› Forums › General Melanoma Community › are there any combo Braf/Ipi trials out there yet?
- This topic has 24 replies, 6 voices, and was last updated 14 years, 2 months ago by
bcl.
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- September 19, 2010 at 5:40 pm
Cass is looking for a follow up to plx -I found this comment by Unite in the archives -does anyone know how close these combos are to trial?
Posted by Unite at 05:50 on Fri, Jul 23, 2010 [Show other posts by Unite]
Cass is looking for a follow up to plx -I found this comment by Unite in the archives -does anyone know how close these combos are to trial?
Posted by Unite at 05:50 on Fri, Jul 23, 2010 [Show other posts by Unite]
In Reply to: Re: confused about inhibitors by Tom posted at 06:07 on Thu, Jul 22, 2010
Mek inhibitors have worked in Braf inhibitor delayed failures. Try the MEK or ipi trials next. I think ipi and MEK or BRAf inhibitor combination will ultimately work for many patients
(BMY is developing a BRAF which will probably be tried with ipi or like drug). Ipi and chemo seems to also work for some patients but I am not seeing a lot of trials for this combo.
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- September 19, 2010 at 7:44 pm
The short answer is no, but this is one (obvious) approach that will be pursued. As is the case with a number of trials, the theory is to test one agent that has shown effectiveness and combine it with antother that has either shown effectiveness against melanoma or another cancer or potential effeciveness against melanoma. In my case, I am in a Trail involving Ipilimumab and Temador. Dr Keith Flaherty in Boston is among several researchers who is advocating a combined Ipi/BRAF Inhibitor Trial, but there several procedural, regularory, and economic hurdles to overcome. My best guess is that we will see such a trail after Ipi is approved, and perhaps in the next year or so.
Jim
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- September 19, 2010 at 7:44 pm
The short answer is no, but this is one (obvious) approach that will be pursued. As is the case with a number of trials, the theory is to test one agent that has shown effectiveness and combine it with antother that has either shown effectiveness against melanoma or another cancer or potential effeciveness against melanoma. In my case, I am in a Trail involving Ipilimumab and Temador. Dr Keith Flaherty in Boston is among several researchers who is advocating a combined Ipi/BRAF Inhibitor Trial, but there several procedural, regularory, and economic hurdles to overcome. My best guess is that we will see such a trail after Ipi is approved, and perhaps in the next year or so.
Jim
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- September 19, 2010 at 8:03 pm
Hi,
So happy to hear something about Cass. How is she doing??? Last posting if I remeber correctly, she was going to a brain met procedure. Hope it went well?? I thought that Cass did well on PLX 4032, why not just continue it??? Perhaps, she might want to consider IPI??? Has she considered IPI??
We all miss Cass, please let us know how she is doing??
Give her our Best!
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- September 19, 2010 at 8:03 pm
Hi,
So happy to hear something about Cass. How is she doing??? Last posting if I remeber correctly, she was going to a brain met procedure. Hope it went well?? I thought that Cass did well on PLX 4032, why not just continue it??? Perhaps, she might want to consider IPI??? Has she considered IPI??
We all miss Cass, please let us know how she is doing??
Give her our Best!
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- September 19, 2010 at 9:06 pm
I just found an article that mentions the MRF wanting to do a BRAF/IPI trial: "Dr. Schuchter said that the Melanoma Research Foundation is in the planning stages of a study that combines ipilimumab and PLX4032 in patients with metastatic melanoma." Doesn't mention timing, but seems this is the line of thinking.
http://www.medscape.com/viewarticle/727137. It is mentioned at the bottom of the article.
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- September 22, 2010 at 10:35 pm
MRF has established a consortium of top clinical researchers and top pre-clinical researchers for the specific purpose of conducting trials using combinations of drugs that are still in development. This is the hardest kind of trial to do because of regulatory issues, intellectual property, etc. Yet is also the most promising approach. We did this at the request of the research community, because they knew that no one institution could make this happen on its own.
We are currently reviewing seven different combination options–including PLX 4032 (BRAF) and ipi. We hope to start the first trials either late this year or early next year. This is a huge undertaking and carries a lot of risk, but we are compelled by the promise this holds for bringing new therapies to the clinical setting more quickly that could be done any other way.
Currently industry negotiates with several institutions to set up trials. This process of one-by-one negotiation can take up to two years. In other words, they have the drug, they believe it will work, but they spend two years negotiating agreements before they even begin the trial.
If we can establish a single global agreement that engages several different institutions then industry can negotiate that one agreement and get access to all the sites they need. This will shorten the process by a year or more. Of course, developing that agreement will be laborious and involve a lot of lawyers….
Tim–MRF
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- September 23, 2010 at 3:28 am
Keep up the good work Tim!
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- September 23, 2010 at 3:28 am
Keep up the good work Tim!
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- September 22, 2010 at 10:35 pm
MRF has established a consortium of top clinical researchers and top pre-clinical researchers for the specific purpose of conducting trials using combinations of drugs that are still in development. This is the hardest kind of trial to do because of regulatory issues, intellectual property, etc. Yet is also the most promising approach. We did this at the request of the research community, because they knew that no one institution could make this happen on its own.
We are currently reviewing seven different combination options–including PLX 4032 (BRAF) and ipi. We hope to start the first trials either late this year or early next year. This is a huge undertaking and carries a lot of risk, but we are compelled by the promise this holds for bringing new therapies to the clinical setting more quickly that could be done any other way.
Currently industry negotiates with several institutions to set up trials. This process of one-by-one negotiation can take up to two years. In other words, they have the drug, they believe it will work, but they spend two years negotiating agreements before they even begin the trial.
If we can establish a single global agreement that engages several different institutions then industry can negotiate that one agreement and get access to all the sites they need. This will shorten the process by a year or more. Of course, developing that agreement will be laborious and involve a lot of lawyers….
Tim–MRF
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- September 19, 2010 at 9:06 pm
I just found an article that mentions the MRF wanting to do a BRAF/IPI trial: "Dr. Schuchter said that the Melanoma Research Foundation is in the planning stages of a study that combines ipilimumab and PLX4032 in patients with metastatic melanoma." Doesn't mention timing, but seems this is the line of thinking.
http://www.medscape.com/viewarticle/727137. It is mentioned at the bottom of the article.
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- September 19, 2010 at 11:28 pm
I wonder what the scientific basis is for believing that Braf combos with ipi will work. My understanding is that Braf operates by shutting down a certain process which causes melanoma to keep growing. It seems that, once it ceases to shut that process down, (and this seems to happen), immunotherapy would be futile. It seems like the approach should be to improve the effectiveness of the Braf drugs, or develop more gene therapy.
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- September 22, 2010 at 10:29 pm
I wondered the same thing, and asked a couple of researchers about this. Here is what I took from those conversations.
BRAF is a targeted therapy drug and so it affects cells that are actively growing and dividing. "ipi" is an immunotherapy drug and as such will unmask the hidden tumor cells so the immune system can attack and destroy them.
Combining them means that the BRAF will knock down the tumor burden quickly and significantly, then ipi will allow the body to mop up any remaning dormant cells.
Tim–MRF
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- September 22, 2010 at 10:29 pm
I wondered the same thing, and asked a couple of researchers about this. Here is what I took from those conversations.
BRAF is a targeted therapy drug and so it affects cells that are actively growing and dividing. "ipi" is an immunotherapy drug and as such will unmask the hidden tumor cells so the immune system can attack and destroy them.
Combining them means that the BRAF will knock down the tumor burden quickly and significantly, then ipi will allow the body to mop up any remaning dormant cells.
Tim–MRF
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- September 19, 2010 at 11:28 pm
I wonder what the scientific basis is for believing that Braf combos with ipi will work. My understanding is that Braf operates by shutting down a certain process which causes melanoma to keep growing. It seems that, once it ceases to shut that process down, (and this seems to happen), immunotherapy would be futile. It seems like the approach should be to improve the effectiveness of the Braf drugs, or develop more gene therapy.
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- September 20, 2010 at 2:59 am
Further reading on the subject:
http://www.nytimes.com/2010/02/24/health/research/24trial.html?ref=target_cancer&pagewanted=all
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- September 20, 2010 at 2:59 am
Further reading on the subject:
http://www.nytimes.com/2010/02/24/health/research/24trial.html?ref=target_cancer&pagewanted=all
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