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Nivo/Ipi Combo Side Effects

Forums General Melanoma Community Nivo/Ipi Combo Side Effects

  • Post
    G-Samsa
    Participant

      I thought this might be interesting for others on this path.  I am nearing the final scheduled trial treatments and have had little difficulty tolerating them.  My most recent scan showed, amid all other stable or reduced tumors, two new less defined spots in my lungs.  The Drs. felt that while new melanoma could not be ruled out, it was more likely a reaction to the drugs.  You may have seen that there was an important paper presented at ASCO on the serious side effects to the lungs from the combo (translates to high mortality)  The course of action was to skip treatment and schedule an interim scan (4weeks). It's hard to for me to skip a treatment since I believe  this has been a life raft—you forget how powerful the drugs are and that the things they set in motion can build, and that you sometimes have to let go and hope you can swim.  Don't know whether anyone else has had this experience, so I thought I'd put it out there to stimulate awareness.

       

    Viewing 11 reply threads
    • Replies
        ed williams
        Participant

          I have been on the study of the two drugs since Jan.2014 but my study is double blind where I don't know if I am getting Ipi or Nivolumab or both. I have also had no strong side effects other than fatigue which is a small price to pay. My two lung tumors both reduced in size at first scan (12 weeks) then have remained stable since. Most of the literature that I have read suggest that early tumor regression suggest that I am getting the PD-1 drug. I am considered a partial responder at this point. Ct scans every 6 weeks is the BMS requirement for the study. My understanding is that there are about 1000 people on this study from BMS ( CA209-067, OCREB #13-027). I would love to hear from others that are on the study. Thanks for getting the conversation started G-Samsa, and I happy to hear that you are doing well. I hope your life raft becomes a coast guard rescue with a long,healthy and happy Life to follow. Ed

          ed williams
          Participant

            I have been on the study of the two drugs since Jan.2014 but my study is double blind where I don't know if I am getting Ipi or Nivolumab or both. I have also had no strong side effects other than fatigue which is a small price to pay. My two lung tumors both reduced in size at first scan (12 weeks) then have remained stable since. Most of the literature that I have read suggest that early tumor regression suggest that I am getting the PD-1 drug. I am considered a partial responder at this point. Ct scans every 6 weeks is the BMS requirement for the study. My understanding is that there are about 1000 people on this study from BMS ( CA209-067, OCREB #13-027). I would love to hear from others that are on the study. Thanks for getting the conversation started G-Samsa, and I happy to hear that you are doing well. I hope your life raft becomes a coast guard rescue with a long,healthy and happy Life to follow. Ed

            ed williams
            Participant

              I have been on the study of the two drugs since Jan.2014 but my study is double blind where I don't know if I am getting Ipi or Nivolumab or both. I have also had no strong side effects other than fatigue which is a small price to pay. My two lung tumors both reduced in size at first scan (12 weeks) then have remained stable since. Most of the literature that I have read suggest that early tumor regression suggest that I am getting the PD-1 drug. I am considered a partial responder at this point. Ct scans every 6 weeks is the BMS requirement for the study. My understanding is that there are about 1000 people on this study from BMS ( CA209-067, OCREB #13-027). I would love to hear from others that are on the study. Thanks for getting the conversation started G-Samsa, and I happy to hear that you are doing well. I hope your life raft becomes a coast guard rescue with a long,healthy and happy Life to follow. Ed

                Globetrotter
                Participant

                  Hi Ed … like you, i have been on the bms checkmate 067 trial since jan'14 and NED since aug'14 … an amazing result (and with few/no side effects) !!! I'm still in the trial but considering if and when to exit ?!? What is your current status ?

                  and for other patients on checkmate 067 who like me is a complete responder, what are your considerations related to leaving the trial ???

                   

                  best regards

                  Claus (from Denmark)

                  Globetrotter
                  Participant

                    Hi Ed … like you, i have been on the bms checkmate 067 trial since jan'14 and NED since aug'14 … an amazing result (and with few/no side effects) !!! I'm still in the trial but considering if and when to exit ?!? What is your current status ?

                    and for other patients on checkmate 067 who like me is a complete responder, what are your considerations related to leaving the trial ???

                     

                    best regards

                    Claus (from Denmark)

                    Globetrotter
                    Participant

                      Hi Ed … like you, i have been on the bms checkmate 067 trial since jan'14 and NED since aug'14 … an amazing result (and with few/no side effects) !!! I'm still in the trial but considering if and when to exit ?!? What is your current status ?

                      and for other patients on checkmate 067 who like me is a complete responder, what are your considerations related to leaving the trial ???

                       

                      best regards

                      Claus (from Denmark)

                    BrianP
                    Participant

                      Thanks for starting this thread G-Samsa.  That's very interesting.  I had not heard about that study at ASCO. I see my Dr. next Wednesday for an infusion so I'll be sure to ask him about that and in the meantime I'm going to see if I can track it down. I just past the one year mark on my ipi/nivo sequential trial.  Other than a hypophysitis side effect and lung mets developing while in the ipi portion of the phase, my side effects have been minimal on Nivo with results similar to what Ed posted.  The comment about "high mortality" due to this side effect is surprising because I wasn't aware of any side effect induced deaths on the drug.  Look forward to seeing the discussion on this thread.

                      Brian

                      BrianP
                      Participant

                        Thanks for starting this thread G-Samsa.  That's very interesting.  I had not heard about that study at ASCO. I see my Dr. next Wednesday for an infusion so I'll be sure to ask him about that and in the meantime I'm going to see if I can track it down. I just past the one year mark on my ipi/nivo sequential trial.  Other than a hypophysitis side effect and lung mets developing while in the ipi portion of the phase, my side effects have been minimal on Nivo with results similar to what Ed posted.  The comment about "high mortality" due to this side effect is surprising because I wasn't aware of any side effect induced deaths on the drug.  Look forward to seeing the discussion on this thread.

                        Brian

                          BrianP
                          Participant

                            I take that back, I knew there have been some deaths due to severe colitis but I wasn't aware of any deaths from this type of side effect.

                            BrianP
                            Participant

                              I take that back, I knew there have been some deaths due to severe colitis but I wasn't aware of any deaths from this type of side effect.

                              Bubbles
                              Participant

                                Hey to Brian and the rest of you….I posted some of the ASCO data (along with some slides) on the ipi/nivo combo as well as anti-PD1 in a July 13, 2014, blog post. There is also some discussion between Weber and Ribas about the combo and side effects from their "pretty darn impressive chat" posted on June 13, 2014….for those of you who are interested.  I wish you all minimal side effects and great results!

                                celeste

                                Bubbles
                                Participant

                                  Hey to Brian and the rest of you….I posted some of the ASCO data (along with some slides) on the ipi/nivo combo as well as anti-PD1 in a July 13, 2014, blog post. There is also some discussion between Weber and Ribas about the combo and side effects from their "pretty darn impressive chat" posted on June 13, 2014….for those of you who are interested.  I wish you all minimal side effects and great results!

                                  celeste

                                  Bubbles
                                  Participant

                                    Hey to Brian and the rest of you….I posted some of the ASCO data (along with some slides) on the ipi/nivo combo as well as anti-PD1 in a July 13, 2014, blog post. There is also some discussion between Weber and Ribas about the combo and side effects from their "pretty darn impressive chat" posted on June 13, 2014….for those of you who are interested.  I wish you all minimal side effects and great results!

                                    celeste

                                    BrianP
                                    Participant

                                      I take that back, I knew there have been some deaths due to severe colitis but I wasn't aware of any deaths from this type of side effect.

                                    BrianP
                                    Participant

                                      Thanks for starting this thread G-Samsa.  That's very interesting.  I had not heard about that study at ASCO. I see my Dr. next Wednesday for an infusion so I'll be sure to ask him about that and in the meantime I'm going to see if I can track it down. I just past the one year mark on my ipi/nivo sequential trial.  Other than a hypophysitis side effect and lung mets developing while in the ipi portion of the phase, my side effects have been minimal on Nivo with results similar to what Ed posted.  The comment about "high mortality" due to this side effect is surprising because I wasn't aware of any side effect induced deaths on the drug.  Look forward to seeing the discussion on this thread.

                                      Brian

                                      kalisama
                                      Participant

                                        Just so I'm on the same page… this is a  study combining Pd-1 and Yurvoy? 

                                        Thanks in advance,
                                        kali

                                        kalisama
                                        Participant

                                          Just so I'm on the same page… this is a  study combining Pd-1 and Yurvoy? 

                                          Thanks in advance,
                                          kali

                                          kalisama
                                          Participant

                                            Just so I'm on the same page… this is a  study combining Pd-1 and Yurvoy? 

                                            Thanks in advance,
                                            kali

                                            dvd
                                            Participant

                                              I started the double-blind ipi/nivo combination January 2014. The known drug was ipi at 3mg/kg, the unknown was a placebo or nivo at 1mg/kg. My tumor load was significant with mets on scalp, in neck & jaw, multiple lung lesions, vertebrae and lower leg (both soft tissue and bone). I completed the series of four combo infusions over three months when PET/CT showed NED. Although blinded, my oncologist is convinced I had the nivo rather than placebo because he had never seen such a complete and rapid response. Before starting the "maintenance" phase of the trial with bi-weekly infusions of nivo or placebo, my liver enzymes spiked (although I was without symptoms) to >10X normal so I was disqualified for continuation of infusions in the trial. A course of steroids brought my liver enzymes back to normal within about 6 weeks. My most recent CT scan follow up last week continues NED and the oncologist is requesting the trial allow me to stretch out the CT interval from every 6 weeks to every 3 months. During the course of treatment I had minimal side effects, limited to itching and a couple of weeks of fatigue.

                                              dvd
                                              Participant

                                                I started the double-blind ipi/nivo combination January 2014. The known drug was ipi at 3mg/kg, the unknown was a placebo or nivo at 1mg/kg. My tumor load was significant with mets on scalp, in neck & jaw, multiple lung lesions, vertebrae and lower leg (both soft tissue and bone). I completed the series of four combo infusions over three months when PET/CT showed NED. Although blinded, my oncologist is convinced I had the nivo rather than placebo because he had never seen such a complete and rapid response. Before starting the "maintenance" phase of the trial with bi-weekly infusions of nivo or placebo, my liver enzymes spiked (although I was without symptoms) to >10X normal so I was disqualified for continuation of infusions in the trial. A course of steroids brought my liver enzymes back to normal within about 6 weeks. My most recent CT scan follow up last week continues NED and the oncologist is requesting the trial allow me to stretch out the CT interval from every 6 weeks to every 3 months. During the course of treatment I had minimal side effects, limited to itching and a couple of weeks of fatigue.

                                                dvd
                                                Participant

                                                  I started the double-blind ipi/nivo combination January 2014. The known drug was ipi at 3mg/kg, the unknown was a placebo or nivo at 1mg/kg. My tumor load was significant with mets on scalp, in neck & jaw, multiple lung lesions, vertebrae and lower leg (both soft tissue and bone). I completed the series of four combo infusions over three months when PET/CT showed NED. Although blinded, my oncologist is convinced I had the nivo rather than placebo because he had never seen such a complete and rapid response. Before starting the "maintenance" phase of the trial with bi-weekly infusions of nivo or placebo, my liver enzymes spiked (although I was without symptoms) to >10X normal so I was disqualified for continuation of infusions in the trial. A course of steroids brought my liver enzymes back to normal within about 6 weeks. My most recent CT scan follow up last week continues NED and the oncologist is requesting the trial allow me to stretch out the CT interval from every 6 weeks to every 3 months. During the course of treatment I had minimal side effects, limited to itching and a couple of weeks of fatigue.

                                                    ed williams
                                                    Participant

                                                      Did you record any of the liver # at that time of spike?  I have been following my own #'s lately, something to do while I am getting my bi- weekly treatment. Normal ALT ( Alanine enzyme) range is between 17 – 63.  AST(Aspartate enzyme) normal range is 15- 37. These are Canadian enzyme level standards. My Alt goes up and down between 70 and 90, and my Ast range in the normal range most of the time, it has jumped up as high as 71 in early June. I was wondering at what # do they cut a person off the study? I also had the inching during the first few weeks, it then went away.  Glad to here that you are in the Ned category. Ed

                                                      ed williams
                                                      Participant

                                                        Did you record any of the liver # at that time of spike?  I have been following my own #'s lately, something to do while I am getting my bi- weekly treatment. Normal ALT ( Alanine enzyme) range is between 17 – 63.  AST(Aspartate enzyme) normal range is 15- 37. These are Canadian enzyme level standards. My Alt goes up and down between 70 and 90, and my Ast range in the normal range most of the time, it has jumped up as high as 71 in early June. I was wondering at what # do they cut a person off the study? I also had the inching during the first few weeks, it then went away.  Glad to here that you are in the Ned category. Ed

                                                        ed williams
                                                        Participant

                                                          Did you record any of the liver # at that time of spike?  I have been following my own #'s lately, something to do while I am getting my bi- weekly treatment. Normal ALT ( Alanine enzyme) range is between 17 – 63.  AST(Aspartate enzyme) normal range is 15- 37. These are Canadian enzyme level standards. My Alt goes up and down between 70 and 90, and my Ast range in the normal range most of the time, it has jumped up as high as 71 in early June. I was wondering at what # do they cut a person off the study? I also had the inching during the first few weeks, it then went away.  Glad to here that you are in the Ned category. Ed

                                                          dvd
                                                          Participant

                                                            Lab normals here are different: ALT 0-36 U/L and AST 10-40 U/L. My ALT topped out slightly over 400 and AST maxed at around 250. I believe the definition of a Level 4 Adverse Reaction was defined as >4X lab normal high and, if I remember correctly, any Level 4 Adverse Reaction disqualifies for continuation with infusions.

                                                            dvd
                                                            Participant

                                                              Lab normals here are different: ALT 0-36 U/L and AST 10-40 U/L. My ALT topped out slightly over 400 and AST maxed at around 250. I believe the definition of a Level 4 Adverse Reaction was defined as >4X lab normal high and, if I remember correctly, any Level 4 Adverse Reaction disqualifies for continuation with infusions.

                                                              dvd
                                                              Participant

                                                                Lab normals here are different: ALT 0-36 U/L and AST 10-40 U/L. My ALT topped out slightly over 400 and AST maxed at around 250. I believe the definition of a Level 4 Adverse Reaction was defined as >4X lab normal high and, if I remember correctly, any Level 4 Adverse Reaction disqualifies for continuation with infusions.

                                                                ed williams
                                                                Participant

                                                                  When the liver enzymes jumped, did you feel any change physically? Ed

                                                                  ed williams
                                                                  Participant

                                                                    When the liver enzymes jumped, did you feel any change physically? Ed

                                                                    dvd
                                                                    Participant

                                                                      No – I had no symptoms at all.

                                                                      dvd
                                                                      Participant

                                                                        No – I had no symptoms at all.

                                                                        dvd
                                                                        Participant

                                                                          No – I had no symptoms at all.

                                                                          ed williams
                                                                          Participant

                                                                            When the liver enzymes jumped, did you feel any change physically? Ed

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