› Forums › General Melanoma Community › Ipi/Nivo Combo
- This topic has 12 replies, 4 voices, and was last updated 8 years, 10 months ago by
Bennickliz.
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- June 22, 2015 at 1:27 pm
Is there anyone out there getting this combo without being on a trial? Can doctors prescribe this together since both drugs are FDA approved? I've had Ipi with slight growth and tolerated it well and want to get the combo. Thanks for any input.
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- June 22, 2015 at 4:57 pm
No, unfortunately they are not FDA-approved in combination, despite the fact that they are approved individually. There is expanded access to the combination therapy at specific cites – you can see at the link below. So even though it's not quite on trial, because the data shows such good outcomes, the FDA is allowing patients to get access to it (without having to worry about getting a placebo).
https://clinicaltrials.gov/show/NCT02186249
Right now, having already been treated with ipi and/or nivo/keytruda excludes you from access to the combination, however I think it wouldn't hurt to reach out and talk to them as you never know what take those actually giving the medications may have. Once they are FDA approved in combination, which should happen in the not-too-distant future (given that the FDA is allowing this expanded access), you may be able to try it even if you have been treated with one of them before.
One thing to keep in mind is that the combination therapy has significantly higher toxicity than either drug does individually. There is also some data indicating that if your tumor expresses the PD-L1 ligand, then nivolumab (or keytruda) alone may be as effective effective as in combination with ipi, but with much less toxicity. I really wish there were labs testing for this now, but there aren't any yet that I know of (outside of studies), so it's kind of a roll of the dice, but a relatively safer one.
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- June 22, 2015 at 4:57 pm
No, unfortunately they are not FDA-approved in combination, despite the fact that they are approved individually. There is expanded access to the combination therapy at specific cites – you can see at the link below. So even though it's not quite on trial, because the data shows such good outcomes, the FDA is allowing patients to get access to it (without having to worry about getting a placebo).
https://clinicaltrials.gov/show/NCT02186249
Right now, having already been treated with ipi and/or nivo/keytruda excludes you from access to the combination, however I think it wouldn't hurt to reach out and talk to them as you never know what take those actually giving the medications may have. Once they are FDA approved in combination, which should happen in the not-too-distant future (given that the FDA is allowing this expanded access), you may be able to try it even if you have been treated with one of them before.
One thing to keep in mind is that the combination therapy has significantly higher toxicity than either drug does individually. There is also some data indicating that if your tumor expresses the PD-L1 ligand, then nivolumab (or keytruda) alone may be as effective effective as in combination with ipi, but with much less toxicity. I really wish there were labs testing for this now, but there aren't any yet that I know of (outside of studies), so it's kind of a roll of the dice, but a relatively safer one.
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- June 22, 2015 at 4:57 pm
No, unfortunately they are not FDA-approved in combination, despite the fact that they are approved individually. There is expanded access to the combination therapy at specific cites – you can see at the link below. So even though it's not quite on trial, because the data shows such good outcomes, the FDA is allowing patients to get access to it (without having to worry about getting a placebo).
https://clinicaltrials.gov/show/NCT02186249
Right now, having already been treated with ipi and/or nivo/keytruda excludes you from access to the combination, however I think it wouldn't hurt to reach out and talk to them as you never know what take those actually giving the medications may have. Once they are FDA approved in combination, which should happen in the not-too-distant future (given that the FDA is allowing this expanded access), you may be able to try it even if you have been treated with one of them before.
One thing to keep in mind is that the combination therapy has significantly higher toxicity than either drug does individually. There is also some data indicating that if your tumor expresses the PD-L1 ligand, then nivolumab (or keytruda) alone may be as effective effective as in combination with ipi, but with much less toxicity. I really wish there were labs testing for this now, but there aren't any yet that I know of (outside of studies), so it's kind of a roll of the dice, but a relatively safer one.
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- June 22, 2015 at 9:28 pm
Hi Bennickliz, I looked for a your profile but you haven't made one yet. Just a couple of questions, one about your braf status? Second when did you do Ipi? The reason I ask is that you can get Nivolumab if you progress after taking ipi but you might have to do targeted therapy first depending on your braf status. Your oncologist should be talking to you about your options. Wishing you the best!!! Ed
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- June 22, 2015 at 10:45 pm
Actually you can get nivo or the other PD1 without doing other treatments, it has all changed now. there is a good discussion by a doctor from Mayo clinic on the combination of IPI/Nivo here: http://melanomainternational.org/2015/06/from-outside-the-halls-of-asco/#.VYiPgvlViko
Good luck to you!
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- June 22, 2015 at 11:01 pm
I did talk to my oncologist last week and he's is leaning towards a wait and see approach for 3 months and then get scanned. I have yet to do the PD 1 drugs. If the combo gets approved soon I would like to wait. My disease is for the most part either slow growing or the treatments I have had have benefited me. I did create a profile with treatment history. Thanks for all the input! Becky
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- June 22, 2015 at 11:01 pm
I did talk to my oncologist last week and he's is leaning towards a wait and see approach for 3 months and then get scanned. I have yet to do the PD 1 drugs. If the combo gets approved soon I would like to wait. My disease is for the most part either slow growing or the treatments I have had have benefited me. I did create a profile with treatment history. Thanks for all the input! Becky
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- June 22, 2015 at 11:01 pm
I did talk to my oncologist last week and he's is leaning towards a wait and see approach for 3 months and then get scanned. I have yet to do the PD 1 drugs. If the combo gets approved soon I would like to wait. My disease is for the most part either slow growing or the treatments I have had have benefited me. I did create a profile with treatment history. Thanks for all the input! Becky
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- June 22, 2015 at 10:45 pm
Actually you can get nivo or the other PD1 without doing other treatments, it has all changed now. there is a good discussion by a doctor from Mayo clinic on the combination of IPI/Nivo here: http://melanomainternational.org/2015/06/from-outside-the-halls-of-asco/#.VYiPgvlViko
Good luck to you!
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- June 22, 2015 at 10:45 pm
Actually you can get nivo or the other PD1 without doing other treatments, it has all changed now. there is a good discussion by a doctor from Mayo clinic on the combination of IPI/Nivo here: http://melanomainternational.org/2015/06/from-outside-the-halls-of-asco/#.VYiPgvlViko
Good luck to you!
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- June 22, 2015 at 9:28 pm
Hi Bennickliz, I looked for a your profile but you haven't made one yet. Just a couple of questions, one about your braf status? Second when did you do Ipi? The reason I ask is that you can get Nivolumab if you progress after taking ipi but you might have to do targeted therapy first depending on your braf status. Your oncologist should be talking to you about your options. Wishing you the best!!! Ed
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- June 22, 2015 at 9:28 pm
Hi Bennickliz, I looked for a your profile but you haven't made one yet. Just a couple of questions, one about your braf status? Second when did you do Ipi? The reason I ask is that you can get Nivolumab if you progress after taking ipi but you might have to do targeted therapy first depending on your braf status. Your oncologist should be talking to you about your options. Wishing you the best!!! Ed
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