› Forums › General Melanoma Community › GlaxoSmithKline (GSK) BRAF/MEK Combo Trial for Stage III Patients
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jamfahey.
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- February 8, 2013 at 8:03 am
I have been in a GSK BRAF/MEK combo trial for Stage IV patients since May 2011. So far so good! John Patrick Michael Murphy, who also posts on this board, has been on this combo for over 2 years and recently posted that he is well.
GSK recently announced a study of this combo for Stage III patients:
I have been in a GSK BRAF/MEK combo trial for Stage IV patients since May 2011. So far so good! John Patrick Michael Murphy, who also posts on this board, has been on this combo for over 2 years and recently posted that he is well.
GSK recently announced a study of this combo for Stage III patients:
This will be a Phase III double blind study, with patients randomized to receive either the BRAF/MEK drug combo or placebos. It is something for completely resected Stage III patients to think about, as existing adjuvant therapy options are limited.
Best wishes,
Harry
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- February 8, 2013 at 11:39 pm
I’m curious what others think about this. Don’t these have a limited duration of effectiveness before they stop working? Is using up this effectiveness in an adjuvant setting a good idea? I have two weeks to make the interferon or active surveillance decision or could look at the trial option but I’m stage 3a and most trials that include stage 3 are not for 3a. I see that this one does include 3a, but would hate to lose the opportunity to use this if I were to progress to stage 4.Just curious what others think about this.
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- February 9, 2013 at 1:01 am
You are asking the right questions. This is a study to find out if this drug combo has any effectiveness in delaying or even stopping recurrence. It will take years to gather the info to determine this. So this may be a shot in the dark for someone in your situation. But I think it's an option – these are very limited for Stage III patients. Even if you get the placebos, your follow-up (such as scans) will probably be better.
When I was in your situation (Stage III in 1997) I chose a trial (a live melanoma vaccine – Cancervax). This treatment failed to live up to expectations when the Phase III results came in. But perhaps it helped me. I'll never know.
As for developing resistance, this combo of BRAF and MEK inhibitors may be a lot better than BRAF alone in Stage IV patients. That's the buzz I get. Perhaps, through research, much more sophisticated combos of tumor protein inhibitors (such as BRAF and MEK) and immunological agents will be developed. But that is what the clinical trial process is all about….
Best wishes,
Harry
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- February 9, 2013 at 1:01 am
You are asking the right questions. This is a study to find out if this drug combo has any effectiveness in delaying or even stopping recurrence. It will take years to gather the info to determine this. So this may be a shot in the dark for someone in your situation. But I think it's an option – these are very limited for Stage III patients. Even if you get the placebos, your follow-up (such as scans) will probably be better.
When I was in your situation (Stage III in 1997) I chose a trial (a live melanoma vaccine – Cancervax). This treatment failed to live up to expectations when the Phase III results came in. But perhaps it helped me. I'll never know.
As for developing resistance, this combo of BRAF and MEK inhibitors may be a lot better than BRAF alone in Stage IV patients. That's the buzz I get. Perhaps, through research, much more sophisticated combos of tumor protein inhibitors (such as BRAF and MEK) and immunological agents will be developed. But that is what the clinical trial process is all about….
Best wishes,
Harry
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- February 9, 2013 at 1:01 am
You are asking the right questions. This is a study to find out if this drug combo has any effectiveness in delaying or even stopping recurrence. It will take years to gather the info to determine this. So this may be a shot in the dark for someone in your situation. But I think it's an option – these are very limited for Stage III patients. Even if you get the placebos, your follow-up (such as scans) will probably be better.
When I was in your situation (Stage III in 1997) I chose a trial (a live melanoma vaccine – Cancervax). This treatment failed to live up to expectations when the Phase III results came in. But perhaps it helped me. I'll never know.
As for developing resistance, this combo of BRAF and MEK inhibitors may be a lot better than BRAF alone in Stage IV patients. That's the buzz I get. Perhaps, through research, much more sophisticated combos of tumor protein inhibitors (such as BRAF and MEK) and immunological agents will be developed. But that is what the clinical trial process is all about….
Best wishes,
Harry
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- February 10, 2013 at 1:24 am
If it were me and I had this trial opportunity over w/w or interferon, I would jump at it. interferon can have debilitating side-effects for many (affecting your quality of life for a year) and some onc’s do not prescribe it anymore. If you have any history of depression, it’s contra-indicated. I would do a search for it here and see the wide disparity of experiences.
I think Harry’s right–even on the placebo, you would get excellent follow-up, and if there is disease progression, hopefully you׳d be switched to the real meds. Also, at that time you’d likely be eligible for Yervoy, so you’d have options open to you. Hopefully anti-pd1 drugs will be approved in the not-too- distant future as well.
All the best,
Karen -
- February 10, 2013 at 1:24 am
If it were me and I had this trial opportunity over w/w or interferon, I would jump at it. interferon can have debilitating side-effects for many (affecting your quality of life for a year) and some onc’s do not prescribe it anymore. If you have any history of depression, it’s contra-indicated. I would do a search for it here and see the wide disparity of experiences.
I think Harry’s right–even on the placebo, you would get excellent follow-up, and if there is disease progression, hopefully you׳d be switched to the real meds. Also, at that time you’d likely be eligible for Yervoy, so you’d have options open to you. Hopefully anti-pd1 drugs will be approved in the not-too- distant future as well.
All the best,
Karen -
- February 10, 2013 at 1:24 am
If it were me and I had this trial opportunity over w/w or interferon, I would jump at it. interferon can have debilitating side-effects for many (affecting your quality of life for a year) and some onc’s do not prescribe it anymore. If you have any history of depression, it’s contra-indicated. I would do a search for it here and see the wide disparity of experiences.
I think Harry’s right–even on the placebo, you would get excellent follow-up, and if there is disease progression, hopefully you׳d be switched to the real meds. Also, at that time you’d likely be eligible for Yervoy, so you’d have options open to you. Hopefully anti-pd1 drugs will be approved in the not-too- distant future as well.
All the best,
Karen
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- February 8, 2013 at 11:39 pm
I’m curious what others think about this. Don’t these have a limited duration of effectiveness before they stop working? Is using up this effectiveness in an adjuvant setting a good idea? I have two weeks to make the interferon or active surveillance decision or could look at the trial option but I’m stage 3a and most trials that include stage 3 are not for 3a. I see that this one does include 3a, but would hate to lose the opportunity to use this if I were to progress to stage 4.Just curious what others think about this.
-
- February 8, 2013 at 11:39 pm
I’m curious what others think about this. Don’t these have a limited duration of effectiveness before they stop working? Is using up this effectiveness in an adjuvant setting a good idea? I have two weeks to make the interferon or active surveillance decision or could look at the trial option but I’m stage 3a and most trials that include stage 3 are not for 3a. I see that this one does include 3a, but would hate to lose the opportunity to use this if I were to progress to stage 4.Just curious what others think about this.
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- February 10, 2013 at 2:16 am
Harry is right. The durability of this combo remains under study as the data matures. I am in month 26 right now and feel grand and I am filled with gratitude. Harry knows his melanoma facts and I sure would give consideration to his opinions.I didn’t realize how fortunate I was for a while because I was concentrating on the power of my cancer, instead of the power of fact-based hope that surrounded me, protecting me, and going on the attack for me. Once I gained hope from the geniuses with their ideas and their molecules, never extant on Earth before now, I became an earnest participant, then a survivor and now a warrior.
As I see it the progression goes as follows: you get a bit of courage, and then hope, and then strength, mental and physical. Once you get it on the run, you look at yourself as a survivor, which is fine, but it is just a stage, and I don’t think one should spend too much time preening about it.
Lance is a survivor but so what. Did he carry gratitude with him as he pedaled so hard, so long.? How could a grateful person walk over others, and swear out a summons saying the truth was a lie? He
acted like he beat cancer, as if it could not return. He never became a warrior.I will never be caught sleeping again. It wants to kill me and it always will. I am on perpetual guard duty, but most of all I am grateful for what all this research has done for my cohorts and me. A warrior is grateful to remain on the battlefield, and vigilant lest the enemy try another assault.
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- February 10, 2013 at 2:16 am
Harry is right. The durability of this combo remains under study as the data matures. I am in month 26 right now and feel grand and I am filled with gratitude. Harry knows his melanoma facts and I sure would give consideration to his opinions.I didn’t realize how fortunate I was for a while because I was concentrating on the power of my cancer, instead of the power of fact-based hope that surrounded me, protecting me, and going on the attack for me. Once I gained hope from the geniuses with their ideas and their molecules, never extant on Earth before now, I became an earnest participant, then a survivor and now a warrior.
As I see it the progression goes as follows: you get a bit of courage, and then hope, and then strength, mental and physical. Once you get it on the run, you look at yourself as a survivor, which is fine, but it is just a stage, and I don’t think one should spend too much time preening about it.
Lance is a survivor but so what. Did he carry gratitude with him as he pedaled so hard, so long.? How could a grateful person walk over others, and swear out a summons saying the truth was a lie? He
acted like he beat cancer, as if it could not return. He never became a warrior.I will never be caught sleeping again. It wants to kill me and it always will. I am on perpetual guard duty, but most of all I am grateful for what all this research has done for my cohorts and me. A warrior is grateful to remain on the battlefield, and vigilant lest the enemy try another assault.
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- February 10, 2013 at 1:09 pm
Thanks NY Karen, I should have said that Harry and Karen know their facts. Of all the fourth staggers in here, I have paid the least dues. I was Stage IV on discovery, while many of my cohorts have been battling for most of a decade as they went from nevi to stage IV. I have tried no other treatments, other than the combo, that I call Smith and Wesson, barring the 15 jolts of radiation to my ilium where it nested as it sent out a troupe to invade my lungs. I didn’t go to school, but I talked with the scholars (like Karen and Harry) on their way home. I am grateful to all of you here. -
- February 10, 2013 at 1:09 pm
Thanks NY Karen, I should have said that Harry and Karen know their facts. Of all the fourth staggers in here, I have paid the least dues. I was Stage IV on discovery, while many of my cohorts have been battling for most of a decade as they went from nevi to stage IV. I have tried no other treatments, other than the combo, that I call Smith and Wesson, barring the 15 jolts of radiation to my ilium where it nested as it sent out a troupe to invade my lungs. I didn’t go to school, but I talked with the scholars (like Karen and Harry) on their way home. I am grateful to all of you here. -
- February 10, 2013 at 1:09 pm
Thanks NY Karen, I should have said that Harry and Karen know their facts. Of all the fourth staggers in here, I have paid the least dues. I was Stage IV on discovery, while many of my cohorts have been battling for most of a decade as they went from nevi to stage IV. I have tried no other treatments, other than the combo, that I call Smith and Wesson, barring the 15 jolts of radiation to my ilium where it nested as it sent out a troupe to invade my lungs. I didn’t go to school, but I talked with the scholars (like Karen and Harry) on their way home. I am grateful to all of you here.
-
- February 10, 2013 at 2:16 am
Harry is right. The durability of this combo remains under study as the data matures. I am in month 26 right now and feel grand and I am filled with gratitude. Harry knows his melanoma facts and I sure would give consideration to his opinions.I didn’t realize how fortunate I was for a while because I was concentrating on the power of my cancer, instead of the power of fact-based hope that surrounded me, protecting me, and going on the attack for me. Once I gained hope from the geniuses with their ideas and their molecules, never extant on Earth before now, I became an earnest participant, then a survivor and now a warrior.
As I see it the progression goes as follows: you get a bit of courage, and then hope, and then strength, mental and physical. Once you get it on the run, you look at yourself as a survivor, which is fine, but it is just a stage, and I don’t think one should spend too much time preening about it.
Lance is a survivor but so what. Did he carry gratitude with him as he pedaled so hard, so long.? How could a grateful person walk over others, and swear out a summons saying the truth was a lie? He
acted like he beat cancer, as if it could not return. He never became a warrior.I will never be caught sleeping again. It wants to kill me and it always will. I am on perpetual guard duty, but most of all I am grateful for what all this research has done for my cohorts and me. A warrior is grateful to remain on the battlefield, and vigilant lest the enemy try another assault.
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- February 10, 2013 at 9:55 pm
What is BRAF/MEK? I'm still new to this site (husband diagnosed Stage IV just a month ago, with no history of any melanoma anywhere before this). I know he tested positive for the BRAF mutation (well, nearly, as the insurance company is saying his positive isn't close enough for coverage), and we were hoping his first treatment would be Zelboraf. So I want to learn as much as I can about alternative treatments.
Thanks. You are all such awesome warriors.
Janet
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- February 10, 2013 at 9:55 pm
What is BRAF/MEK? I'm still new to this site (husband diagnosed Stage IV just a month ago, with no history of any melanoma anywhere before this). I know he tested positive for the BRAF mutation (well, nearly, as the insurance company is saying his positive isn't close enough for coverage), and we were hoping his first treatment would be Zelboraf. So I want to learn as much as I can about alternative treatments.
Thanks. You are all such awesome warriors.
Janet
-
- February 10, 2013 at 9:55 pm
What is BRAF/MEK? I'm still new to this site (husband diagnosed Stage IV just a month ago, with no history of any melanoma anywhere before this). I know he tested positive for the BRAF mutation (well, nearly, as the insurance company is saying his positive isn't close enough for coverage), and we were hoping his first treatment would be Zelboraf. So I want to learn as much as I can about alternative treatments.
Thanks. You are all such awesome warriors.
Janet
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- February 10, 2013 at 10:45 pm
Hi Janet,
I want you to call the State Insurance Commissioner about your husband’s coverage and the press and just generally raise hell. If he is BRAF positive he is entitled to a BRAf inhibitor. Tell them is it already FDA approved.for stage IV. Tell them to get ready for another inhibitor called MEK to be licensed soon, and they better take care of him when it is available. Then look for attorneys who specialize in suing insurance companies for bad faith dealing with their customers who can clean their clocks with facts like these. But before you do these things tell the insurance people that you have been advised by an old trial lawyer, now retired, who is on active status as a cancer warrior, that you should do all these things, Then ask the insurance people what they think of such an opinion. That’s how I used to put the twist on them, and most of my clients didn’t need the bad faith case.As to the rest, as I see it our DNA is a huge twisted ladder with different genes sitting on the rungs.These genes make proteins which make us, us. One called BRAF has gone berserk making too many proteins that do not die, and this is cancer…a switch stuck on. That can be inhibited by a drug if one has the right genome. He needs it now and needs a script and the genome test results. This extends his life, but cancer is treacherous, and tries another rung and quite often it is the one called MEK, and makes it go berserk, and the combo will keep him alive longer than just the BRAF alone. The last is an assertion but it is based on my observations as a cohort to the phase one part of the trial. The MEK inhibitor makes the benefits of BRAF inhibitor even stronger, whilst mollifying the adverse affects. Truly a match made in heaven for us.
I, as a retired lawyer, am on inactive status, and can no longer render legal opinions, but no rule profits anyone from having opinions on the law.
jpm2
Colorado Atty. Registration Number 292 -
- February 10, 2013 at 10:45 pm
Hi Janet,
I want you to call the State Insurance Commissioner about your husband’s coverage and the press and just generally raise hell. If he is BRAF positive he is entitled to a BRAf inhibitor. Tell them is it already FDA approved.for stage IV. Tell them to get ready for another inhibitor called MEK to be licensed soon, and they better take care of him when it is available. Then look for attorneys who specialize in suing insurance companies for bad faith dealing with their customers who can clean their clocks with facts like these. But before you do these things tell the insurance people that you have been advised by an old trial lawyer, now retired, who is on active status as a cancer warrior, that you should do all these things, Then ask the insurance people what they think of such an opinion. That’s how I used to put the twist on them, and most of my clients didn’t need the bad faith case.As to the rest, as I see it our DNA is a huge twisted ladder with different genes sitting on the rungs.These genes make proteins which make us, us. One called BRAF has gone berserk making too many proteins that do not die, and this is cancer…a switch stuck on. That can be inhibited by a drug if one has the right genome. He needs it now and needs a script and the genome test results. This extends his life, but cancer is treacherous, and tries another rung and quite often it is the one called MEK, and makes it go berserk, and the combo will keep him alive longer than just the BRAF alone. The last is an assertion but it is based on my observations as a cohort to the phase one part of the trial. The MEK inhibitor makes the benefits of BRAF inhibitor even stronger, whilst mollifying the adverse affects. Truly a match made in heaven for us.
I, as a retired lawyer, am on inactive status, and can no longer render legal opinions, but no rule profits anyone from having opinions on the law.
jpm2
Colorado Atty. Registration Number 292 -
- February 10, 2013 at 11:02 pm
John, thanks for such an animated and knowledgeable reply. I am hoping the info that Dana Farber sent to the insurance company (actually, CVS/Caremark,, the "pharmacy benefits manager" for Blue Cross/Blue Shield) will work and he'll be approved. It's not bad enough that we are fighting for the life of a wonderful man, now we have to fight big insurance!
I wonder if anyone has any idea how much personal damage and death has been caused by insurance companies through their bureaucratic delays?
Janet
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- February 10, 2013 at 11:02 pm
John, thanks for such an animated and knowledgeable reply. I am hoping the info that Dana Farber sent to the insurance company (actually, CVS/Caremark,, the "pharmacy benefits manager" for Blue Cross/Blue Shield) will work and he'll be approved. It's not bad enough that we are fighting for the life of a wonderful man, now we have to fight big insurance!
I wonder if anyone has any idea how much personal damage and death has been caused by insurance companies through their bureaucratic delays?
Janet
-
- February 10, 2013 at 11:02 pm
John, thanks for such an animated and knowledgeable reply. I am hoping the info that Dana Farber sent to the insurance company (actually, CVS/Caremark,, the "pharmacy benefits manager" for Blue Cross/Blue Shield) will work and he'll be approved. It's not bad enough that we are fighting for the life of a wonderful man, now we have to fight big insurance!
I wonder if anyone has any idea how much personal damage and death has been caused by insurance companies through their bureaucratic delays?
Janet
-
- February 10, 2013 at 10:45 pm
Hi Janet,
I want you to call the State Insurance Commissioner about your husband’s coverage and the press and just generally raise hell. If he is BRAF positive he is entitled to a BRAf inhibitor. Tell them is it already FDA approved.for stage IV. Tell them to get ready for another inhibitor called MEK to be licensed soon, and they better take care of him when it is available. Then look for attorneys who specialize in suing insurance companies for bad faith dealing with their customers who can clean their clocks with facts like these. But before you do these things tell the insurance people that you have been advised by an old trial lawyer, now retired, who is on active status as a cancer warrior, that you should do all these things, Then ask the insurance people what they think of such an opinion. That’s how I used to put the twist on them, and most of my clients didn’t need the bad faith case.As to the rest, as I see it our DNA is a huge twisted ladder with different genes sitting on the rungs.These genes make proteins which make us, us. One called BRAF has gone berserk making too many proteins that do not die, and this is cancer…a switch stuck on. That can be inhibited by a drug if one has the right genome. He needs it now and needs a script and the genome test results. This extends his life, but cancer is treacherous, and tries another rung and quite often it is the one called MEK, and makes it go berserk, and the combo will keep him alive longer than just the BRAF alone. The last is an assertion but it is based on my observations as a cohort to the phase one part of the trial. The MEK inhibitor makes the benefits of BRAF inhibitor even stronger, whilst mollifying the adverse affects. Truly a match made in heaven for us.
I, as a retired lawyer, am on inactive status, and can no longer render legal opinions, but no rule profits anyone from having opinions on the law.
jpm2
Colorado Atty. Registration Number 292
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- February 12, 2013 at 12:12 am
Harry, Karen and JPMM Thank you so much for your input. I have pretty much ruled out the interferon option. When I meet with my oncologist, I’ll talk to him about this trial. Do any of you know, will they do the BRAF testing as part of the trial? or should I have my oncologist have that done? The idea of having such thorough follow up is a benefit I had not thought of. It doesn’t even list locations for this trial yet and they aren’t recruiting yet so I’ll see if it starts in time.Thanks again for all of your input.
Thandster
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- February 12, 2013 at 12:12 am
Harry, Karen and JPMM Thank you so much for your input. I have pretty much ruled out the interferon option. When I meet with my oncologist, I’ll talk to him about this trial. Do any of you know, will they do the BRAF testing as part of the trial? or should I have my oncologist have that done? The idea of having such thorough follow up is a benefit I had not thought of. It doesn’t even list locations for this trial yet and they aren’t recruiting yet so I’ll see if it starts in time.Thanks again for all of your input.
Thandster
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- February 12, 2013 at 3:35 pm
You will need to get a hold of GSK to find out the mechanics of getting approved BRAF testing. They will probably refer you to a participating clinic. In my case, they had my HMO forward tumor samples to their approved lab, which did the testing. I had to pay for the lab testing – I don't remmember the exact amount but I think it was in the $400-600 range.
Best wishes,
Harry
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- February 12, 2013 at 3:35 pm
You will need to get a hold of GSK to find out the mechanics of getting approved BRAF testing. They will probably refer you to a participating clinic. In my case, they had my HMO forward tumor samples to their approved lab, which did the testing. I had to pay for the lab testing – I don't remmember the exact amount but I think it was in the $400-600 range.
Best wishes,
Harry
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- March 4, 2013 at 3:46 am
I am a cohort with John on the GSK BRAF/MEK trial at MGH. I just celebrated my 2 yr anniversary (Feb 22) and like John, one small sliver left in my lung (79% shrunk). Only the best radialogist (with a great pair of glasses) can see anything, but no NED badge yet (but close). I m a big fan of the combo, and GSK!! This site is great. Hope is eternal,
Jim
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- March 4, 2013 at 3:46 am
I am a cohort with John on the GSK BRAF/MEK trial at MGH. I just celebrated my 2 yr anniversary (Feb 22) and like John, one small sliver left in my lung (79% shrunk). Only the best radialogist (with a great pair of glasses) can see anything, but no NED badge yet (but close). I m a big fan of the combo, and GSK!! This site is great. Hope is eternal,
Jim
-
- March 4, 2013 at 3:46 am
I am a cohort with John on the GSK BRAF/MEK trial at MGH. I just celebrated my 2 yr anniversary (Feb 22) and like John, one small sliver left in my lung (79% shrunk). Only the best radialogist (with a great pair of glasses) can see anything, but no NED badge yet (but close). I m a big fan of the combo, and GSK!! This site is great. Hope is eternal,
Jim
-
- February 12, 2013 at 3:35 pm
You will need to get a hold of GSK to find out the mechanics of getting approved BRAF testing. They will probably refer you to a participating clinic. In my case, they had my HMO forward tumor samples to their approved lab, which did the testing. I had to pay for the lab testing – I don't remmember the exact amount but I think it was in the $400-600 range.
Best wishes,
Harry
-
- February 12, 2013 at 12:12 am
Harry, Karen and JPMM Thank you so much for your input. I have pretty much ruled out the interferon option. When I meet with my oncologist, I’ll talk to him about this trial. Do any of you know, will they do the BRAF testing as part of the trial? or should I have my oncologist have that done? The idea of having such thorough follow up is a benefit I had not thought of. It doesn’t even list locations for this trial yet and they aren’t recruiting yet so I’ll see if it starts in time.Thanks again for all of your input.
Thandster
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