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Trail Study 13-105

Forums General Melanoma Community Trail Study 13-105

  • Post
    Jenine
    Participant

      Hello All,

      Has anyone participated in case study 13-105?  My husband is considering this as an option for treatment. From what I understand it has been in trail phase for 2 years but feedback is limited.  Thanks.

      Wishing everyone strength and good health♥️ 

      Jenine

    Viewing 2 reply threads
    • Replies
        debwray
        Participant

          Hi,

          With a bit of detective work I think the trial could be this one- especially as you are in Pittsurgh.

          NCT02112032 

          Treatment of Advanced Melanoma With MK-3475 and Peginterferon

          Its a dose safety escalation trial – with small numers of participants.

          Mk 3475 is keytruda/pemrolizumab or pembro for short…loads of info about this drug here and elsewhere.

          I think you already know about interferon/ sylatron

          Trial is small scale 32 participants.

          What stage is your husband at please ? What needs targetting ? Any info on previous treatments ? Braf positive etc ?

          What other treatments have been offered / are under consideration ?

          Think we need a bit more info to be able to contribute meaningfully but would generally prefer a later phase trial to a phase 1 trial .

          Will look out for your reply

          Deb

           

           

            Jenine
            Participant

              Hi Deb,

              I think you know more about the trial than I do…thanks.  My husband has 2 tumors, neck and sternum.  Waiting for braf results.  Honestly I don't even know what positive or negative braf means?  Any help you can offer would be great.   Bless you!!

              Thanks again,

              Jenine

              Bubbles
              Participant

                I'm sure Deb will answer you but here are some basics that might help regarding melanoma treatments:

                BRAF inhibitors (targeted therapy): work very well for folks with melanoma that test positive the the BRAF mutation. If you don't have it, they don't work. For BRAF positive patients, they can expect a 60-70 % response rate. BRAF inhibitors should always be combined with a MEK inhibitor. Obviously with the mutation the response rate is very impressive. However, for many the response lasts only 6-9 months, as tumors develop the ability to work around the treatment. On the other hand, there are those who have been maintained on these drugs for years. They are also valuable in decreasing tumor burden rapidly, and then quickly switching the patient to immunotherapy which can be slow in taking effect, but provides a more durable response.

                Immunotherapy: trigger the body's immune system to deal with melanoma. Therefore, side effects can be caused by an over active immune process. BRAF status is not thought to be a factor in response from most studies.

                Types of immunotherapy:

                IL2 – requires hospitalization, can be very toxic, has a complete response rate of about 5%. An older approach.

                Interferon – another older treatment, with minimal significant effect on progression free survivial, and NO effect on overall survival.

                Ipi (Yervoy)  – 15% response rate, but responses are proving durable. Immune related side effects can be significant.

                Anti-PD1 –  there are two basically equivalent products: nivolumab (opdivo) and pembrolizumab (keytruda). Both have about a 40% response rate…and ratties are proving responses durable here as well, with fewer immune related side effects compared to ipi.

                Ipi/nivo combo: provides the best response rate going with rates of 50% or more. Side effect profile much like ipi…due to ipi.

                Hope this helps. There is a great deal of information on all of these on my blog. Celeste

                Jenine
                Participant

                  Hi Celeste,

                  My husbands BRAF test came back negative.  Thank you for preparing me and helping me understand a things s little better.

                  With that being said clinical trial 13-105 is off the table.  Any suggestions for a new treatment path?  We go to the oncologist tomorrow. 

                  I visited your blog.  Your are absolutely adoreable and funny!  So grateful for you advise…

                  Bless you,

                  Jenine (Bill too)

                   

                   

                  Bubbles
                  Participant

                    Hi Jenine, 

                    Looking at your husband's treatments in the profile you created it appears that he has had only interferon and surgery. Also it would seem that he is now Stage IV, if I am understanding things properly. So….I think a very reasonable treatment at this time would be either one of the anti-PD1 products on their own…which are FDA approved for Stage IV patients, or the ipi/nivo combo. I, personally, would probably not choose to do ipi alone at this point as it has a lower response rate and more immune related side effects than anti-PD1. Additionally, studies have shown that when patients have ipi BEFORE anti-PD1, their response rates are decreased.

                    Here is one report demonstrating that (see #3 in this post…as well as the link with in that part):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                    I also saw that you are followed by Kirkwood. I think you shouod be aware that he is the King of interferon. Before 2010 when no other treatments for melanoma even existed other than IL2, that was acceptable. However, since the FDA approval of ipi and the BRAFi drugs in 2011, and later the anti-PD1 products, he has still really been pushing interferon…though as I noted above – it provides very little benefit in preventing melanoma progression and NONE whatsoever in helping survival. There are some studies in process combining interferon with other products, however, so far they have not demonstrated benefit greater than the product they have been paired with….but perhaps time will show a different tale.

                    Hope your appointment went well and your husband gains a viable treatmnent plan soon. I wish you well. Celeste

                    Bubbles
                    Participant

                      Hi Jenine, 

                      Looking at your husband's treatments in the profile you created it appears that he has had only interferon and surgery. Also it would seem that he is now Stage IV, if I am understanding things properly. So….I think a very reasonable treatment at this time would be either one of the anti-PD1 products on their own…which are FDA approved for Stage IV patients, or the ipi/nivo combo. I, personally, would probably not choose to do ipi alone at this point as it has a lower response rate and more immune related side effects than anti-PD1. Additionally, studies have shown that when patients have ipi BEFORE anti-PD1, their response rates are decreased.

                      Here is one report demonstrating that (see #3 in this post…as well as the link with in that part):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                      I also saw that you are followed by Kirkwood. I think you shouod be aware that he is the King of interferon. Before 2010 when no other treatments for melanoma even existed other than IL2, that was acceptable. However, since the FDA approval of ipi and the BRAFi drugs in 2011, and later the anti-PD1 products, he has still really been pushing interferon…though as I noted above – it provides very little benefit in preventing melanoma progression and NONE whatsoever in helping survival. There are some studies in process combining interferon with other products, however, so far they have not demonstrated benefit greater than the product they have been paired with….but perhaps time will show a different tale.

                      Hope your appointment went well and your husband gains a viable treatmnent plan soon. I wish you well. Celeste

                      Bubbles
                      Participant

                        Hi Jenine, 

                        Looking at your husband's treatments in the profile you created it appears that he has had only interferon and surgery. Also it would seem that he is now Stage IV, if I am understanding things properly. So….I think a very reasonable treatment at this time would be either one of the anti-PD1 products on their own…which are FDA approved for Stage IV patients, or the ipi/nivo combo. I, personally, would probably not choose to do ipi alone at this point as it has a lower response rate and more immune related side effects than anti-PD1. Additionally, studies have shown that when patients have ipi BEFORE anti-PD1, their response rates are decreased.

                        Here is one report demonstrating that (see #3 in this post…as well as the link with in that part):  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/05/asco-2016-three-anti-pd1-reports.html

                        I also saw that you are followed by Kirkwood. I think you shouod be aware that he is the King of interferon. Before 2010 when no other treatments for melanoma even existed other than IL2, that was acceptable. However, since the FDA approval of ipi and the BRAFi drugs in 2011, and later the anti-PD1 products, he has still really been pushing interferon…though as I noted above – it provides very little benefit in preventing melanoma progression and NONE whatsoever in helping survival. There are some studies in process combining interferon with other products, however, so far they have not demonstrated benefit greater than the product they have been paired with….but perhaps time will show a different tale.

                        Hope your appointment went well and your husband gains a viable treatmnent plan soon. I wish you well. Celeste

                        Jenine
                        Participant

                          Hi Celeste,

                          My husbands BRAF test came back negative.  Thank you for preparing me and helping me understand a things s little better.

                          With that being said clinical trial 13-105 is off the table.  Any suggestions for a new treatment path?  We go to the oncologist tomorrow. 

                          I visited your blog.  Your are absolutely adoreable and funny!  So grateful for you advise…

                          Bless you,

                          Jenine (Bill too)

                           

                           

                          Jenine
                          Participant

                            Hi Celeste,

                            My husbands BRAF test came back negative.  Thank you for preparing me and helping me understand a things s little better.

                            With that being said clinical trial 13-105 is off the table.  Any suggestions for a new treatment path?  We go to the oncologist tomorrow. 

                            I visited your blog.  Your are absolutely adoreable and funny!  So grateful for you advise…

                            Bless you,

                            Jenine (Bill too)

                             

                             

                            Bubbles
                            Participant

                              I'm sure Deb will answer you but here are some basics that might help regarding melanoma treatments:

                              BRAF inhibitors (targeted therapy): work very well for folks with melanoma that test positive the the BRAF mutation. If you don't have it, they don't work. For BRAF positive patients, they can expect a 60-70 % response rate. BRAF inhibitors should always be combined with a MEK inhibitor. Obviously with the mutation the response rate is very impressive. However, for many the response lasts only 6-9 months, as tumors develop the ability to work around the treatment. On the other hand, there are those who have been maintained on these drugs for years. They are also valuable in decreasing tumor burden rapidly, and then quickly switching the patient to immunotherapy which can be slow in taking effect, but provides a more durable response.

                              Immunotherapy: trigger the body's immune system to deal with melanoma. Therefore, side effects can be caused by an over active immune process. BRAF status is not thought to be a factor in response from most studies.

                              Types of immunotherapy:

                              IL2 – requires hospitalization, can be very toxic, has a complete response rate of about 5%. An older approach.

                              Interferon – another older treatment, with minimal significant effect on progression free survivial, and NO effect on overall survival.

                              Ipi (Yervoy)  – 15% response rate, but responses are proving durable. Immune related side effects can be significant.

                              Anti-PD1 –  there are two basically equivalent products: nivolumab (opdivo) and pembrolizumab (keytruda). Both have about a 40% response rate…and ratties are proving responses durable here as well, with fewer immune related side effects compared to ipi.

                              Ipi/nivo combo: provides the best response rate going with rates of 50% or more. Side effect profile much like ipi…due to ipi.

                              Hope this helps. There is a great deal of information on all of these on my blog. Celeste

                              Bubbles
                              Participant

                                I'm sure Deb will answer you but here are some basics that might help regarding melanoma treatments:

                                BRAF inhibitors (targeted therapy): work very well for folks with melanoma that test positive the the BRAF mutation. If you don't have it, they don't work. For BRAF positive patients, they can expect a 60-70 % response rate. BRAF inhibitors should always be combined with a MEK inhibitor. Obviously with the mutation the response rate is very impressive. However, for many the response lasts only 6-9 months, as tumors develop the ability to work around the treatment. On the other hand, there are those who have been maintained on these drugs for years. They are also valuable in decreasing tumor burden rapidly, and then quickly switching the patient to immunotherapy which can be slow in taking effect, but provides a more durable response.

                                Immunotherapy: trigger the body's immune system to deal with melanoma. Therefore, side effects can be caused by an over active immune process. BRAF status is not thought to be a factor in response from most studies.

                                Types of immunotherapy:

                                IL2 – requires hospitalization, can be very toxic, has a complete response rate of about 5%. An older approach.

                                Interferon – another older treatment, with minimal significant effect on progression free survivial, and NO effect on overall survival.

                                Ipi (Yervoy)  – 15% response rate, but responses are proving durable. Immune related side effects can be significant.

                                Anti-PD1 –  there are two basically equivalent products: nivolumab (opdivo) and pembrolizumab (keytruda). Both have about a 40% response rate…and ratties are proving responses durable here as well, with fewer immune related side effects compared to ipi.

                                Ipi/nivo combo: provides the best response rate going with rates of 50% or more. Side effect profile much like ipi…due to ipi.

                                Hope this helps. There is a great deal of information on all of these on my blog. Celeste

                                Jenine
                                Participant

                                  Hi Deb,

                                  I think you know more about the trial than I do…thanks.  My husband has 2 tumors, neck and sternum.  Waiting for braf results.  Honestly I don't even know what positive or negative braf means?  Any help you can offer would be great.   Bless you!!

                                  Thanks again,

                                  Jenine

                                  Jenine
                                  Participant

                                    Hi Deb,

                                    I think you know more about the trial than I do…thanks.  My husband has 2 tumors, neck and sternum.  Waiting for braf results.  Honestly I don't even know what positive or negative braf means?  Any help you can offer would be great.   Bless you!!

                                    Thanks again,

                                    Jenine

                                  debwray
                                  Participant

                                    Hi,

                                    With a bit of detective work I think the trial could be this one- especially as you are in Pittsurgh.

                                    NCT02112032 

                                    Treatment of Advanced Melanoma With MK-3475 and Peginterferon

                                    Its a dose safety escalation trial – with small numers of participants.

                                    Mk 3475 is keytruda/pemrolizumab or pembro for short…loads of info about this drug here and elsewhere.

                                    I think you already know about interferon/ sylatron

                                    Trial is small scale 32 participants.

                                    What stage is your husband at please ? What needs targetting ? Any info on previous treatments ? Braf positive etc ?

                                    What other treatments have been offered / are under consideration ?

                                    Think we need a bit more info to be able to contribute meaningfully but would generally prefer a later phase trial to a phase 1 trial .

                                    Will look out for your reply

                                    Deb

                                     

                                     

                                    debwray
                                    Participant

                                      Hi,

                                      With a bit of detective work I think the trial could be this one- especially as you are in Pittsurgh.

                                      NCT02112032 

                                      Treatment of Advanced Melanoma With MK-3475 and Peginterferon

                                      Its a dose safety escalation trial – with small numers of participants.

                                      Mk 3475 is keytruda/pemrolizumab or pembro for short…loads of info about this drug here and elsewhere.

                                      I think you already know about interferon/ sylatron

                                      Trial is small scale 32 participants.

                                      What stage is your husband at please ? What needs targetting ? Any info on previous treatments ? Braf positive etc ?

                                      What other treatments have been offered / are under consideration ?

                                      Think we need a bit more info to be able to contribute meaningfully but would generally prefer a later phase trial to a phase 1 trial .

                                      Will look out for your reply

                                      Deb

                                       

                                       

                                  Viewing 2 reply threads
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