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ipi and nivo EAP

Forums Mucosal Melanoma Community ipi and nivo EAP

  • Post
    mrf
    Keymaster

      BMS has launched an Expanded Access Protocol for the combination of ipi and nivo, their anti-CTLA4 and anti-PD1 drugs. Earlier this year both Merck and BMS opened EAP programs for the PD1 drugs alone.

      The combination of ipi and nivo has some very strong results. In one study, 88% of patients with metastatic melanoma were alive after two years. Side effects are a concern, with about 2/3 of paitents having Grade 3 or Grade 4 toxicities. The doctors involved with the study felt that these issues were rather easily managed.

      This was just announced this morning, so no sites are open yet. As we have seen, sometimes these sites do take a while to open.  For more information you can go to the EAP posting on clinicaltrials.gov.  

      Some details:

      –mucosal melanoma is included

      –must not have had prior treatment with ipi

      –brain mets are allowed, if MRI confirms no progression in 2 weeks

      I hope to have more information soon, but in the interim here is the link to the posting:

      http://clinicaltrials.gov/ct2/show/NCT02186249?term=nivolumab+melanoma&type=Expn&rank=1

       

      Tim–MRF

    Viewing 5 reply threads
    • Replies
        Bubbles
        Participant

          That's GREAT, Tim!  Thanks for getting the word out!  Celeste

          Bubbles
          Participant

            That's GREAT, Tim!  Thanks for getting the word out!  Celeste

              Cooper
              Participant

                Couple of problems, no previous treatments allowed and there are no locations yet.  The study was in a small group so I am not sure I would count on it yet with the side effects being really harsh.

                Thandster
                Participant

                  Wrong.  It certainly does not say NO TREATMENTS ALLOWED.  And any EAP is not available at sites THE DAY they announce it will be made available. 

                  Thandster
                  Participant

                    Wrong.  It certainly does not say NO TREATMENTS ALLOWED.  And any EAP is not available at sites THE DAY they announce it will be made available. 

                    Thandster
                    Participant

                      Wrong.  It certainly does not say NO TREATMENTS ALLOWED.  And any EAP is not available at sites THE DAY they announce it will be made available. 

                      BrianP
                      Participant

                        Cooper,

                        Why do you have to be so harsh with your responses?

                        It looks like the only disqualifier from prior treatments is Ipi.  That is good news.  Also good news if you are Braf Positive you don't have to have failed Braf treatment.

                        I hope the timeline is quick.  Tim mentioned 6 – 8 weeks on BMS's part in another post.  At my facility they have a board which also has to approve the treatment being administered at their facility.  Not sure if other facilities have the same requirement but I imagine they do.  This process can take weeks also.  Hopefully it can be done concurrent with the 6 to 8 weeks and not in addition to it. 

                        My WAG (Wild A*& Guess) is 2 months before first patient is treated but could be upwards of 4 months. 

                        I think this is absolutely fantastic news for the melanoma community.

                        Brian

                        BrianP
                        Participant

                          Cooper,

                          Why do you have to be so harsh with your responses?

                          It looks like the only disqualifier from prior treatments is Ipi.  That is good news.  Also good news if you are Braf Positive you don't have to have failed Braf treatment.

                          I hope the timeline is quick.  Tim mentioned 6 – 8 weeks on BMS's part in another post.  At my facility they have a board which also has to approve the treatment being administered at their facility.  Not sure if other facilities have the same requirement but I imagine they do.  This process can take weeks also.  Hopefully it can be done concurrent with the 6 to 8 weeks and not in addition to it. 

                          My WAG (Wild A*& Guess) is 2 months before first patient is treated but could be upwards of 4 months. 

                          I think this is absolutely fantastic news for the melanoma community.

                          Brian

                          Bubbles
                          Participant

                            Brian,

                            I just love you!  C

                            Bubbles
                            Participant

                              Brian,

                              I just love you!  C

                              Bubbles
                              Participant

                                Brian,

                                I just love you!  C

                                BrianP
                                Participant

                                  Cooper,

                                  Why do you have to be so harsh with your responses?

                                  It looks like the only disqualifier from prior treatments is Ipi.  That is good news.  Also good news if you are Braf Positive you don't have to have failed Braf treatment.

                                  I hope the timeline is quick.  Tim mentioned 6 – 8 weeks on BMS's part in another post.  At my facility they have a board which also has to approve the treatment being administered at their facility.  Not sure if other facilities have the same requirement but I imagine they do.  This process can take weeks also.  Hopefully it can be done concurrent with the 6 to 8 weeks and not in addition to it. 

                                  My WAG (Wild A*& Guess) is 2 months before first patient is treated but could be upwards of 4 months. 

                                  I think this is absolutely fantastic news for the melanoma community.

                                  Brian

                                  RJoeyB
                                  Participant

                                    [I also posted this in Tim's other update thread about this EAP, apologies for the double-post, just trying to be thorough…]

                                    Also remember that BMS has announced a separate EAP for nivolumab alone for patients who have already tried and failed ipilimumab.  I think it was announced in May and while details on locations have thus far been scarce, we're still in that 6-8 week period where they're still ramping things up, I assume.  Hopefully there will be more details about enrollment opportunities forthcoming very soon.
                                     
                                    Joe
                                     
                                    RJoeyB
                                    Participant

                                      [I also posted this in Tim's other update thread about this EAP, apologies for the double-post, just trying to be thorough…]

                                      Also remember that BMS has announced a separate EAP for nivolumab alone for patients who have already tried and failed ipilimumab.  I think it was announced in May and while details on locations have thus far been scarce, we're still in that 6-8 week period where they're still ramping things up, I assume.  Hopefully there will be more details about enrollment opportunities forthcoming very soon.
                                       
                                      Joe
                                       
                                      RJoeyB
                                      Participant

                                        [I also posted this in Tim's other update thread about this EAP, apologies for the double-post, just trying to be thorough…]

                                        Also remember that BMS has announced a separate EAP for nivolumab alone for patients who have already tried and failed ipilimumab.  I think it was announced in May and while details on locations have thus far been scarce, we're still in that 6-8 week period where they're still ramping things up, I assume.  Hopefully there will be more details about enrollment opportunities forthcoming very soon.
                                         
                                        Joe
                                         
                                        Cooper
                                        Participant

                                          Couple of problems, no previous treatments allowed and there are no locations yet.  The study was in a small group so I am not sure I would count on it yet with the side effects being really harsh.

                                          Cooper
                                          Participant

                                            Couple of problems, no previous treatments allowed and there are no locations yet.  The study was in a small group so I am not sure I would count on it yet with the side effects being really harsh.

                                          Bubbles
                                          Participant

                                            That's GREAT, Tim!  Thanks for getting the word out!  Celeste

                                            arthurjedi007
                                            Participant

                                              "Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)"

                                              So if you had ipi the FDA approved way (ie: not clinical study) you are not excluded then?

                                              arthurjedi007
                                              Participant

                                                "Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)"

                                                So if you had ipi the FDA approved way (ie: not clinical study) you are not excluded then?

                                                  Bubbles
                                                  Participant

                                                    Artie,

                                                    I fear no prior ipi at all will be allowed. Since in the "inclusion criteria" it states that patients must be ipi naive.  While the exclusions are difficult for many, I think I am most upset by the statement that, apparently, folks who never really got ipi or nivo because they were in the control arm of a study, can be excluded as well.  I'm hoping I'm wrong about that, but that is what it seems to say.

                                                    Best, celeste

                                                    Bubbles
                                                    Participant

                                                      Artie,

                                                      I fear no prior ipi at all will be allowed. Since in the "inclusion criteria" it states that patients must be ipi naive.  While the exclusions are difficult for many, I think I am most upset by the statement that, apparently, folks who never really got ipi or nivo because they were in the control arm of a study, can be excluded as well.  I'm hoping I'm wrong about that, but that is what it seems to say.

                                                      Best, celeste

                                                      RJoeyB
                                                      Participant

                                                        This isn't intended as a justification for BMS, only an observation.  Merck's MK-3475 pembrolizumab EAP has this in it's own exclusion criteria.  From:

                                                        Frequently Asked Questions about pembrolizumab U.S. Expanded Access Program
                                                         
                                                        Are patients from the control arms of any pembrolizumab studies eligible?
                                                        No, patients who were on the control arm of any pembrolizumab studies are not eligible to participate in the expanded access program.
                                                         
                                                        I can't say for certain the reasoning or if there is specific FDA regulation involved in making this decision, but I'm guessing that that thinking goes as follows…  these EAPs are being established because of the incredible results that are being observed in Phase II trials as well as yet-to-be-completed Phase III trials.  Final FDA approval won't be granted to any of these therapies until the Phase III trials are complete.  Even Merck's expected October approval won't be for pembro as a first-line therapy (at least prior ipi will be a condition).  Once that Phase III trial is done and submitted, the approval will then be revised and pembro can be a first-line therapy.  In the meantime, if patients in the control arms of existing therapies were all allowed to effectively cross over to the EAP, this would effectively end all of the Phase III testing.  And for patients who have had disease progression, they would need to "unblind" all the arms to determine who received what, also effectively ruining the study results.  There are some well-constructed studies that have crossovers built into them, but plenty that aren't.
                                                         
                                                        Again, not defending it in any way, I'm a four-year Stage IV fighter like many of you just trying to understand how these things work so I'm prepared to make the right decisions if/when the need arises.  Issues like this are ugly, even more so being so close to it, and I wish there were better answers.  
                                                         
                                                        Joe
                                                         
                                                         
                                                        RJoeyB
                                                        Participant

                                                          This isn't intended as a justification for BMS, only an observation.  Merck's MK-3475 pembrolizumab EAP has this in it's own exclusion criteria.  From:

                                                          Frequently Asked Questions about pembrolizumab U.S. Expanded Access Program
                                                           
                                                          Are patients from the control arms of any pembrolizumab studies eligible?
                                                          No, patients who were on the control arm of any pembrolizumab studies are not eligible to participate in the expanded access program.
                                                           
                                                          I can't say for certain the reasoning or if there is specific FDA regulation involved in making this decision, but I'm guessing that that thinking goes as follows…  these EAPs are being established because of the incredible results that are being observed in Phase II trials as well as yet-to-be-completed Phase III trials.  Final FDA approval won't be granted to any of these therapies until the Phase III trials are complete.  Even Merck's expected October approval won't be for pembro as a first-line therapy (at least prior ipi will be a condition).  Once that Phase III trial is done and submitted, the approval will then be revised and pembro can be a first-line therapy.  In the meantime, if patients in the control arms of existing therapies were all allowed to effectively cross over to the EAP, this would effectively end all of the Phase III testing.  And for patients who have had disease progression, they would need to "unblind" all the arms to determine who received what, also effectively ruining the study results.  There are some well-constructed studies that have crossovers built into them, but plenty that aren't.
                                                           
                                                          Again, not defending it in any way, I'm a four-year Stage IV fighter like many of you just trying to understand how these things work so I'm prepared to make the right decisions if/when the need arises.  Issues like this are ugly, even more so being so close to it, and I wish there were better answers.  
                                                           
                                                          Joe
                                                           
                                                           
                                                          arthurjedi007
                                                          Participant

                                                            Ok. Thanks Celeste and Joe. It doesn't chemically make sense to me. I would think if ctla-4 doesn't work because the mel cell has pd-1 blocking it. Then pd-1 doesn't work because the mel cell has recreated ctla-4 blocking it. Then doing both at once might work. I remember having that type of conversation with my local doctor when I was doing ipi. He seemed to agree with the logic. But who knows. I guess it all comes down to rules, regulations, side affects, money, etc. I'm counting on merck's eap pd1. I've had 3 doses so far but I don't want to get my hopes up too much yet because so many meds have failed me but the past 2 days the tumor on my skull is significantly smaller so I'm really encouraged by that. The big one on my shoulder and lymph node haven't shrank yet but are same visible size so I take that as good too.

                                                            arthurjedi007
                                                            Participant

                                                              Ok. Thanks Celeste and Joe. It doesn't chemically make sense to me. I would think if ctla-4 doesn't work because the mel cell has pd-1 blocking it. Then pd-1 doesn't work because the mel cell has recreated ctla-4 blocking it. Then doing both at once might work. I remember having that type of conversation with my local doctor when I was doing ipi. He seemed to agree with the logic. But who knows. I guess it all comes down to rules, regulations, side affects, money, etc. I'm counting on merck's eap pd1. I've had 3 doses so far but I don't want to get my hopes up too much yet because so many meds have failed me but the past 2 days the tumor on my skull is significantly smaller so I'm really encouraged by that. The big one on my shoulder and lymph node haven't shrank yet but are same visible size so I take that as good too.

                                                              arthurjedi007
                                                              Participant

                                                                Ok. Thanks Celeste and Joe. It doesn't chemically make sense to me. I would think if ctla-4 doesn't work because the mel cell has pd-1 blocking it. Then pd-1 doesn't work because the mel cell has recreated ctla-4 blocking it. Then doing both at once might work. I remember having that type of conversation with my local doctor when I was doing ipi. He seemed to agree with the logic. But who knows. I guess it all comes down to rules, regulations, side affects, money, etc. I'm counting on merck's eap pd1. I've had 3 doses so far but I don't want to get my hopes up too much yet because so many meds have failed me but the past 2 days the tumor on my skull is significantly smaller so I'm really encouraged by that. The big one on my shoulder and lymph node haven't shrank yet but are same visible size so I take that as good too.

                                                                RJoeyB
                                                                Participant

                                                                  This isn't intended as a justification for BMS, only an observation.  Merck's MK-3475 pembrolizumab EAP has this in it's own exclusion criteria.  From:

                                                                  Frequently Asked Questions about pembrolizumab U.S. Expanded Access Program
                                                                   
                                                                  Are patients from the control arms of any pembrolizumab studies eligible?
                                                                  No, patients who were on the control arm of any pembrolizumab studies are not eligible to participate in the expanded access program.
                                                                   
                                                                  I can't say for certain the reasoning or if there is specific FDA regulation involved in making this decision, but I'm guessing that that thinking goes as follows…  these EAPs are being established because of the incredible results that are being observed in Phase II trials as well as yet-to-be-completed Phase III trials.  Final FDA approval won't be granted to any of these therapies until the Phase III trials are complete.  Even Merck's expected October approval won't be for pembro as a first-line therapy (at least prior ipi will be a condition).  Once that Phase III trial is done and submitted, the approval will then be revised and pembro can be a first-line therapy.  In the meantime, if patients in the control arms of existing therapies were all allowed to effectively cross over to the EAP, this would effectively end all of the Phase III testing.  And for patients who have had disease progression, they would need to "unblind" all the arms to determine who received what, also effectively ruining the study results.  There are some well-constructed studies that have crossovers built into them, but plenty that aren't.
                                                                   
                                                                  Again, not defending it in any way, I'm a four-year Stage IV fighter like many of you just trying to understand how these things work so I'm prepared to make the right decisions if/when the need arises.  Issues like this are ugly, even more so being so close to it, and I wish there were better answers.  
                                                                   
                                                                  Joe
                                                                   
                                                                   
                                                                  Bubbles
                                                                  Participant

                                                                    Artie,

                                                                    I fear no prior ipi at all will be allowed. Since in the "inclusion criteria" it states that patients must be ipi naive.  While the exclusions are difficult for many, I think I am most upset by the statement that, apparently, folks who never really got ipi or nivo because they were in the control arm of a study, can be excluded as well.  I'm hoping I'm wrong about that, but that is what it seems to say.

                                                                    Best, celeste

                                                                  arthurjedi007
                                                                  Participant

                                                                    "Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)"

                                                                    So if you had ipi the FDA approved way (ie: not clinical study) you are not excluded then?

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