› Forums › General Melanoma Community › Clinical Trial for 3c – need help understanding
- This topic has 15 replies, 3 voices, and was last updated 10 years ago by
Bubbles.
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- June 10, 2015 at 3:16 pm
Can someone give me any input on this trial:
https://clinicaltrials.gov/ct2/show/NCT02129075?term=melanoma&recr=Open&rank=6
It's one of the very few that I can qualify for, but I'm not familiar with these vaccines. I'm fully resected (Feb. this year) right axilla, CLND of 15 nodes, 3-4 positive with matting. NED so far with scans next month.
I'm looking for some insight from someone with more knowledge than I regarding vaccines.
Thanks!
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- June 10, 2015 at 6:12 pm
Hi Brewgirl68, I took a look at the study and then looked up the phase 1 study on Gov clincial trials. I would want to get a look at the data from the phase one trial to see how people did and what kind of side effect they experienced. It looks like the phase one was run by a Dr. Patrick Ott from Harvard connected to Dana- Farber hospital in Boston. I read some stuff a couple of years ago about this hospital and I think they were trying to use the persons tumor to work with the vaccine then put in under the skin using a special kind of plastic disc. If it is the same vaccine the study was being funded by the Wyss Institute in connection with Harvard and Dana-Farber hospital. At ASCO 2015 there was some buzz about T-vec which uses the herpes virus to get a Immune responce. You need to have lesions that they can inject with the T-vec for it to be able to work. That being said, Immunotherapy is showing the best result with Melanoma, and I don't think there has been much success in the past with Vaccines. I watched a video with Dr. Antoni Ribas of UCLA on YOu tube titled " Melanoma Immunotherapy: What's next for Patients" It was made in May of 2015 and talks about the various choices for patients today. Dr. Ribas is one of the leading names in Immunotherapy especially drugs that target the Pd-1 pathway. He talks about vaccines towards the end of the video. Hope this is of some help! Ed
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- June 10, 2015 at 6:12 pm
Hi Brewgirl68, I took a look at the study and then looked up the phase 1 study on Gov clincial trials. I would want to get a look at the data from the phase one trial to see how people did and what kind of side effect they experienced. It looks like the phase one was run by a Dr. Patrick Ott from Harvard connected to Dana- Farber hospital in Boston. I read some stuff a couple of years ago about this hospital and I think they were trying to use the persons tumor to work with the vaccine then put in under the skin using a special kind of plastic disc. If it is the same vaccine the study was being funded by the Wyss Institute in connection with Harvard and Dana-Farber hospital. At ASCO 2015 there was some buzz about T-vec which uses the herpes virus to get a Immune responce. You need to have lesions that they can inject with the T-vec for it to be able to work. That being said, Immunotherapy is showing the best result with Melanoma, and I don't think there has been much success in the past with Vaccines. I watched a video with Dr. Antoni Ribas of UCLA on YOu tube titled " Melanoma Immunotherapy: What's next for Patients" It was made in May of 2015 and talks about the various choices for patients today. Dr. Ribas is one of the leading names in Immunotherapy especially drugs that target the Pd-1 pathway. He talks about vaccines towards the end of the video. Hope this is of some help! Ed
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- June 10, 2015 at 6:12 pm
Hi Brewgirl68, I took a look at the study and then looked up the phase 1 study on Gov clincial trials. I would want to get a look at the data from the phase one trial to see how people did and what kind of side effect they experienced. It looks like the phase one was run by a Dr. Patrick Ott from Harvard connected to Dana- Farber hospital in Boston. I read some stuff a couple of years ago about this hospital and I think they were trying to use the persons tumor to work with the vaccine then put in under the skin using a special kind of plastic disc. If it is the same vaccine the study was being funded by the Wyss Institute in connection with Harvard and Dana-Farber hospital. At ASCO 2015 there was some buzz about T-vec which uses the herpes virus to get a Immune responce. You need to have lesions that they can inject with the T-vec for it to be able to work. That being said, Immunotherapy is showing the best result with Melanoma, and I don't think there has been much success in the past with Vaccines. I watched a video with Dr. Antoni Ribas of UCLA on YOu tube titled " Melanoma Immunotherapy: What's next for Patients" It was made in May of 2015 and talks about the various choices for patients today. Dr. Ribas is one of the leading names in Immunotherapy especially drugs that target the Pd-1 pathway. He talks about vaccines towards the end of the video. Hope this is of some help! Ed
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- June 10, 2015 at 11:59 pm
Brewgirl,
Finding an NED trial is not easy, but you may have more options than you think. Here are some posts you may find helpful:
And I found all of these last year using the clinicaltrials.gov site entering "adjuvant melanoma" in the search bubble: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/09/studies-listed-as-adjuvants-for.html
I wish you well. Celeste
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- June 10, 2015 at 11:59 pm
Brewgirl,
Finding an NED trial is not easy, but you may have more options than you think. Here are some posts you may find helpful:
And I found all of these last year using the clinicaltrials.gov site entering "adjuvant melanoma" in the search bubble: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/09/studies-listed-as-adjuvants-for.html
I wish you well. Celeste
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- June 10, 2015 at 11:59 pm
Brewgirl,
Finding an NED trial is not easy, but you may have more options than you think. Here are some posts you may find helpful:
And I found all of these last year using the clinicaltrials.gov site entering "adjuvant melanoma" in the search bubble: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/09/studies-listed-as-adjuvants-for.html
I wish you well. Celeste
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- June 11, 2015 at 1:41 pm
Thank you, Ed and Celeste!
I did do a bit more research and there are two things that throw red flags for me…first, it's a vaccine trial and there has not been great response (that I can tell) and second, it's a Phase II study (I would be more comfortable with a Phase III). I found two more trials, but they are also vaccine and are both Phase I.
I'm can't qualify for the Ipi vs Nivo trial since you have to randomize within 12 weeks of resection. I was SO frustrated several weeks ago…I found the trial before it was officially recruiting, then called BMS to get info. The person that I spoke with in their clinical trial department gave me completely incorrect info and by the time I got the correct info I missed the window by about 1 week. Ugh.
I guess I will just wait (and cross my fingers) for another resected, BRAF negative, NED, IIIc, unknown primary trial…tall order to fill!
Best wishes to everyone 🙂
Sheila
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- June 11, 2015 at 1:56 pm
You are right finding an NED trial is not east. BRAFi trials are running..but… Did you look at this trial in particular? https://clinicaltrials.gov/ct2/show/NCT01176474
It is actually the one I started in 2010. At that time vaccines were being given along with Nivo. These particular vaccines did not work (We ratties proved that much!!!) so they are no longer being given and therefore the HLA typing is no longer required. It was been expanded and re-expanded such that I am no longer sure of exactly which part is still recruiting. When I started it….it was recruiting only Stage IV with a resected and non-resected arm. Now it has changed to include Stage III and has some ipi/nivo combo arms as well. When I started there was no stipulation regarding time past resection. I realize that may have changed as well. But, I would still contact Dr. Weber and/or the trial coordinator at Moffitt if you haven't and are at all interested.
Wishing you my best. c
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- June 11, 2015 at 1:56 pm
You are right finding an NED trial is not east. BRAFi trials are running..but… Did you look at this trial in particular? https://clinicaltrials.gov/ct2/show/NCT01176474
It is actually the one I started in 2010. At that time vaccines were being given along with Nivo. These particular vaccines did not work (We ratties proved that much!!!) so they are no longer being given and therefore the HLA typing is no longer required. It was been expanded and re-expanded such that I am no longer sure of exactly which part is still recruiting. When I started it….it was recruiting only Stage IV with a resected and non-resected arm. Now it has changed to include Stage III and has some ipi/nivo combo arms as well. When I started there was no stipulation regarding time past resection. I realize that may have changed as well. But, I would still contact Dr. Weber and/or the trial coordinator at Moffitt if you haven't and are at all interested.
Wishing you my best. c
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- June 11, 2015 at 1:56 pm
You are right finding an NED trial is not east. BRAFi trials are running..but… Did you look at this trial in particular? https://clinicaltrials.gov/ct2/show/NCT01176474
It is actually the one I started in 2010. At that time vaccines were being given along with Nivo. These particular vaccines did not work (We ratties proved that much!!!) so they are no longer being given and therefore the HLA typing is no longer required. It was been expanded and re-expanded such that I am no longer sure of exactly which part is still recruiting. When I started it….it was recruiting only Stage IV with a resected and non-resected arm. Now it has changed to include Stage III and has some ipi/nivo combo arms as well. When I started there was no stipulation regarding time past resection. I realize that may have changed as well. But, I would still contact Dr. Weber and/or the trial coordinator at Moffitt if you haven't and are at all interested.
Wishing you my best. c
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- June 11, 2015 at 1:41 pm
Thank you, Ed and Celeste!
I did do a bit more research and there are two things that throw red flags for me…first, it's a vaccine trial and there has not been great response (that I can tell) and second, it's a Phase II study (I would be more comfortable with a Phase III). I found two more trials, but they are also vaccine and are both Phase I.
I'm can't qualify for the Ipi vs Nivo trial since you have to randomize within 12 weeks of resection. I was SO frustrated several weeks ago…I found the trial before it was officially recruiting, then called BMS to get info. The person that I spoke with in their clinical trial department gave me completely incorrect info and by the time I got the correct info I missed the window by about 1 week. Ugh.
I guess I will just wait (and cross my fingers) for another resected, BRAF negative, NED, IIIc, unknown primary trial…tall order to fill!
Best wishes to everyone 🙂
Sheila
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- June 11, 2015 at 1:41 pm
Thank you, Ed and Celeste!
I did do a bit more research and there are two things that throw red flags for me…first, it's a vaccine trial and there has not been great response (that I can tell) and second, it's a Phase II study (I would be more comfortable with a Phase III). I found two more trials, but they are also vaccine and are both Phase I.
I'm can't qualify for the Ipi vs Nivo trial since you have to randomize within 12 weeks of resection. I was SO frustrated several weeks ago…I found the trial before it was officially recruiting, then called BMS to get info. The person that I spoke with in their clinical trial department gave me completely incorrect info and by the time I got the correct info I missed the window by about 1 week. Ugh.
I guess I will just wait (and cross my fingers) for another resected, BRAF negative, NED, IIIc, unknown primary trial…tall order to fill!
Best wishes to everyone 🙂
Sheila
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- June 11, 2015 at 2:09 pm
Also…this trial with pembro for resected "high risk Stage III" https://clinicaltrials.gov/ct2/show/NCT02362594?term=pembrolizumab+and+resected+melanoma&rank=1 is in process though not yet recruiting. It is Pembro vs placebo, however…so that is not so great. But it might be something to keep an eye on. c
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- June 11, 2015 at 2:09 pm
Also…this trial with pembro for resected "high risk Stage III" https://clinicaltrials.gov/ct2/show/NCT02362594?term=pembrolizumab+and+resected+melanoma&rank=1 is in process though not yet recruiting. It is Pembro vs placebo, however…so that is not so great. But it might be something to keep an eye on. c
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- June 11, 2015 at 2:09 pm
Also…this trial with pembro for resected "high risk Stage III" https://clinicaltrials.gov/ct2/show/NCT02362594?term=pembrolizumab+and+resected+melanoma&rank=1 is in process though not yet recruiting. It is Pembro vs placebo, however…so that is not so great. But it might be something to keep an eye on. c
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