out the recent data in case you missed it. Wishing you good luck
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- June 10, 2014 at 10:23 am
Hi Kenny,
I have not taken BRAFi or the combo myself…but the data is looking good for patients with disease, and as someone who participated in an NED arm of a trial myself, I think treating while with the least tumor burden is a good idea. Here are links to some additional background info if you are interested:
I wish you my best! Celeste
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- June 10, 2014 at 10:23 am
Hi Kenny,
I have not taken BRAFi or the combo myself…but the data is looking good for patients with disease, and as someone who participated in an NED arm of a trial myself, I think treating while with the least tumor burden is a good idea. Here are links to some additional background info if you are interested:
I wish you my best! Celeste
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- June 10, 2014 at 10:23 am
Hi Kenny,
I have not taken BRAFi or the combo myself…but the data is looking good for patients with disease, and as someone who participated in an NED arm of a trial myself, I think treating while with the least tumor burden is a good idea. Here are links to some additional background info if you are interested:
I wish you my best! Celeste
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- June 11, 2014 at 1:43 am
IMHO I personally would look for something else only because the control is no treatment whatsoever. Yeah I understand this is for stage III but still, only a 50:50 chance of getting a drug?
I would study some of the recent ASCO presentations and look for stage 3 that has some sort of control group that did have something other than placebo. Ipi + Braf vs. Ipi alone as adjuvent. I thought I saw something like that but it may have been for stage IV.
Also check if there is any crossover. With some of these new drugs, it becomes apparant very quickly that the new drug works better than the control so much so that cross over is allowed if you have recurrance.
Best of luck!
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- June 11, 2014 at 1:43 am
IMHO I personally would look for something else only because the control is no treatment whatsoever. Yeah I understand this is for stage III but still, only a 50:50 chance of getting a drug?
I would study some of the recent ASCO presentations and look for stage 3 that has some sort of control group that did have something other than placebo. Ipi + Braf vs. Ipi alone as adjuvent. I thought I saw something like that but it may have been for stage IV.
Also check if there is any crossover. With some of these new drugs, it becomes apparant very quickly that the new drug works better than the control so much so that cross over is allowed if you have recurrance.
Best of luck!
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- June 11, 2014 at 1:43 am
IMHO I personally would look for something else only because the control is no treatment whatsoever. Yeah I understand this is for stage III but still, only a 50:50 chance of getting a drug?
I would study some of the recent ASCO presentations and look for stage 3 that has some sort of control group that did have something other than placebo. Ipi + Braf vs. Ipi alone as adjuvent. I thought I saw something like that but it may have been for stage IV.
Also check if there is any crossover. With some of these new drugs, it becomes apparant very quickly that the new drug works better than the control so much so that cross over is allowed if you have recurrance.
Best of luck!
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- June 11, 2014 at 4:18 am
Kenny,
Here's a link to a thread on another site that has some info on stage IV adjuvant options. I'm sure some or most may not apply to stage III but you might get some useful info there.
You probably have seen the latest results from ASCO about the Ipi vs placebo trial in patients who were stage III resected. Essentially it showed that after 3 years 65% of the patients in the placebo arm had a recurrence. I think you are wise to try and fight this disease in the adjuvant setting if possible. I was in your shoes in 2011 and the only thing available to me was a Ipi vs. interferon trial. I was randomized into the interferon arm which was devasting at the time because I really was hoping for the ipi arm. I'm really not up to speed on what's available these days for stage III adjuvant treatments but you may want to try UVA in Charlottesville Va if you are anywhere near that location. They always seem to be working on a vaccine. You might also want to try the clinical finder service through MRF. They might be able to find you something.
Best of luck to you.
Brian
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- June 11, 2014 at 4:18 am
Kenny,
Here's a link to a thread on another site that has some info on stage IV adjuvant options. I'm sure some or most may not apply to stage III but you might get some useful info there.
You probably have seen the latest results from ASCO about the Ipi vs placebo trial in patients who were stage III resected. Essentially it showed that after 3 years 65% of the patients in the placebo arm had a recurrence. I think you are wise to try and fight this disease in the adjuvant setting if possible. I was in your shoes in 2011 and the only thing available to me was a Ipi vs. interferon trial. I was randomized into the interferon arm which was devasting at the time because I really was hoping for the ipi arm. I'm really not up to speed on what's available these days for stage III adjuvant treatments but you may want to try UVA in Charlottesville Va if you are anywhere near that location. They always seem to be working on a vaccine. You might also want to try the clinical finder service through MRF. They might be able to find you something.
Best of luck to you.
Brian
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- June 11, 2014 at 4:18 am
Kenny,
Here's a link to a thread on another site that has some info on stage IV adjuvant options. I'm sure some or most may not apply to stage III but you might get some useful info there.
You probably have seen the latest results from ASCO about the Ipi vs placebo trial in patients who were stage III resected. Essentially it showed that after 3 years 65% of the patients in the placebo arm had a recurrence. I think you are wise to try and fight this disease in the adjuvant setting if possible. I was in your shoes in 2011 and the only thing available to me was a Ipi vs. interferon trial. I was randomized into the interferon arm which was devasting at the time because I really was hoping for the ipi arm. I'm really not up to speed on what's available these days for stage III adjuvant treatments but you may want to try UVA in Charlottesville Va if you are anywhere near that location. They always seem to be working on a vaccine. You might also want to try the clinical finder service through MRF. They might be able to find you something.
Best of luck to you.
Brian
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- June 12, 2014 at 3:49 am
Thank you all for your responses, I live in Bend Or, and the closest place I can go for the trial is 160 miles away in Portland Or. That is OK with me after getting started I would only need to check in once a month for testing. I feel like I need to do more than just wait and the interferon treatment is not that appealing to me. I have read a lot and it is easy to get overloaded and end up with more questions than answers.
Thank you,
Ken
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- June 12, 2014 at 3:49 am
Thank you all for your responses, I live in Bend Or, and the closest place I can go for the trial is 160 miles away in Portland Or. That is OK with me after getting started I would only need to check in once a month for testing. I feel like I need to do more than just wait and the interferon treatment is not that appealing to me. I have read a lot and it is easy to get overloaded and end up with more questions than answers.
Thank you,
Ken
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- June 12, 2014 at 3:49 am
Thank you all for your responses, I live in Bend Or, and the closest place I can go for the trial is 160 miles away in Portland Or. That is OK with me after getting started I would only need to check in once a month for testing. I feel like I need to do more than just wait and the interferon treatment is not that appealing to me. I have read a lot and it is easy to get overloaded and end up with more questions than answers.
Thank you,
Ken
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- September 9, 2014 at 4:06 am
Kenny, did u end up going into this trial? I am in the mst-11. (Stage 3b, left upper back, 2 positive lymph nodes) I did biochemo/inferon for 3 rounds, Ned for just over 1 year. I have never heard of the braf mutation. I live in slc, utah.-
- September 9, 2014 at 11:55 am
Hi Melissa, I did not participate in the trial. It turned out I could not qualify due to not enough Melanoma tissue for the trial doctors to confirm that I am B-RAF positive. I was tested locally and it came back positive but they used up most of the tissue. In hind site I would have requested the tissue sent directly to the trial doctors for testing.
Take care, Ken
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- September 9, 2014 at 11:55 am
Hi Melissa, I did not participate in the trial. It turned out I could not qualify due to not enough Melanoma tissue for the trial doctors to confirm that I am B-RAF positive. I was tested locally and it came back positive but they used up most of the tissue. In hind site I would have requested the tissue sent directly to the trial doctors for testing.
Take care, Ken
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- September 9, 2014 at 11:55 am
Hi Melissa, I did not participate in the trial. It turned out I could not qualify due to not enough Melanoma tissue for the trial doctors to confirm that I am B-RAF positive. I was tested locally and it came back positive but they used up most of the tissue. In hind site I would have requested the tissue sent directly to the trial doctors for testing.
Take care, Ken
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- September 9, 2014 at 4:06 am
Kenny, did u end up going into this trial? I am in the mst-11. (Stage 3b, left upper back, 2 positive lymph nodes) I did biochemo/inferon for 3 rounds, Ned for just over 1 year. I have never heard of the braf mutation. I live in slc, utah. -
- September 9, 2014 at 4:06 am
Kenny, did u end up going into this trial? I am in the mst-11. (Stage 3b, left upper back, 2 positive lymph nodes) I did biochemo/inferon for 3 rounds, Ned for just over 1 year. I have never heard of the braf mutation. I live in slc, utah.
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