GSK/Amplimmune -PD1 trial

Phase 1 trials offer incredible potential for participants.  MD Anderson's Phase 1 Clinical Trial center is experiencing results equal to, or better than the "standard of care" drugs currently approved by the FDA for Stage IV Cancers.  With the current Anti-PD1 trials, there is over 3 years of trial results from BMS and now Merck demonstrating a superb efficacy over available drugs.  The number of people in my Merck Anti-PD1 trial began at 180 people worldwide, not 10, and they have added a number of new arms to include patients that had already done Yervoy.  BMS has had over 300 people in it's Anti-PD1 trials and is also adding more arms.  The BEAUTY of a Phase 1 trial is that you KNOW that you are getting the drug while waiting until a later phase will put you into a randomized situation.  The newest Merck trials opening are randomized to low dose, high dose, and a "dealers choice" chemo like Temodar or which ever chemo drug the trial chooses.  

That being said, it is up to the patient to research every therapy available for his/her particular cancer.  Anyone watching the Anti-PD1 space over the last 2 years knows of the success the drug is seeing.  Yes, different pharmaceutical companies may have different results, but the concep tis now proven short term and shoud not be relegated to "people who have already had all the standard treatments".  I did biochemotherapy and my Oncologist at the time just expected me to go on to Yervoy.  I chose a Phase1 Anti-Pd1 trial instead as my research indicated that it was a better choice.  

Bottom line, is that I was diagnosed Stage IV Metastatic Melanoma in March of 2011.  Tomorrow I go in for my 36 week scans after receiving infusions every 2 weeks since March of this year.  My 12 week and 24 week scans have shown significant tumor reduction and my case is not unique.  There are many of us having similar results.  ASCO abstracts this year showed that so far, only tumors expressing the PD Ligand respond to Anti-PD1 therapy, and the numbers from ASCO, as high as 35% response rate, are not based upon screening for the PD ligand first, so once they are testing for it, the response rate will certainly increase.  

The previous posters comments start with "please be aware" and sounds a little ominous compared to the reality of this therapy and it's trials. I would say that anyone that finds themselves with this disease should listen to Melanoma specialists and researchers and consider quality of life when determining a therapy.  There have been no "good" options for Stage 4 Melanoma until the past 2 years and the only reasons we are seeing the first good options in 20 years is due to Phase 1 trials.  I'm a proud guinea pig that owes his life to this trial.  Many that come after me will also owe their lives to Phase 1 trials and it's participants.   

Peace,

Robert

Robert, I am sure you have now read my comments above.  I still do not think that there are any great options currently approved for stage IV.  Nothing that was approved in the past two years has proved to be a great improvement over the IL-2 approved in 1998.  The main improvement has been that there are more fairly poor choices than ever before and that current trials and research indicate that quite likely there will be more beneficial treatments in the future.  We are still a fair ways from the great improvement that we want to see, but we are getting to the point that many of us will live longer than the Doctors imagined possible when we first came down with melanoma and even longer than when we were finally diagnosed!  Pretty bad when we have to go to a subset of a subset of a subset to even get to a 25% chance of extending life.  A 25% cure rate for stage Iv would be "GREAT" by todays standards for melanoma.  Many people are shocked when theyblearn that the newly approved miracle drugs only provide around a 15% chance of extending ones life by any noticable amount.  (I should go to the "Off-topic" BB to go into what I fear the future will bring from either of our political parties for the future expenditures to allow the numbers to improve.  We used to have some great discussions there.)

Robert, I am sure you have now read my comments above.  I still do not think that there are any great options currently approved for stage IV.  Nothing that was approved in the past two years has proved to be a great improvement over the IL-2 approved in 1998.  The main improvement has been that there are more fairly poor choices than ever before and that current trials and research indicate that quite likely there will be more beneficial treatments in the future.  We are still a fair ways from the great improvement that we want to see, but we are getting to the point that many of us will live longer than the Doctors imagined possible when we first came down with melanoma and even longer than when we were finally diagnosed!  Pretty bad when we have to go to a subset of a subset of a subset to even get to a 25% chance of extending life.  A 25% cure rate for stage Iv would be "GREAT" by todays standards for melanoma.  Many people are shocked when theyblearn that the newly approved miracle drugs only provide around a 15% chance of extending ones life by any noticable amount.  (I should go to the "Off-topic" BB to go into what I fear the future will bring from either of our political parties for the future expenditures to allow the numbers to improve.  We used to have some great discussions there.)

Robert, I am sure you have now read my comments above.  I still do not think that there are any great options currently approved for stage IV.  Nothing that was approved in the past two years has proved to be a great improvement over the IL-2 approved in 1998.  The main improvement has been that there are more fairly poor choices than ever before and that current trials and research indicate that quite likely there will be more beneficial treatments in the future.  We are still a fair ways from the great improvement that we want to see, but we are getting to the point that many of us will live longer than the Doctors imagined possible when we first came down with melanoma and even longer than when we were finally diagnosed!  Pretty bad when we have to go to a subset of a subset of a subset to even get to a 25% chance of extending life.  A 25% cure rate for stage Iv would be "GREAT" by todays standards for melanoma.  Many people are shocked when theyblearn that the newly approved miracle drugs only provide around a 15% chance of extending ones life by any noticable amount.  (I should go to the "Off-topic" BB to go into what I fear the future will bring from either of our political parties for the future expenditures to allow the numbers to improve.  We used to have some great discussions there.)

Phase 1 trials offer incredible potential for participants.  MD Anderson's Phase 1 Clinical Trial center is experiencing results equal to, or better than the "standard of care" drugs currently approved by the FDA for Stage IV Cancers.  With the current Anti-PD1 trials, there is over 3 years of trial results from BMS and now Merck demonstrating a superb efficacy over available drugs.  The number of people in my Merck Anti-PD1 trial began at 180 people worldwide, not 10, and they have added a number of new arms to include patients that had already done Yervoy.  BMS has had over 300 people in it's Anti-PD1 trials and is also adding more arms.  The BEAUTY of a Phase 1 trial is that you KNOW that you are getting the drug while waiting until a later phase will put you into a randomized situation.  The newest Merck trials opening are randomized to low dose, high dose, and a "dealers choice" chemo like Temodar or which ever chemo drug the trial chooses.  

That being said, it is up to the patient to research every therapy available for his/her particular cancer.  Anyone watching the Anti-PD1 space over the last 2 years knows of the success the drug is seeing.  Yes, different pharmaceutical companies may have different results, but the concep tis now proven short term and shoud not be relegated to "people who have already had all the standard treatments".  I did biochemotherapy and my Oncologist at the time just expected me to go on to Yervoy.  I chose a Phase1 Anti-Pd1 trial instead as my research indicated that it was a better choice.  

Bottom line, is that I was diagnosed Stage IV Metastatic Melanoma in March of 2011.  Tomorrow I go in for my 36 week scans after receiving infusions every 2 weeks since March of this year.  My 12 week and 24 week scans have shown significant tumor reduction and my case is not unique.  There are many of us having similar results.  ASCO abstracts this year showed that so far, only tumors expressing the PD Ligand respond to Anti-PD1 therapy, and the numbers from ASCO, as high as 35% response rate, are not based upon screening for the PD ligand first, so once they are testing for it, the response rate will certainly increase.  

The previous posters comments start with "please be aware" and sounds a little ominous compared to the reality of this therapy and it's trials. I would say that anyone that finds themselves with this disease should listen to Melanoma specialists and researchers and consider quality of life when determining a therapy.  There have been no "good" options for Stage 4 Melanoma until the past 2 years and the only reasons we are seeing the first good options in 20 years is due to Phase 1 trials.  I'm a proud guinea pig that owes his life to this trial.  Many that come after me will also owe their lives to Phase 1 trials and it's participants.   

Peace,

Robert

Phase 1 trials offer incredible potential for participants.  MD Anderson's Phase 1 Clinical Trial center is experiencing results equal to, or better than the "standard of care" drugs currently approved by the FDA for Stage IV Cancers.  With the current Anti-PD1 trials, there is over 3 years of trial results from BMS and now Merck demonstrating a superb efficacy over available drugs.  The number of people in my Merck Anti-PD1 trial began at 180 people worldwide, not 10, and they have added a number of new arms to include patients that had already done Yervoy.  BMS has had over 300 people in it's Anti-PD1 trials and is also adding more arms.  The BEAUTY of a Phase 1 trial is that you KNOW that you are getting the drug while waiting until a later phase will put you into a randomized situation.  The newest Merck trials opening are randomized to low dose, high dose, and a "dealers choice" chemo like Temodar or which ever chemo drug the trial chooses.  

That being said, it is up to the patient to research every therapy available for his/her particular cancer.  Anyone watching the Anti-PD1 space over the last 2 years knows of the success the drug is seeing.  Yes, different pharmaceutical companies may have different results, but the concep tis now proven short term and shoud not be relegated to "people who have already had all the standard treatments".  I did biochemotherapy and my Oncologist at the time just expected me to go on to Yervoy.  I chose a Phase1 Anti-Pd1 trial instead as my research indicated that it was a better choice.  

Bottom line, is that I was diagnosed Stage IV Metastatic Melanoma in March of 2011.  Tomorrow I go in for my 36 week scans after receiving infusions every 2 weeks since March of this year.  My 12 week and 24 week scans have shown significant tumor reduction and my case is not unique.  There are many of us having similar results.  ASCO abstracts this year showed that so far, only tumors expressing the PD Ligand respond to Anti-PD1 therapy, and the numbers from ASCO, as high as 35% response rate, are not based upon screening for the PD ligand first, so once they are testing for it, the response rate will certainly increase.  

The previous posters comments start with "please be aware" and sounds a little ominous compared to the reality of this therapy and it's trials. I would say that anyone that finds themselves with this disease should listen to Melanoma specialists and researchers and consider quality of life when determining a therapy.  There have been no "good" options for Stage 4 Melanoma until the past 2 years and the only reasons we are seeing the first good options in 20 years is due to Phase 1 trials.  I'm a proud guinea pig that owes his life to this trial.  Many that come after me will also owe their lives to Phase 1 trials and it's participants.   

Peace,

Robert

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.

I was a participant in BMS Phase 1B trial of their anti-PD-1. It was a dose escalation trial with looking at both maximum tolerated dose and efficacy in terms of overall response and the duration of progression free response, The point I wish to make is that not all Phase 1 trials are the same. They do tend start out small but often are expanded based on early results with respect to toxicity and tumor response. Some get shut down.

It is incredably dificult to make an informed choice as the information is often experiential or technical.  Patients on Blogs and Forums provide us with most of the former while the companies tightly control the later and do so to the extent that aggregated data isn't even available to participating oncologists until peer reviewed papers are presented.

 Some of the participants in early trials of anti-PD-1 and  the recently approved targeted and immunotherapies have been pushing BMS to move forward more rapidly with advanced trials of their version. They recently announced two new trials: 

NCT01721746 which is for patients who have progessed after treatment with a  CTLA-4 therapy, and

NCT 0172772 which is for previously untrearted, unresectable or metastatic Stage III or IV melanoma.

These are large studies (390 & 410 respectively) but involve randomization to placebo and standard chemo arms and because they are traditional Phase III trials do not allow patients who show progress on the comparator arms to crossover to the anti-PD-1. These trials were listed earlier this month and are not yet recruiting. Patients and the entire melanoma community should put pressure on BMS to revise these trials to insure access to anti-PD-1 for all participants. Yes it will complicate the science but it will save lives. WE need to learn from the experience of Aids Activism which brought together patients, clinicians, researchers. politicians and citizens to speed access to life saving drugs.