Stage 3B Ipi studies for resected tumors?

Best of luck to you too!  I know what a difficult decision this is!

Best of luck to you too!  I know what a difficult decision this is!

Best of luck to you too!  I know what a difficult decision this is!

Et-SF, just curious where to find back ground information on Pol-103a , I can't find any phase 1 or 2 data. Thanks Ed

Hi Ed,

Go to the polynoma.com website, and click on the "publications" tab.  You'll find most of the primary literature there.  Some is pay-per-download, and some is public access.

I consider these among the most important papers:

   http://clincancerres.aacrjournals.org/content/9/4/1497

   http://onlinelibrary.wiley.com/doi/10.1002/ijc.21820/pdf

   http://clincancerres.aacrjournals.org/content/7/7/1882.full.pdf

Please note that the POL-103a vaccine was originally called "a polyvalent melanoma antigen vaccine."  Then it was called POL-103a.  Most recently, it has been named seviprotimut-L.  Hope that helps.

Hi Ed,

Go to the polynoma.com website, and click on the "publications" tab.  You'll find most of the primary literature there.  Some is pay-per-download, and some is public access.

I consider these among the most important papers:

   http://clincancerres.aacrjournals.org/content/9/4/1497

   http://onlinelibrary.wiley.com/doi/10.1002/ijc.21820/pdf

   http://clincancerres.aacrjournals.org/content/7/7/1882.full.pdf

Please note that the POL-103a vaccine was originally called "a polyvalent melanoma antigen vaccine."  Then it was called POL-103a.  Most recently, it has been named seviprotimut-L.  Hope that helps.

Hi Ed,

Go to the polynoma.com website, and click on the "publications" tab.  You'll find most of the primary literature there.  Some is pay-per-download, and some is public access.

I consider these among the most important papers:

   http://clincancerres.aacrjournals.org/content/9/4/1497

   http://onlinelibrary.wiley.com/doi/10.1002/ijc.21820/pdf

   http://clincancerres.aacrjournals.org/content/7/7/1882.full.pdf

Please note that the POL-103a vaccine was originally called "a polyvalent melanoma antigen vaccine."  Then it was called POL-103a.  Most recently, it has been named seviprotimut-L.  Hope that helps.

Et-SF, just curious where to find back ground information on Pol-103a , I can't find any phase 1 or 2 data. Thanks Ed

Et-SF, just curious where to find back ground information on Pol-103a , I can't find any phase 1 or 2 data. Thanks Ed

Actually, ETSF…there IS data with immunotherapy and NED/adjuvant treatment.  Just happen to be a rattie in that world myself.  Be careful the "data" you impart!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  Vaccines have yet to be effective in melanoma.  I think they will be eventually….but right now….big question mark.  Everyone must decide what is best for them…but some of us are doing very well "killing off stray melanoma cells" …in our "kettle of fish".  Some of us are here actually doing it….not reading about it for others.  Thank goodness I had a "Sherman Tank" for my NED Stage IV melanoma.  I am now 5 years NED after Nivolumab, NED arm.  Melanoma patient since 2003. With a 70% plus response rate in my NED arm, I think that shows "benefit"….don't you?  I hope that helps!  Celeste

Actually, ETSF…there IS data with immunotherapy and NED/adjuvant treatment.  Just happen to be a rattie in that world myself.  Be careful the "data" you impart!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  Vaccines have yet to be effective in melanoma.  I think they will be eventually….but right now….big question mark.  Everyone must decide what is best for them…but some of us are doing very well "killing off stray melanoma cells" …in our "kettle of fish".  Some of us are here actually doing it….not reading about it for others.  Thank goodness I had a "Sherman Tank" for my NED Stage IV melanoma.  I am now 5 years NED after Nivolumab, NED arm.  Melanoma patient since 2003. With a 70% plus response rate in my NED arm, I think that shows "benefit"….don't you?  I hope that helps!  Celeste

In case you'd like to read the data for yourself:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

In case you'd like to read the data for yourself:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

I think we're all in this together.  Are we not?

The study you participated in is promising, to be sure.  However, it is not a controlled study, and the sample sizes are small.  (Small sample sizes are a concern I also have about the double-blind vaccine study, but I am still persuaded by the statistical findings.)  Although this study would have been helpful in our decision making, it is still not quite what we were looking for.

I also realize vaccine treatments are unpopular and greeted with considerable skepticism.  However, as a scientist, I don't really care about popular opinions.  I believe the results are what they are.  I find the investigators' systematic approach to the evaluation of this drug to be of an unusually high scientific caliber.  There are many approaches to vaccination, and not all vaccines are the same.  Few would argue T-VEC is ineffective, for instance, and yet it is a novel vaccine.  The polyvalent expression of the seviprotimut-L addresses (and hopefully solves) a problem common to many vaccines that have failed — that of the ability of the tumor to mutate around attack against limited numbers of antigens.

I think we're all in this together.  Are we not?

The study you participated in is promising, to be sure.  However, it is not a controlled study, and the sample sizes are small.  (Small sample sizes are a concern I also have about the double-blind vaccine study, but I am still persuaded by the statistical findings.)  Although this study would have been helpful in our decision making, it is still not quite what we were looking for.

I also realize vaccine treatments are unpopular and greeted with considerable skepticism.  However, as a scientist, I don't really care about popular opinions.  I believe the results are what they are.  I find the investigators' systematic approach to the evaluation of this drug to be of an unusually high scientific caliber.  There are many approaches to vaccination, and not all vaccines are the same.  Few would argue T-VEC is ineffective, for instance, and yet it is a novel vaccine.  The polyvalent expression of the seviprotimut-L addresses (and hopefully solves) a problem common to many vaccines that have failed — that of the ability of the tumor to mutate around attack against limited numbers of antigens.

Well, ET-SF:  What sort of scientist are you exactly?  Not controlled?  Vaccines are unpopular?  Hmmmm….  If you bothered to read my study you would have seen it actually provided you with more data about a vaccine.  My study was a combo of nivolizumab/opdivo and 6 peptide vaccines.  We ratties, with our small, lame, uncontrolled numbers…some of us now dead…you're welcome….provided the needed info that IT DID NOT WORK!!!  Nivo did, but the peptide vaccine did not.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/05/peptide-vaccines-do-not-trigger.html

Here is the only and latest vaccine that is making any kind of head way in melanoma currently:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/08/positive-response-to-helper-peptide.html

I am a huge believer in T-vec as well as other intralesional therapies and think that they will hold a key to at least some positive results for some melanoma patients.  And while, T-vec, when injected intralesionally, causes the lysis of melanoma cells and release of tumor antigens and facilitates their processing by GM-CSF, it is not an exogenously formulated vaccine.  A scientist would understand that your characterization of it as a 'typical vaccine" would be a bit disingenuious wouldn't it?

As a 'scientist' you are comfortable with this statement????!!!!  "Little or nothing seems to be known about the effectiveness of a PD-1 blockade drug in promoting immune attacks against isolated melanoma cells and microscopic cell clusters.  Although pembrolizumab would likely up-regulate immune responses in other ways, its principal benefit of helping CD8+ T cells to retain their efficacy in hostile tumor microenvironments would not be realized (i.e. in the absence of a tumor).  As such, it may be no more effective than interferon in this application." 

Well, all I can say to that is WOW!!!!  You have entered melanoma world and know more about anti-PD1 and immunotherapy in melanoma than Ribas, Weber, Hodi, Agarwala, and all the melanoma big dogs.  That is impressive.  I mean, they have been working on this stuff for years and seem to feel they actually do understand a great deal about how anti-PD1 works to kill those "isolated melanoma cells and microscopic cell clusters".  And….uhhh yeah…those goof asses DO think it is much more effective than interferon!  But, what do they know??

Maybe you're just expounding on a "hunch"?  Folks on this site depend on what is posted here to be based in real experience or in real data.  The articles you provided Ed are from 2002, 2006, and 2001!  The first two papers provide NO data regarding outcomes.  The third paper utilized 24 patients in the treatment group and 14 in placebo.  And you're critical of small sample size?  And the outcome?  Drum roll please…….  NO STATISTICAL DIFFERENCE.  This is what impresses you????  Thank goodness, we've come a long way since then!!   Check out what some of the experts in current immunotherapy have to say.  Take your pick: 

This one has a neat slide to tell you a little more about immunotherapy and what melanoma big dogs DO know about the action of anti-PD1:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/pick-your-poison-weber-and-agarwala.html

Here is a chat between Ribas and Weber, where, among other things, ipi as adjuvant is discussed:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/pretty-darn-impressivea-chat-between.html

Like science?  Here's a post that should interest you.  It includes data from 2015 on:  Adjuvant ipilimumab vs placebo after complete resection of high-risk stage III melanoma:  a randomized, double-blind, phase 3 trial. in which it was determined that "Adjuvant ipi significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma."  Here's the link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

I am very sorry for what you and your friend are going through.  Having someone in your corner to help figure things out when you are the patient is wonderful.  However, your stressed situation doesn't obviate the need for you to think about who is reading what you have to say. Being dismissive of those who went before and putting out opinion as fact is not ok.  And, finally, if you bother to read the data I have presented you will find that my OPINION, quite CONTRARY to your PRONOUNCEMENT, about the unpopularity of vaccines (and flying in the face of one who took six incredibly painful IM vaccine injections every 2 weeks for 6 months!!!!!!!!!!!!!!!….along with my 33 other meager, uncontrolled ratties!!!!) was this:  "I still hold out hope that vaccines will be the answer to at least some, if not all, of the curing melanoma equation!!!"

We all have to choose the path we think is best for us.  Picking your poison in melanoma is an unclear crap shoot at best.  I hope the vaccine trial you have selected provides a wonderful response for your partner and many others. However, it is very clear that there is, in fact, a great deal of data that shows many current therapies DO hold promise as adjuvant treatment for melanoma as well.  celeste

Ya know… I'm not a Christian, but I think that Jesus guy was pretty smart about at least one thing:  Turn the other cheek!  Just don't engage with this sort of stuff.  So let's start over, shall we?  Here's my attempt to meet palpable hostility with civility:

What sort of a scientist am I?  I'm a comparative sensory physiologist.  (Yes, I have a Ph.D. and peer-reviewed publications, taught some, did research, retired too early.)  I am not an immunologist.  If you had to draw a big circle around my weakest area of understanding in the biological sciences, it would probably be molecular biology in general, with the exception of the pharmacodynamics of certain psychoactive medications, and even there, my knowledge is dated.  Does my background help me to understand melanoma or its treatment?  Only somewhat.  Scientists do mostly speak the same language, often with different accents deriving from differing cultures.  So trust me that this has been a huge learning curve, piled on top of raw emotions and fighting the daily battles of treatment and mobilization for our war against melanoma, not to mention the usual daily trials such as beating back hurricane flood waters. 

Have I learned all there is to know so far?  No.  And neither have you, judging from comments you have made here.  We could both benefit from civil discussion — sharing what we know.  You might have more to share.  You've been in this game longer than we.

What I can't do is to fight with people.  I can't deal with people who misread and misinterpret what I write, spin their misinterpretations in the most negative possible context, and then, and attack me like a pit bull.  Melanoma is already a horrible enough enemy; I don't need another.  I'm physically and emotionally exhausted.  I came here to learn and to share.  This has to be an active process for me.  There are ways for us to engage in constructive dialog, and we might both benefit (yes, even you).  However, I can't take the sort of savaging I just experienced from you.  Not now.

So please be respectful.  Do not dismiss my role in all of this in the same way as you seem to feel (incorrectly) that I've dismissed the past contributions of experimental treatment volunteers like my ET. (I really dislike the expression "ratties.")  And also please do not dismiss our relationship as just a friendship.  Perhaps we can proceed forward with mutual trust and respect?

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

Dear SF      Yes, indeed lets start over. I was inclined to give you the benefit of the doubt because I empathized with your circumstances. Now it is apparent that your restart is only a restatement in more strident terms of your dogmatic and actually uninformed (read me correctly "wrong") opinions about the science.That by itself is counterproductive to the process of learning and sharing that we strive for here. More than that you are disdainful of those who have suffered and sometimes died to provide others with the data which you misunderstand and misquote. As I said, melanoma world is a harsh place: you can only survive with the help of ratties and the occasional pit bull at your side. Long live the ratties.

                                                                                                             Brent Morris MD FAAP MA

I am glad to see a "Non-Christian" does have some "Christian" values and I hope down your road you may even come to see the wonder life a believer can have. 

We are all in this together "believers and non-believers". All help that can be offered to others are a benefit that that does include opinions. Let's also hope that everyone does their own research and makes their own choices on what they feel comfortable in.  I am a scientist as well and the one thing I know is Melanoma kills and we all have to do what we can to fight it. Praying also helps and support from our friends, family and neighbors are a must. 

Tom

I am glad to see a "Non-Christian" does have some "Christian" values and I hope down your road you may even come to see the wonder life a believer can have. 

We are all in this together "believers and non-believers". All help that can be offered to others are a benefit that that does include opinions. Let's also hope that everyone does their own research and makes their own choices on what they feel comfortable in.  I am a scientist as well and the one thing I know is Melanoma kills and we all have to do what we can to fight it. Praying also helps and support from our friends, family and neighbors are a must. 

Tom

I am glad to see a "Non-Christian" does have some "Christian" values and I hope down your road you may even come to see the wonder life a believer can have. 

We are all in this together "believers and non-believers". All help that can be offered to others are a benefit that that does include opinions. Let's also hope that everyone does their own research and makes their own choices on what they feel comfortable in.  I am a scientist as well and the one thing I know is Melanoma kills and we all have to do what we can to fight it. Praying also helps and support from our friends, family and neighbors are a must. 

Tom

Ya know… I'm not a Christian, but I think that Jesus guy was pretty smart about at least one thing:  Turn the other cheek!  Just don't engage with this sort of stuff.  So let's start over, shall we?  Here's my attempt to meet palpable hostility with civility:

What sort of a scientist am I?  I'm a comparative sensory physiologist.  (Yes, I have a Ph.D. and peer-reviewed publications, taught some, did research, retired too early.)  I am not an immunologist.  If you had to draw a big circle around my weakest area of understanding in the biological sciences, it would probably be molecular biology in general, with the exception of the pharmacodynamics of certain psychoactive medications, and even there, my knowledge is dated.  Does my background help me to understand melanoma or its treatment?  Only somewhat.  Scientists do mostly speak the same language, often with different accents deriving from differing cultures.  So trust me that this has been a huge learning curve, piled on top of raw emotions and fighting the daily battles of treatment and mobilization for our war against melanoma, not to mention the usual daily trials such as beating back hurricane flood waters. 

Have I learned all there is to know so far?  No.  And neither have you, judging from comments you have made here.  We could both benefit from civil discussion — sharing what we know.  You might have more to share.  You've been in this game longer than we.

What I can't do is to fight with people.  I can't deal with people who misread and misinterpret what I write, spin their misinterpretations in the most negative possible context, and then, and attack me like a pit bull.  Melanoma is already a horrible enough enemy; I don't need another.  I'm physically and emotionally exhausted.  I came here to learn and to share.  This has to be an active process for me.  There are ways for us to engage in constructive dialog, and we might both benefit (yes, even you).  However, I can't take the sort of savaging I just experienced from you.  Not now.

So please be respectful.  Do not dismiss my role in all of this in the same way as you seem to feel (incorrectly) that I've dismissed the past contributions of experimental treatment volunteers like my ET. (I really dislike the expression "ratties.")  And also please do not dismiss our relationship as just a friendship.  Perhaps we can proceed forward with mutual trust and respect?

Ya know… I'm not a Christian, but I think that Jesus guy was pretty smart about at least one thing:  Turn the other cheek!  Just don't engage with this sort of stuff.  So let's start over, shall we?  Here's my attempt to meet palpable hostility with civility:

What sort of a scientist am I?  I'm a comparative sensory physiologist.  (Yes, I have a Ph.D. and peer-reviewed publications, taught some, did research, retired too early.)  I am not an immunologist.  If you had to draw a big circle around my weakest area of understanding in the biological sciences, it would probably be molecular biology in general, with the exception of the pharmacodynamics of certain psychoactive medications, and even there, my knowledge is dated.  Does my background help me to understand melanoma or its treatment?  Only somewhat.  Scientists do mostly speak the same language, often with different accents deriving from differing cultures.  So trust me that this has been a huge learning curve, piled on top of raw emotions and fighting the daily battles of treatment and mobilization for our war against melanoma, not to mention the usual daily trials such as beating back hurricane flood waters. 

Have I learned all there is to know so far?  No.  And neither have you, judging from comments you have made here.  We could both benefit from civil discussion — sharing what we know.  You might have more to share.  You've been in this game longer than we.

What I can't do is to fight with people.  I can't deal with people who misread and misinterpret what I write, spin their misinterpretations in the most negative possible context, and then, and attack me like a pit bull.  Melanoma is already a horrible enough enemy; I don't need another.  I'm physically and emotionally exhausted.  I came here to learn and to share.  This has to be an active process for me.  There are ways for us to engage in constructive dialog, and we might both benefit (yes, even you).  However, I can't take the sort of savaging I just experienced from you.  Not now.

So please be respectful.  Do not dismiss my role in all of this in the same way as you seem to feel (incorrectly) that I've dismissed the past contributions of experimental treatment volunteers like my ET. (I really dislike the expression "ratties.")  And also please do not dismiss our relationship as just a friendship.  Perhaps we can proceed forward with mutual trust and respect?

Well, ET-SF:  What sort of scientist are you exactly?  Not controlled?  Vaccines are unpopular?  Hmmmm….  If you bothered to read my study you would have seen it actually provided you with more data about a vaccine.  My study was a combo of nivolizumab/opdivo and 6 peptide vaccines.  We ratties, with our small, lame, uncontrolled numbers…some of us now dead…you're welcome….provided the needed info that IT DID NOT WORK!!!  Nivo did, but the peptide vaccine did not.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/05/peptide-vaccines-do-not-trigger.html

Here is the only and latest vaccine that is making any kind of head way in melanoma currently:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/08/positive-response-to-helper-peptide.html

I am a huge believer in T-vec as well as other intralesional therapies and think that they will hold a key to at least some positive results for some melanoma patients.  And while, T-vec, when injected intralesionally, causes the lysis of melanoma cells and release of tumor antigens and facilitates their processing by GM-CSF, it is not an exogenously formulated vaccine.  A scientist would understand that your characterization of it as a 'typical vaccine" would be a bit disingenuious wouldn't it?

As a 'scientist' you are comfortable with this statement????!!!!  "Little or nothing seems to be known about the effectiveness of a PD-1 blockade drug in promoting immune attacks against isolated melanoma cells and microscopic cell clusters.  Although pembrolizumab would likely up-regulate immune responses in other ways, its principal benefit of helping CD8+ T cells to retain their efficacy in hostile tumor microenvironments would not be realized (i.e. in the absence of a tumor).  As such, it may be no more effective than interferon in this application." 

Well, all I can say to that is WOW!!!!  You have entered melanoma world and know more about anti-PD1 and immunotherapy in melanoma than Ribas, Weber, Hodi, Agarwala, and all the melanoma big dogs.  That is impressive.  I mean, they have been working on this stuff for years and seem to feel they actually do understand a great deal about how anti-PD1 works to kill those "isolated melanoma cells and microscopic cell clusters".  And….uhhh yeah…those goof asses DO think it is much more effective than interferon!  But, what do they know??

Maybe you're just expounding on a "hunch"?  Folks on this site depend on what is posted here to be based in real experience or in real data.  The articles you provided Ed are from 2002, 2006, and 2001!  The first two papers provide NO data regarding outcomes.  The third paper utilized 24 patients in the treatment group and 14 in placebo.  And you're critical of small sample size?  And the outcome?  Drum roll please…….  NO STATISTICAL DIFFERENCE.  This is what impresses you????  Thank goodness, we've come a long way since then!!   Check out what some of the experts in current immunotherapy have to say.  Take your pick: 

This one has a neat slide to tell you a little more about immunotherapy and what melanoma big dogs DO know about the action of anti-PD1:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/pick-your-poison-weber-and-agarwala.html

Here is a chat between Ribas and Weber, where, among other things, ipi as adjuvant is discussed:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/pretty-darn-impressivea-chat-between.html

Like science?  Here's a post that should interest you.  It includes data from 2015 on:  Adjuvant ipilimumab vs placebo after complete resection of high-risk stage III melanoma:  a randomized, double-blind, phase 3 trial. in which it was determined that "Adjuvant ipi significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma."  Here's the link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

I am very sorry for what you and your friend are going through.  Having someone in your corner to help figure things out when you are the patient is wonderful.  However, your stressed situation doesn't obviate the need for you to think about who is reading what you have to say. Being dismissive of those who went before and putting out opinion as fact is not ok.  And, finally, if you bother to read the data I have presented you will find that my OPINION, quite CONTRARY to your PRONOUNCEMENT, about the unpopularity of vaccines (and flying in the face of one who took six incredibly painful IM vaccine injections every 2 weeks for 6 months!!!!!!!!!!!!!!!….along with my 33 other meager, uncontrolled ratties!!!!) was this:  "I still hold out hope that vaccines will be the answer to at least some, if not all, of the curing melanoma equation!!!"

We all have to choose the path we think is best for us.  Picking your poison in melanoma is an unclear crap shoot at best.  I hope the vaccine trial you have selected provides a wonderful response for your partner and many others. However, it is very clear that there is, in fact, a great deal of data that shows many current therapies DO hold promise as adjuvant treatment for melanoma as well.  celeste

Well, ET-SF:  What sort of scientist are you exactly?  Not controlled?  Vaccines are unpopular?  Hmmmm….  If you bothered to read my study you would have seen it actually provided you with more data about a vaccine.  My study was a combo of nivolizumab/opdivo and 6 peptide vaccines.  We ratties, with our small, lame, uncontrolled numbers…some of us now dead…you're welcome….provided the needed info that IT DID NOT WORK!!!  Nivo did, but the peptide vaccine did not.

http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/05/peptide-vaccines-do-not-trigger.html

Here is the only and latest vaccine that is making any kind of head way in melanoma currently:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/08/positive-response-to-helper-peptide.html

I am a huge believer in T-vec as well as other intralesional therapies and think that they will hold a key to at least some positive results for some melanoma patients.  And while, T-vec, when injected intralesionally, causes the lysis of melanoma cells and release of tumor antigens and facilitates their processing by GM-CSF, it is not an exogenously formulated vaccine.  A scientist would understand that your characterization of it as a 'typical vaccine" would be a bit disingenuious wouldn't it?

As a 'scientist' you are comfortable with this statement????!!!!  "Little or nothing seems to be known about the effectiveness of a PD-1 blockade drug in promoting immune attacks against isolated melanoma cells and microscopic cell clusters.  Although pembrolizumab would likely up-regulate immune responses in other ways, its principal benefit of helping CD8+ T cells to retain their efficacy in hostile tumor microenvironments would not be realized (i.e. in the absence of a tumor).  As such, it may be no more effective than interferon in this application." 

Well, all I can say to that is WOW!!!!  You have entered melanoma world and know more about anti-PD1 and immunotherapy in melanoma than Ribas, Weber, Hodi, Agarwala, and all the melanoma big dogs.  That is impressive.  I mean, they have been working on this stuff for years and seem to feel they actually do understand a great deal about how anti-PD1 works to kill those "isolated melanoma cells and microscopic cell clusters".  And….uhhh yeah…those goof asses DO think it is much more effective than interferon!  But, what do they know??

Maybe you're just expounding on a "hunch"?  Folks on this site depend on what is posted here to be based in real experience or in real data.  The articles you provided Ed are from 2002, 2006, and 2001!  The first two papers provide NO data regarding outcomes.  The third paper utilized 24 patients in the treatment group and 14 in placebo.  And you're critical of small sample size?  And the outcome?  Drum roll please…….  NO STATISTICAL DIFFERENCE.  This is what impresses you????  Thank goodness, we've come a long way since then!!   Check out what some of the experts in current immunotherapy have to say.  Take your pick: 

This one has a neat slide to tell you a little more about immunotherapy and what melanoma big dogs DO know about the action of anti-PD1:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/pick-your-poison-weber-and-agarwala.html

Here is a chat between Ribas and Weber, where, among other things, ipi as adjuvant is discussed:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/pretty-darn-impressivea-chat-between.html

Like science?  Here's a post that should interest you.  It includes data from 2015 on:  Adjuvant ipilimumab vs placebo after complete resection of high-risk stage III melanoma:  a randomized, double-blind, phase 3 trial. in which it was determined that "Adjuvant ipi significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma."  Here's the link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

I am very sorry for what you and your friend are going through.  Having someone in your corner to help figure things out when you are the patient is wonderful.  However, your stressed situation doesn't obviate the need for you to think about who is reading what you have to say. Being dismissive of those who went before and putting out opinion as fact is not ok.  And, finally, if you bother to read the data I have presented you will find that my OPINION, quite CONTRARY to your PRONOUNCEMENT, about the unpopularity of vaccines (and flying in the face of one who took six incredibly painful IM vaccine injections every 2 weeks for 6 months!!!!!!!!!!!!!!!….along with my 33 other meager, uncontrolled ratties!!!!) was this:  "I still hold out hope that vaccines will be the answer to at least some, if not all, of the curing melanoma equation!!!"

We all have to choose the path we think is best for us.  Picking your poison in melanoma is an unclear crap shoot at best.  I hope the vaccine trial you have selected provides a wonderful response for your partner and many others. However, it is very clear that there is, in fact, a great deal of data that shows many current therapies DO hold promise as adjuvant treatment for melanoma as well.  celeste

I think we're all in this together.  Are we not?

The study you participated in is promising, to be sure.  However, it is not a controlled study, and the sample sizes are small.  (Small sample sizes are a concern I also have about the double-blind vaccine study, but I am still persuaded by the statistical findings.)  Although this study would have been helpful in our decision making, it is still not quite what we were looking for.

I also realize vaccine treatments are unpopular and greeted with considerable skepticism.  However, as a scientist, I don't really care about popular opinions.  I believe the results are what they are.  I find the investigators' systematic approach to the evaluation of this drug to be of an unusually high scientific caliber.  There are many approaches to vaccination, and not all vaccines are the same.  Few would argue T-VEC is ineffective, for instance, and yet it is a novel vaccine.  The polyvalent expression of the seviprotimut-L addresses (and hopefully solves) a problem common to many vaccines that have failed — that of the ability of the tumor to mutate around attack against limited numbers of antigens.

On a personal note, I'm sorry that my expressions (e.g. "kettle of fish") have apparently offended you.  That's simply how I talk and write.

On a personal note, I'm sorry that my expressions (e.g. "kettle of fish") have apparently offended you.  That's simply how I talk and write.

On a personal note, I'm sorry that my expressions (e.g. "kettle of fish") have apparently offended you.  That's simply how I talk and write.

And finally, you take this dig at me: "Some of us are here actually doing it….not reading about it for others."  I frankly find that condescending and extremely unsupportive.

I am here because the woman I love with all my heart has cancer.  YOU BET I am going to read about this disease and its treatment for her with every ounce of my ability!  Her disease is my disease.  If she suffers, I suffer too.  If she dies, I fear most of me will die with her.  Sure, she has a lot more skin in the game (another expression, sorry), but I'm in this with her as much as I can be.  I am her partner in every sense — and her caregiver.  So if I can use my scientific background to digest research papers at a different level than she can, you can BET I'm going to do that for her.  I will use whatever I can to help her with her disease. 

So please do not dismiss my role as partner and caregiver in this manner.  You have been at this for 5+ years, and I congratulate you for being a fighter and survivor.  We have been at this since August 12 and are desperately climbing a very steep learning curve.  If you have knowledge to share with us, please share it (as you have done).  But please leave the attitude behind.  My goal — her goal — is one thing only.  It is to fight this disease and win.

And finally, you take this dig at me: "Some of us are here actually doing it….not reading about it for others."  I frankly find that condescending and extremely unsupportive.

I am here because the woman I love with all my heart has cancer.  YOU BET I am going to read about this disease and its treatment for her with every ounce of my ability!  Her disease is my disease.  If she suffers, I suffer too.  If she dies, I fear most of me will die with her.  Sure, she has a lot more skin in the game (another expression, sorry), but I'm in this with her as much as I can be.  I am her partner in every sense — and her caregiver.  So if I can use my scientific background to digest research papers at a different level than she can, you can BET I'm going to do that for her.  I will use whatever I can to help her with her disease. 

So please do not dismiss my role as partner and caregiver in this manner.  You have been at this for 5+ years, and I congratulate you for being a fighter and survivor.  We have been at this since August 12 and are desperately climbing a very steep learning curve.  If you have knowledge to share with us, please share it (as you have done).  But please leave the attitude behind.  My goal — her goal — is one thing only.  It is to fight this disease and win.

And finally, you take this dig at me: "Some of us are here actually doing it….not reading about it for others."  I frankly find that condescending and extremely unsupportive.

I am here because the woman I love with all my heart has cancer.  YOU BET I am going to read about this disease and its treatment for her with every ounce of my ability!  Her disease is my disease.  If she suffers, I suffer too.  If she dies, I fear most of me will die with her.  Sure, she has a lot more skin in the game (another expression, sorry), but I'm in this with her as much as I can be.  I am her partner in every sense — and her caregiver.  So if I can use my scientific background to digest research papers at a different level than she can, you can BET I'm going to do that for her.  I will use whatever I can to help her with her disease. 

So please do not dismiss my role as partner and caregiver in this manner.  You have been at this for 5+ years, and I congratulate you for being a fighter and survivor.  We have been at this since August 12 and are desperately climbing a very steep learning curve.  If you have knowledge to share with us, please share it (as you have done).  But please leave the attitude behind.  My goal — her goal — is one thing only.  It is to fight this disease and win.

Dear ST    I share with you some important characteristics. 1) I am a caregive and live for the love of my life 2)  I am a scientist and believe in the power while recognzing the limits of our science.

I also have a pragmatic understanding of how the science is translated to the clinical. I want all to work out for you and your partner. We all do. Having done this for 11 years I know  the false hopesc and dashed dreams that this study or that. or this doctor or that can bring. All of them are borne to you by the biopsy , the scan, the skin lesion that is undeniably there.

  Do not give up. I know you won't. But try to learn from those who are travelling this path with you that you must sometimes temper what looks like a sure thing with the reality of the vicious nature of the disease. The studies of  the Polynoma vaccine are encouraging but not overwhelming. The statistics are not in yet. We don't know the final story for adjuvant  therapy for anti-pd1 but the statistics for Celeste"s trial are in for about three years out.  They validate a positive effect.  We are trying to tell you  that there is no certainty but the fervor of your effort and wonderful time that you have already spent together. Melanoma world can be a harsh place  and being dogmatic serves little purpose.

Dear ST    I share with you some important characteristics. 1) I am a caregive and live for the love of my life 2)  I am a scientist and believe in the power while recognzing the limits of our science.

I also have a pragmatic understanding of how the science is translated to the clinical. I want all to work out for you and your partner. We all do. Having done this for 11 years I know  the false hopesc and dashed dreams that this study or that. or this doctor or that can bring. All of them are borne to you by the biopsy , the scan, the skin lesion that is undeniably there.

  Do not give up. I know you won't. But try to learn from those who are travelling this path with you that you must sometimes temper what looks like a sure thing with the reality of the vicious nature of the disease. The studies of  the Polynoma vaccine are encouraging but not overwhelming. The statistics are not in yet. We don't know the final story for adjuvant  therapy for anti-pd1 but the statistics for Celeste"s trial are in for about three years out.  They validate a positive effect.  We are trying to tell you  that there is no certainty but the fervor of your effort and wonderful time that you have already spent together. Melanoma world can be a harsh place  and being dogmatic serves little purpose.

Dear ST    I share with you some important characteristics. 1) I am a caregive and live for the love of my life 2)  I am a scientist and believe in the power while recognzing the limits of our science.

I also have a pragmatic understanding of how the science is translated to the clinical. I want all to work out for you and your partner. We all do. Having done this for 11 years I know  the false hopesc and dashed dreams that this study or that. or this doctor or that can bring. All of them are borne to you by the biopsy , the scan, the skin lesion that is undeniably there.

  Do not give up. I know you won't. But try to learn from those who are travelling this path with you that you must sometimes temper what looks like a sure thing with the reality of the vicious nature of the disease. The studies of  the Polynoma vaccine are encouraging but not overwhelming. The statistics are not in yet. We don't know the final story for adjuvant  therapy for anti-pd1 but the statistics for Celeste"s trial are in for about three years out.  They validate a positive effect.  We are trying to tell you  that there is no certainty but the fervor of your effort and wonderful time that you have already spent together. Melanoma world can be a harsh place  and being dogmatic serves little purpose.

I'm sorry, Morris.  I'm ready to impale myself on a sword this morning for you and Celeste.  Is that what you want?

I have neither confirmed nor denied a thing, nor elaborated, nor restated uninformed opinions, because I'm JUST. TRYING. TO. RESTORE. SOME. CALM.  It's pointless to discuss anything with an angry person bent on winning and asserting dominance. 

I do not disrespect or discount the contributions of volunteers.  I do not discount or disrespect the research that they have made possible.  ET has become a player in this whole thing, and I certainly don't disrespect or discount HER!  Quite the opposite. 

Are there gaps in my knowledge?  Yes!  Isn't that painfully obvious in this thread?  Do you think anyone would conclude otherwise?

What I wrote was based on many discussions and digging in attempt to pick a trial in the limited time window we had.  I did not find the ipi vs. placebo double blind phase III study.  Just didn't.  That study does show benefit.

I never said T-VEC was a "typical" vaccine.  I said it functions as a "novel" vaccine.  It does, does it not?

And there is actually some good work behind the Polynoma vaccine.  I never said I thought it was a blockbuster drug/treatment.  I expect it will be of measured benefit, just like I expect the keytruda would be of measured benefit in this application.  I do wonder whether people here have studied the primary literature on the vaccine.

If someone is wrong about something, does that necessitate a personal attack to discredit the person and destroy them at a time when they are very fragile?  Or is it perhaps better to say, "not so… have a look at this study?"  Academics are capable of launching some pretty gut-wrenching attacks on the works of others, but I don't think I've ever heard one academic argue, "Well, you're just an idiot."

I have learned something from this exchange, besides that there is value to adjuvant immunotherapy for resected stage III (something I never doubted, but just questioned the magnitude of the benefit).  I've learned that discussing any life-and-death issue involves walking on eggshells, and people will get offended by any mis-step.  They will come after you very angrily and sometimes try to rip you apart.  That is not the type of support ET and I need right now.  I need to stay focused.  So I will lurk.  I will not post or participate in any way.  Consider me gone — a ghost.  You have exorcised this list of the evil scientists, having punished me even more strongly than a research immunologist (!!) who was roundly chastised for having used an unpopular (there's that word again) adjuvant therapy.

Now back to our regularly scheduled flood waters…

I'm sorry, Morris.  I'm ready to impale myself on a sword this morning for you and Celeste.  Is that what you want?

I have neither confirmed nor denied a thing, nor elaborated, nor restated uninformed opinions, because I'm JUST. TRYING. TO. RESTORE. SOME. CALM.  It's pointless to discuss anything with an angry person bent on winning and asserting dominance. 

I do not disrespect or discount the contributions of volunteers.  I do not discount or disrespect the research that they have made possible.  ET has become a player in this whole thing, and I certainly don't disrespect or discount HER!  Quite the opposite. 

Are there gaps in my knowledge?  Yes!  Isn't that painfully obvious in this thread?  Do you think anyone would conclude otherwise?

What I wrote was based on many discussions and digging in attempt to pick a trial in the limited time window we had.  I did not find the ipi vs. placebo double blind phase III study.  Just didn't.  That study does show benefit.

I never said T-VEC was a "typical" vaccine.  I said it functions as a "novel" vaccine.  It does, does it not?

And there is actually some good work behind the Polynoma vaccine.  I never said I thought it was a blockbuster drug/treatment.  I expect it will be of measured benefit, just like I expect the keytruda would be of measured benefit in this application.  I do wonder whether people here have studied the primary literature on the vaccine.

If someone is wrong about something, does that necessitate a personal attack to discredit the person and destroy them at a time when they are very fragile?  Or is it perhaps better to say, "not so… have a look at this study?"  Academics are capable of launching some pretty gut-wrenching attacks on the works of others, but I don't think I've ever heard one academic argue, "Well, you're just an idiot."

I have learned something from this exchange, besides that there is value to adjuvant immunotherapy for resected stage III (something I never doubted, but just questioned the magnitude of the benefit).  I've learned that discussing any life-and-death issue involves walking on eggshells, and people will get offended by any mis-step.  They will come after you very angrily and sometimes try to rip you apart.  That is not the type of support ET and I need right now.  I need to stay focused.  So I will lurk.  I will not post or participate in any way.  Consider me gone — a ghost.  You have exorcised this list of the evil scientists, having punished me even more strongly than a research immunologist (!!) who was roundly chastised for having used an unpopular (there's that word again) adjuvant therapy.

Now back to our regularly scheduled flood waters…

I'm sorry, Morris.  I'm ready to impale myself on a sword this morning for you and Celeste.  Is that what you want?

I have neither confirmed nor denied a thing, nor elaborated, nor restated uninformed opinions, because I'm JUST. TRYING. TO. RESTORE. SOME. CALM.  It's pointless to discuss anything with an angry person bent on winning and asserting dominance. 

I do not disrespect or discount the contributions of volunteers.  I do not discount or disrespect the research that they have made possible.  ET has become a player in this whole thing, and I certainly don't disrespect or discount HER!  Quite the opposite. 

Are there gaps in my knowledge?  Yes!  Isn't that painfully obvious in this thread?  Do you think anyone would conclude otherwise?

What I wrote was based on many discussions and digging in attempt to pick a trial in the limited time window we had.  I did not find the ipi vs. placebo double blind phase III study.  Just didn't.  That study does show benefit.

I never said T-VEC was a "typical" vaccine.  I said it functions as a "novel" vaccine.  It does, does it not?

And there is actually some good work behind the Polynoma vaccine.  I never said I thought it was a blockbuster drug/treatment.  I expect it will be of measured benefit, just like I expect the keytruda would be of measured benefit in this application.  I do wonder whether people here have studied the primary literature on the vaccine.

If someone is wrong about something, does that necessitate a personal attack to discredit the person and destroy them at a time when they are very fragile?  Or is it perhaps better to say, "not so… have a look at this study?"  Academics are capable of launching some pretty gut-wrenching attacks on the works of others, but I don't think I've ever heard one academic argue, "Well, you're just an idiot."

I have learned something from this exchange, besides that there is value to adjuvant immunotherapy for resected stage III (something I never doubted, but just questioned the magnitude of the benefit).  I've learned that discussing any life-and-death issue involves walking on eggshells, and people will get offended by any mis-step.  They will come after you very angrily and sometimes try to rip you apart.  That is not the type of support ET and I need right now.  I need to stay focused.  So I will lurk.  I will not post or participate in any way.  Consider me gone — a ghost.  You have exorcised this list of the evil scientists, having punished me even more strongly than a research immunologist (!!) who was roundly chastised for having used an unpopular (there's that word again) adjuvant therapy.

Now back to our regularly scheduled flood waters…

PS Another misstep… I posted this in reply to your accommodating response, not your more impatient one later.  Sorry…. I'm just exhausted…

PS Another misstep… I posted this in reply to your accommodating response, not your more impatient one later.  Sorry…. I'm just exhausted…

PS Another misstep… I posted this in reply to your accommodating response, not your more impatient one later.  Sorry…. I'm just exhausted…

SF – I hope you will reconsider your decision to merely lurk.  I, for one, welcome different viewpoints and respectful debate.  The science is not settled in the world of melanoma.  Anyone who has a different reasoned take on any particular study should by all means speak up as long as it is clearly noted as opinion.  Continue to take good care of ET and stay dry.  I hope to see you posting again soon.

SF – I hope you will reconsider your decision to merely lurk.  I, for one, welcome different viewpoints and respectful debate.  The science is not settled in the world of melanoma.  Anyone who has a different reasoned take on any particular study should by all means speak up as long as it is clearly noted as opinion.  Continue to take good care of ET and stay dry.  I hope to see you posting again soon.

SF – I hope you will reconsider your decision to merely lurk.  I, for one, welcome different viewpoints and respectful debate.  The science is not settled in the world of melanoma.  Anyone who has a different reasoned take on any particular study should by all means speak up as long as it is clearly noted as opinion.  Continue to take good care of ET and stay dry.  I hope to see you posting again soon.

ET-SF,

I'm sorry that you had to endure this ridiculous personal attack.

Bubbles, thanks for all you do for this board, but the tone of your responses in this thread was really uncalled for. Just say "I feel strongly that what you said about anti-PD1 in the adjuvant setting is misinformed and these are the reasons why" and then provide the links. Be as strident as you feel you need to be without the "air quotes", the passive-aggressiveness, and the personal attacks. To present the information the way you did was very hurtful to the feelings of someone who's life is clearly being turned upside by Melanoma and presents you in a very negative light.

A little bit of defensiveness about what you perceive as diminution of the contributions of a trial you participated in is understandable I suppose, but this was way too much.

ET-SF,

I'm sorry that you had to endure this ridiculous personal attack.

Bubbles, thanks for all you do for this board, but the tone of your responses in this thread was really uncalled for. Just say "I feel strongly that what you said about anti-PD1 in the adjuvant setting is misinformed and these are the reasons why" and then provide the links. Be as strident as you feel you need to be without the "air quotes", the passive-aggressiveness, and the personal attacks. To present the information the way you did was very hurtful to the feelings of someone who's life is clearly being turned upside by Melanoma and presents you in a very negative light.

A little bit of defensiveness about what you perceive as diminution of the contributions of a trial you participated in is understandable I suppose, but this was way too much.

ET-SF,

I'm sorry that you had to endure this ridiculous personal attack.

Bubbles, thanks for all you do for this board, but the tone of your responses in this thread was really uncalled for. Just say "I feel strongly that what you said about anti-PD1 in the adjuvant setting is misinformed and these are the reasons why" and then provide the links. Be as strident as you feel you need to be without the "air quotes", the passive-aggressiveness, and the personal attacks. To present the information the way you did was very hurtful to the feelings of someone who's life is clearly being turned upside by Melanoma and presents you in a very negative light.

A little bit of defensiveness about what you perceive as diminution of the contributions of a trial you participated in is understandable I suppose, but this was way too much.

ET-SF  Keep fighting the good fight!  Celeste brings to this forum an invaluable wealth of knowledge and experience and we would all be worse off without her.  I also wish she could share her wisdom without the attitude.  The sarcasm comes across as mean-sprited and undercuts her message.  

We are all dealing with a horrible disease.

ET-SF  Keep fighting the good fight!  Celeste brings to this forum an invaluable wealth of knowledge and experience and we would all be worse off without her.  I also wish she could share her wisdom without the attitude.  The sarcasm comes across as mean-sprited and undercuts her message.  

We are all dealing with a horrible disease.

ET-SF  Keep fighting the good fight!  Celeste brings to this forum an invaluable wealth of knowledge and experience and we would all be worse off without her.  I also wish she could share her wisdom without the attitude.  The sarcasm comes across as mean-sprited and undercuts her message.  

We are all dealing with a horrible disease.

In case you'd like to read the data for yourself:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

Actually, ETSF…there IS data with immunotherapy and NED/adjuvant treatment.  Just happen to be a rattie in that world myself.  Be careful the "data" you impart!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  Vaccines have yet to be effective in melanoma.  I think they will be eventually….but right now….big question mark.  Everyone must decide what is best for them…but some of us are doing very well "killing off stray melanoma cells" …in our "kettle of fish".  Some of us are here actually doing it….not reading about it for others.  Thank goodness I had a "Sherman Tank" for my NED Stage IV melanoma.  I am now 5 years NED after Nivolumab, NED arm.  Melanoma patient since 2003. With a 70% plus response rate in my NED arm, I think that shows "benefit"….don't you?  I hope that helps!  Celeste