Evaluating Clinical Trials

Julie-

My hope that if all goes well I will be doing the Phase 2 Adoptive Cell Therapy with low dose IL-2 and ipi at MDA. This I believe is similar to what you're looking at; a protein/antigen specific cell therapy. I had to be HLA-0201 Positive as well as Mart 1 positive.

How I chose was my oncologist and I sat down looked at different options. The adoptive cell stuck out. There was a similar trial in Chicago at Loyola University that was HLA-A2 and tyrosinaise positive. Since travel was not an issue and the trail at MDA was Phase 2 and included ipi with low dose IL-2; we both felt that it was a better option than Loyola which was Phase 1 with the cell therapy and low dose IL-2. My tumors biopsied also expressed weakly for tyrosinaise and strong for Mart 1. Hopefully right decision. I'm all for furthering science and hopefully contributing to helping people but I'd be lying if I didn't tell you that I have a bigger interest in sticking around for my wife, 12 yr old son and 9 year old daughter.

Is this the trial at UCLA? I know that Ribas, Casssian Yee, Allison and can't remember other guy are all working on these types of therapies. They're all on some immunology dream team.

On a side note, I went to University of Chicago to see Jason Luke. He's a big phase 1 trial guy. He said lots in the pipeline. One was what he described as a "smart bomb" chemo. He liked my plan but said there are options especially for us who have been down the ipi, pembro or nivo road. I just pray I get my cells reinfused back into me on Sept 22nd.

Going through all the trials is a lot…overload!!!!

Wishing you the best.

Josh

Julie-

My hope that if all goes well I will be doing the Phase 2 Adoptive Cell Therapy with low dose IL-2 and ipi at MDA. This I believe is similar to what you're looking at; a protein/antigen specific cell therapy. I had to be HLA-0201 Positive as well as Mart 1 positive.

How I chose was my oncologist and I sat down looked at different options. The adoptive cell stuck out. There was a similar trial in Chicago at Loyola University that was HLA-A2 and tyrosinaise positive. Since travel was not an issue and the trail at MDA was Phase 2 and included ipi with low dose IL-2; we both felt that it was a better option than Loyola which was Phase 1 with the cell therapy and low dose IL-2. My tumors biopsied also expressed weakly for tyrosinaise and strong for Mart 1. Hopefully right decision. I'm all for furthering science and hopefully contributing to helping people but I'd be lying if I didn't tell you that I have a bigger interest in sticking around for my wife, 12 yr old son and 9 year old daughter.

Is this the trial at UCLA? I know that Ribas, Casssian Yee, Allison and can't remember other guy are all working on these types of therapies. They're all on some immunology dream team.

On a side note, I went to University of Chicago to see Jason Luke. He's a big phase 1 trial guy. He said lots in the pipeline. One was what he described as a "smart bomb" chemo. He liked my plan but said there are options especially for us who have been down the ipi, pembro or nivo road. I just pray I get my cells reinfused back into me on Sept 22nd.

Going through all the trials is a lot…overload!!!!

Wishing you the best.

Josh

Julie-

My hope that if all goes well I will be doing the Phase 2 Adoptive Cell Therapy with low dose IL-2 and ipi at MDA. This I believe is similar to what you're looking at; a protein/antigen specific cell therapy. I had to be HLA-0201 Positive as well as Mart 1 positive.

How I chose was my oncologist and I sat down looked at different options. The adoptive cell stuck out. There was a similar trial in Chicago at Loyola University that was HLA-A2 and tyrosinaise positive. Since travel was not an issue and the trail at MDA was Phase 2 and included ipi with low dose IL-2; we both felt that it was a better option than Loyola which was Phase 1 with the cell therapy and low dose IL-2. My tumors biopsied also expressed weakly for tyrosinaise and strong for Mart 1. Hopefully right decision. I'm all for furthering science and hopefully contributing to helping people but I'd be lying if I didn't tell you that I have a bigger interest in sticking around for my wife, 12 yr old son and 9 year old daughter.

Is this the trial at UCLA? I know that Ribas, Casssian Yee, Allison and can't remember other guy are all working on these types of therapies. They're all on some immunology dream team.

On a side note, I went to University of Chicago to see Jason Luke. He's a big phase 1 trial guy. He said lots in the pipeline. One was what he described as a "smart bomb" chemo. He liked my plan but said there are options especially for us who have been down the ipi, pembro or nivo road. I just pray I get my cells reinfused back into me on Sept 22nd.

Going through all the trials is a lot…overload!!!!

Wishing you the best.

Josh

Julie,

It's a great question and I struggle with it as well.  I'm anxious to hear if others have any good advice.  If it's a phase II or III trial I try to find the results of the previous phase to see what type of success they've had.  The trials are getting more and more complicated and thus harder and harder to understand.  Gone are the days of describing a trial as cutting the parking break or foot break on the immune system.  There's a whole lot of other varibles going into these trials. 

I know these doctors/researchers really want to fill their own trials but for the most part I've always felt they have had my best interest in mind with their advice.  One question that has worked well for me when I've had some tough choices is "What would you do in my shoes and why?" 

Good luck with your upcoming choices.  It sounds like you are in a great place for options.

Brian

Julie,

It's a great question and I struggle with it as well.  I'm anxious to hear if others have any good advice.  If it's a phase II or III trial I try to find the results of the previous phase to see what type of success they've had.  The trials are getting more and more complicated and thus harder and harder to understand.  Gone are the days of describing a trial as cutting the parking break or foot break on the immune system.  There's a whole lot of other varibles going into these trials. 

I know these doctors/researchers really want to fill their own trials but for the most part I've always felt they have had my best interest in mind with their advice.  One question that has worked well for me when I've had some tough choices is "What would you do in my shoes and why?" 

Good luck with your upcoming choices.  It sounds like you are in a great place for options.

Brian

Julie,

It's a great question and I struggle with it as well.  I'm anxious to hear if others have any good advice.  If it's a phase II or III trial I try to find the results of the previous phase to see what type of success they've had.  The trials are getting more and more complicated and thus harder and harder to understand.  Gone are the days of describing a trial as cutting the parking break or foot break on the immune system.  There's a whole lot of other varibles going into these trials. 

I know these doctors/researchers really want to fill their own trials but for the most part I've always felt they have had my best interest in mind with their advice.  One question that has worked well for me when I've had some tough choices is "What would you do in my shoes and why?" 

Good luck with your upcoming choices.  It sounds like you are in a great place for options.

Brian

Hey Julie,

Sorry you are having to ponder this…but it is a really good question.  Choosing my trial was pretty easy.  There weren't many options back in 2010!!!!  I looked first at a vaccine trial at Vanderbilt.  To be honest, it was more the way I was treated and how the trial was being "sold", as though it was a used car, that caused me to walk away.  Though in fact, there was little prior data to support the use of the particular vaccine.  However, it turned out to be a good decision, because the trial was canceled a year or so later as the control arm of patients NOT getting the vaccine were doing better than those who did.

The Nivolumab (Opdivo) trial I participated in caught my husband's attention intially because it did include vaccines!  Back then, vaccines were the "ta-dah" that was going to take care of melanoma!!!  (I still hope that someday they will!!) Ipi was not approved.  Immunotherapy was NOT on everybody's lips. BRAF inhibitors were in trials and stories of miracles were making the news…but still not FDA approved.  So…..I was accepted into the first arm, lowest dose of my Phase 1, nivo/with vaccine melanoma trial.  It lasted 2 1/2 years.  And I am still here, though not all my fellow ratties are.  We learned in 2013 that the peptide vaccines did absolutely NOTHING to help us….oh, well…hopefully nobody else will have to endure those 6 painful injections every 2 weeks.

Luckily, today, things are much different.  There are many more melanoma trials available…which is good.  But now that ipi, anti-PD1 and the BRAF inhibitors are FDA approved and available and many more folks with melanoma have taken them, making exclusions to trial participation very complicated.  Additionally, many trials these days are combo's….trials that pair all kinds of things, but very often immunotherapy (ipi, pembro or nivo) or BRAFi with some other drug…anything from IDO inhibitors, JAK inhibitors, intralesional therapies…etc.

PHASE.  An important thing to know.  Phase 1 trials are actually called dosing/safety trials.  EVERYBODY gets the drug.  What's being tested is how much a person can take without growing three heads…and hopefully some info is gleaned about the lower range of the dose that can stil solicit a response.  Also, this is an early trial in a drug's adventure into humans, so often, less data is out there about the drug in question.  Phase 2 trials are efficacy trials.  Here things get tricky because one arm may well be placebo as researchers try to determine how well the drug/therapy in question really works.  Phase 3 trials are comparison trials.  In the best case scenario, which is rare, the drug/therapy goes head to head with a similar drug.  It would have been very excellent to see this done comparing nivo to pembro in the early days.  It wasn't.  Now, it is pretty much a mute point since so many patients have taken them both, in trials and out, we are pretty clear that they are equivalent.  Today, a great trial would put the three main intralesionals one against the other….but I digress.  Sadly, in Phase 3 trials, the desired therapy is often compared to a lesser, undesireable one….say for instance…interferon vs Keytruda.

I have helped many folks find trials.  Here's how I look at them for others.

1.  What drug has the patient already had?  No need to spend a great deal of time on a trial you are excluded from.  Same with other disease processes that the patient may also have.  As well as tumor burden or location….as those can be inclusion/exclusion points as well.

2.  What is the data showing about the drugs being studied?  I work really hard to learn whatever the existing data is showing about that particular drug.  The earlier phase of the trial, the harder data is to find.

3.  What is the patient's tolerance of risk?  This can apply to Phase 1 and the "grow the heads" scenario or to Phase 2/3 trials in relation to getting the "bad arm".

4.  Availability. Is the trial open? This info should be listed at the top of the clinicaltrials.gov page where it should state if the trial is complete, tabulating data, or still recruiting.  Is the trial at a location the patient can access?  Sites are located at the bottom of the page.  However, both these points are not always up to date.  A trial may already be closed or new sites may have opened up.

5.  My biggest recommendation:  If you are remotely interested in ANY trial…even if access would be difficult, even if you think you may have an exclusion….CALL!!!!  It never hurts to ask and you may even learn about a new trial option that is even better for you when you talk to the trial coordinator.

Hope that helps a bit.  Good luck.  Celeste

Hey Julie,

Sorry you are having to ponder this…but it is a really good question.  Choosing my trial was pretty easy.  There weren't many options back in 2010!!!!  I looked first at a vaccine trial at Vanderbilt.  To be honest, it was more the way I was treated and how the trial was being "sold", as though it was a used car, that caused me to walk away.  Though in fact, there was little prior data to support the use of the particular vaccine.  However, it turned out to be a good decision, because the trial was canceled a year or so later as the control arm of patients NOT getting the vaccine were doing better than those who did.

The Nivolumab (Opdivo) trial I participated in caught my husband's attention intially because it did include vaccines!  Back then, vaccines were the "ta-dah" that was going to take care of melanoma!!!  (I still hope that someday they will!!) Ipi was not approved.  Immunotherapy was NOT on everybody's lips. BRAF inhibitors were in trials and stories of miracles were making the news…but still not FDA approved.  So…..I was accepted into the first arm, lowest dose of my Phase 1, nivo/with vaccine melanoma trial.  It lasted 2 1/2 years.  And I am still here, though not all my fellow ratties are.  We learned in 2013 that the peptide vaccines did absolutely NOTHING to help us….oh, well…hopefully nobody else will have to endure those 6 painful injections every 2 weeks.

Luckily, today, things are much different.  There are many more melanoma trials available…which is good.  But now that ipi, anti-PD1 and the BRAF inhibitors are FDA approved and available and many more folks with melanoma have taken them, making exclusions to trial participation very complicated.  Additionally, many trials these days are combo's….trials that pair all kinds of things, but very often immunotherapy (ipi, pembro or nivo) or BRAFi with some other drug…anything from IDO inhibitors, JAK inhibitors, intralesional therapies…etc.

PHASE.  An important thing to know.  Phase 1 trials are actually called dosing/safety trials.  EVERYBODY gets the drug.  What's being tested is how much a person can take without growing three heads…and hopefully some info is gleaned about the lower range of the dose that can stil solicit a response.  Also, this is an early trial in a drug's adventure into humans, so often, less data is out there about the drug in question.  Phase 2 trials are efficacy trials.  Here things get tricky because one arm may well be placebo as researchers try to determine how well the drug/therapy in question really works.  Phase 3 trials are comparison trials.  In the best case scenario, which is rare, the drug/therapy goes head to head with a similar drug.  It would have been very excellent to see this done comparing nivo to pembro in the early days.  It wasn't.  Now, it is pretty much a mute point since so many patients have taken them both, in trials and out, we are pretty clear that they are equivalent.  Today, a great trial would put the three main intralesionals one against the other….but I digress.  Sadly, in Phase 3 trials, the desired therapy is often compared to a lesser, undesireable one….say for instance…interferon vs Keytruda.

I have helped many folks find trials.  Here's how I look at them for others.

1.  What drug has the patient already had?  No need to spend a great deal of time on a trial you are excluded from.  Same with other disease processes that the patient may also have.  As well as tumor burden or location….as those can be inclusion/exclusion points as well.

2.  What is the data showing about the drugs being studied?  I work really hard to learn whatever the existing data is showing about that particular drug.  The earlier phase of the trial, the harder data is to find.

3.  What is the patient's tolerance of risk?  This can apply to Phase 1 and the "grow the heads" scenario or to Phase 2/3 trials in relation to getting the "bad arm".

4.  Availability. Is the trial open? This info should be listed at the top of the clinicaltrials.gov page where it should state if the trial is complete, tabulating data, or still recruiting.  Is the trial at a location the patient can access?  Sites are located at the bottom of the page.  However, both these points are not always up to date.  A trial may already be closed or new sites may have opened up.

5.  My biggest recommendation:  If you are remotely interested in ANY trial…even if access would be difficult, even if you think you may have an exclusion….CALL!!!!  It never hurts to ask and you may even learn about a new trial option that is even better for you when you talk to the trial coordinator.

Hope that helps a bit.  Good luck.  Celeste

Hey Julie,

Sorry you are having to ponder this…but it is a really good question.  Choosing my trial was pretty easy.  There weren't many options back in 2010!!!!  I looked first at a vaccine trial at Vanderbilt.  To be honest, it was more the way I was treated and how the trial was being "sold", as though it was a used car, that caused me to walk away.  Though in fact, there was little prior data to support the use of the particular vaccine.  However, it turned out to be a good decision, because the trial was canceled a year or so later as the control arm of patients NOT getting the vaccine were doing better than those who did.

The Nivolumab (Opdivo) trial I participated in caught my husband's attention intially because it did include vaccines!  Back then, vaccines were the "ta-dah" that was going to take care of melanoma!!!  (I still hope that someday they will!!) Ipi was not approved.  Immunotherapy was NOT on everybody's lips. BRAF inhibitors were in trials and stories of miracles were making the news…but still not FDA approved.  So…..I was accepted into the first arm, lowest dose of my Phase 1, nivo/with vaccine melanoma trial.  It lasted 2 1/2 years.  And I am still here, though not all my fellow ratties are.  We learned in 2013 that the peptide vaccines did absolutely NOTHING to help us….oh, well…hopefully nobody else will have to endure those 6 painful injections every 2 weeks.

Luckily, today, things are much different.  There are many more melanoma trials available…which is good.  But now that ipi, anti-PD1 and the BRAF inhibitors are FDA approved and available and many more folks with melanoma have taken them, making exclusions to trial participation very complicated.  Additionally, many trials these days are combo's….trials that pair all kinds of things, but very often immunotherapy (ipi, pembro or nivo) or BRAFi with some other drug…anything from IDO inhibitors, JAK inhibitors, intralesional therapies…etc.

PHASE.  An important thing to know.  Phase 1 trials are actually called dosing/safety trials.  EVERYBODY gets the drug.  What's being tested is how much a person can take without growing three heads…and hopefully some info is gleaned about the lower range of the dose that can stil solicit a response.  Also, this is an early trial in a drug's adventure into humans, so often, less data is out there about the drug in question.  Phase 2 trials are efficacy trials.  Here things get tricky because one arm may well be placebo as researchers try to determine how well the drug/therapy in question really works.  Phase 3 trials are comparison trials.  In the best case scenario, which is rare, the drug/therapy goes head to head with a similar drug.  It would have been very excellent to see this done comparing nivo to pembro in the early days.  It wasn't.  Now, it is pretty much a mute point since so many patients have taken them both, in trials and out, we are pretty clear that they are equivalent.  Today, a great trial would put the three main intralesionals one against the other….but I digress.  Sadly, in Phase 3 trials, the desired therapy is often compared to a lesser, undesireable one….say for instance…interferon vs Keytruda.

I have helped many folks find trials.  Here's how I look at them for others.

1.  What drug has the patient already had?  No need to spend a great deal of time on a trial you are excluded from.  Same with other disease processes that the patient may also have.  As well as tumor burden or location….as those can be inclusion/exclusion points as well.

2.  What is the data showing about the drugs being studied?  I work really hard to learn whatever the existing data is showing about that particular drug.  The earlier phase of the trial, the harder data is to find.

3.  What is the patient's tolerance of risk?  This can apply to Phase 1 and the "grow the heads" scenario or to Phase 2/3 trials in relation to getting the "bad arm".

4.  Availability. Is the trial open? This info should be listed at the top of the clinicaltrials.gov page where it should state if the trial is complete, tabulating data, or still recruiting.  Is the trial at a location the patient can access?  Sites are located at the bottom of the page.  However, both these points are not always up to date.  A trial may already be closed or new sites may have opened up.

5.  My biggest recommendation:  If you are remotely interested in ANY trial…even if access would be difficult, even if you think you may have an exclusion….CALL!!!!  It never hurts to ask and you may even learn about a new trial option that is even better for you when you talk to the trial coordinator.

Hope that helps a bit.  Good luck.  Celeste

Hi Julie, you have been given great advice by Josh, Brian and Celeste!!! I don't have much to add in the way of answering your questions, you are at a point where going to see the best and leaning on their expertise is probably the best way to go. I see that you have gone in the past to the Angeles Clinic, that would have been one place that I would have suggested going. If you have the time and want to get an idea of how the landscape has been changing as far as options go, then take a look at these two videos with Dr. Omid Hamid from the Angeles clinic. The first one is from 2014 and showes all the future posibilities and the second one is more current with more advanced data. I also follow Dr. Omid Hamid on twitter and try to follow the links to all his presentations. Best Wishes in your journey!!!Ed  https://www.youtube.com/watch?v=UKwuLmhT3Is  https://www.youtube.com/watch?v=10nUgi5R9UE

Hi Julie, you have been given great advice by Josh, Brian and Celeste!!! I don't have much to add in the way of answering your questions, you are at a point where going to see the best and leaning on their expertise is probably the best way to go. I see that you have gone in the past to the Angeles Clinic, that would have been one place that I would have suggested going. If you have the time and want to get an idea of how the landscape has been changing as far as options go, then take a look at these two videos with Dr. Omid Hamid from the Angeles clinic. The first one is from 2014 and showes all the future posibilities and the second one is more current with more advanced data. I also follow Dr. Omid Hamid on twitter and try to follow the links to all his presentations. Best Wishes in your journey!!!Ed  https://www.youtube.com/watch?v=UKwuLmhT3Is  https://www.youtube.com/watch?v=10nUgi5R9UE

Hi Julie, you have been given great advice by Josh, Brian and Celeste!!! I don't have much to add in the way of answering your questions, you are at a point where going to see the best and leaning on their expertise is probably the best way to go. I see that you have gone in the past to the Angeles Clinic, that would have been one place that I would have suggested going. If you have the time and want to get an idea of how the landscape has been changing as far as options go, then take a look at these two videos with Dr. Omid Hamid from the Angeles clinic. The first one is from 2014 and showes all the future posibilities and the second one is more current with more advanced data. I also follow Dr. Omid Hamid on twitter and try to follow the links to all his presentations. Best Wishes in your journey!!!Ed  https://www.youtube.com/watch?v=UKwuLmhT3Is  https://www.youtube.com/watch?v=10nUgi5R9UE