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For those doing well on a Nivolumab Trial
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For those doing well on a Nivolumab Trial

› Forums › General Melanoma Community › For those doing well on a Nivolumab Trial

  • Post
    • October 18, 2014 at 1:28 am
    BrianP
    Participant

      I wanted to share this in the event someone else on here finds themselves in a similar situation as a friend of mine recently.  My friend is about 16 months into a 2 year clinical trial for nivolumab.  He achieved a NED status about 4 to 6 months ago.  About a week ago he went in for a regular infusion and got a big surprise. Right before he was heading to the infusion center the clinical trial coordinator came in and told him he was being taken off Nivolumab effective immediately.  Apparently in the protocol there is the following statement, "Discontinuation Due to Confirmed Complete Response:  Subjects with a CR continue to receive study therapy until response confirmation or for an additional 2 cycles (whichever is longer) and then enter the follow-up period."  Being none to pleased with this "surprise" my friend, along with the staff at UVA, appealed to BMS and got them to reverse their decision primarily on the argument that the quote above did not match the paperwork my friend had signed.

      I'm curious if this foreshadows what BMS's actions will be at the end of the 2 years for most participants.  From Laurie's post about her trial it seems like Merck may have a different view than BMS.  Time will tell. 

      Brian

       

    Viewing 5 reply threads
    • Replies
        • October 18, 2014 at 3:20 am
        Marianne quinn
        Participant

          Wow. That sucks

          • October 18, 2014 at 3:20 am
          Marianne quinn
          Participant

            Wow. That sucks

            • October 18, 2014 at 3:20 am
            Marianne quinn
            Participant

              Wow. That sucks

              • October 18, 2014 at 4:48 am
              Bubbles
              Participant

                Wow, Brian. That is pretty crazy! First and foremost, when in a clinical trial…you AND the drug company AND the institution AND researcher must abide by it. Meaning…BMS doesn't get to weasle out of the two full years they agreed to…the patient doesn't get to stay in the trial if they progress, if they sign on with another trial, get surgery, etc…if the trial agreement forbids it. That being said, the clinical trial process is certainly weighted much more heavily toward the institution, researchers and companies involved. I have lost count on the number of "new" protocols I have had to sign in my one, same trial…because the doc and/or BMS wanted to test for something, wanted to add another cohort, etc. This is NOT something the patient gets to do! It would never fly for me to walk in with a 20 plus page document and say, "Here, boys! Sign page 28 and initial here, here and here!" I have had many rants about same on my blog, in person at Moffitt, in emails…you name it! 

                On the good side. At least the folks taking care of your friend came to their senses and saw that they could not get out of their OWN protocol if the patient did not agree. One other bit of good news….hopefully….is that the researchers at Moffitt are of the opinion that my 2 1/2 years spent on Nivo was overkill. (No pun intended!) That a certain amount of drug satuates the system and it will either help you or it won't and just giving more drug will not make the outcome or duration of effect any different.  In that same vein, they feel that the "no end point other than progression" that Merck (and they give this drug as well) is not necessary.  My thoughts now…but never ending the drug could be quite the money maker, now couldn't it? Now, exactly how long the drug SHOULD be administered has yet to be definitively proven. I guess that's just one more thing your friend and ratties like myself will be demonstrating…eventually.

                "Do not go gentle into that good night. Rage, rage against they dying of the light."

                Hang in there my friends! Love, c

                 

                  • October 18, 2014 at 11:12 pm
                  BrianP
                  Participant

                    Celeste,

                    I think BMS acquiesced in this case because they know they were in the wrong.  I know these protocols are much longer then the 20 to 30 pages of the consent forms we sign but to leave something as important as this out of the consent form was a pretty big oversight.  My suspicion is that BMS would love to show that the drug doesn't need the full 2 year treatment for some patients perhaps to gain some favor with the FDA/insurance companies during the approval process.  I don't have an inkling of how that process works but I would think being able to show this data might help.

                    I hope the good folks at Moffit are right.  To me it makes sense for NED folks but I'm still not sure for the folks like me who still have stable tumors.  I just don't have a real good feeling about coming off the drug with those bad boys still hanging out.

                    Brian

                    • October 19, 2014 at 1:05 am
                    Bubbles
                    Participant

                      I know exactly what you mean, Brian.  I felt pretty weird getting no additional meds after 2 1/2 years, even though I was NED.  Oh, the life of a rattie!  I also agree that a shorter duration of administration with equivalent or better effect and duration of effect is exactly what BMS would like to prove so they can work it into their FDA approval.  However, it takes a bit of time to do that…and just making it end cause you want to….is not going to cut it….as BMS apparently had to admit in this case.  Pretty crazy stuff.  These sorts of issues are what make clinical trials particularly challenging for patients to negotiate.  AND….all those pages…written in legaleze…are a lot to take in when a patient is sick and frightened.  Being a rattie in a clinical trial…then helping others figure out their trials…has been an eye opening experience for me to say the least!!

                      Hope you're having a great weekend!  C

                      • October 19, 2014 at 1:05 am
                      Bubbles
                      Participant

                        I know exactly what you mean, Brian.  I felt pretty weird getting no additional meds after 2 1/2 years, even though I was NED.  Oh, the life of a rattie!  I also agree that a shorter duration of administration with equivalent or better effect and duration of effect is exactly what BMS would like to prove so they can work it into their FDA approval.  However, it takes a bit of time to do that…and just making it end cause you want to….is not going to cut it….as BMS apparently had to admit in this case.  Pretty crazy stuff.  These sorts of issues are what make clinical trials particularly challenging for patients to negotiate.  AND….all those pages…written in legaleze…are a lot to take in when a patient is sick and frightened.  Being a rattie in a clinical trial…then helping others figure out their trials…has been an eye opening experience for me to say the least!!

                        Hope you're having a great weekend!  C

                        • October 19, 2014 at 1:05 am
                        Bubbles
                        Participant

                          I know exactly what you mean, Brian.  I felt pretty weird getting no additional meds after 2 1/2 years, even though I was NED.  Oh, the life of a rattie!  I also agree that a shorter duration of administration with equivalent or better effect and duration of effect is exactly what BMS would like to prove so they can work it into their FDA approval.  However, it takes a bit of time to do that…and just making it end cause you want to….is not going to cut it….as BMS apparently had to admit in this case.  Pretty crazy stuff.  These sorts of issues are what make clinical trials particularly challenging for patients to negotiate.  AND….all those pages…written in legaleze…are a lot to take in when a patient is sick and frightened.  Being a rattie in a clinical trial…then helping others figure out their trials…has been an eye opening experience for me to say the least!!

                          Hope you're having a great weekend!  C

                          • October 20, 2014 at 11:44 am
                          G-Samsa
                          Participant

                            You think there might be a medical concern here?  I've been having a late blooming reaction to Nivo.   My doctors have indicated that this is not uncommon near the end of treatment– and that they've seen a patient with a pretty severe reaction after the last treatment, even though there were no prior episodes…. If the patient is NED, maybe the thought is not to rev the engine while it's humming? 

                            I am heartbroken — that my last treatments were scrubbed— bu then if my body can only achieve stable — I don't want to push it over the edge.

                             

                            • October 20, 2014 at 11:44 am
                            G-Samsa
                            Participant

                              You think there might be a medical concern here?  I've been having a late blooming reaction to Nivo.   My doctors have indicated that this is not uncommon near the end of treatment– and that they've seen a patient with a pretty severe reaction after the last treatment, even though there were no prior episodes…. If the patient is NED, maybe the thought is not to rev the engine while it's humming? 

                              I am heartbroken — that my last treatments were scrubbed— bu then if my body can only achieve stable — I don't want to push it over the edge.

                               

                              • October 20, 2014 at 4:08 pm
                              sweetaugust
                              Participant

                                Very interesting Brian!  I know there are many different trials out there and each of them are trying to learn different aspects about the drugs interaction with the human body.  How often to administer the drug, and how much of the drug to give being big important factors.  I know my arm of the trial is all about how much is too much really.  All the patients in my study were trying to help the doctors figure out what is the right dosing.  And I was given the arm with the highest dose possible, 10mg, at an interval of once every 3 weeks, for two years. 

                                So maybe that is why my Merck trial has now changed to a "no end date" for treatment.  Maybe different patients in my trial have had different clauses added to their contract.  Meaning, while I was changed to "no end date," maybe others in my trial are still ending at 2 years.  I had only asked my doctors about me…not about all the other patients in my arm of the trial.

                                And since my metastatic melanoma was identified and biopsied in a lymph node, my lymph node will obviously not just up and disappear completely.  Even if all cancer is dead in there, the node will still remain in my body…and it would have to shrink down to .5cm for them to consider it a complete response, or NED.  But that is not likely to happen because the tumor blew up last year and now has scar tissue on it that will make it almost impossible for it to go down to a complete response.

                                Also for me, four to five months into treatment, Merck wanted to take me off the trial because my node was still agressively growing, but I didn't come off of it because I was thinking that maybe my body just needed some more time for the drug to work.  I ended up being right.  So for me, even though the contract stated that I must come off the drug if the disease kept progressing, they still kept me on it.  So there must be wiggle room in there.

                                All my best, Laurie

                                • October 20, 2014 at 4:08 pm
                                sweetaugust
                                Participant

                                  Very interesting Brian!  I know there are many different trials out there and each of them are trying to learn different aspects about the drugs interaction with the human body.  How often to administer the drug, and how much of the drug to give being big important factors.  I know my arm of the trial is all about how much is too much really.  All the patients in my study were trying to help the doctors figure out what is the right dosing.  And I was given the arm with the highest dose possible, 10mg, at an interval of once every 3 weeks, for two years. 

                                  So maybe that is why my Merck trial has now changed to a "no end date" for treatment.  Maybe different patients in my trial have had different clauses added to their contract.  Meaning, while I was changed to "no end date," maybe others in my trial are still ending at 2 years.  I had only asked my doctors about me…not about all the other patients in my arm of the trial.

                                  And since my metastatic melanoma was identified and biopsied in a lymph node, my lymph node will obviously not just up and disappear completely.  Even if all cancer is dead in there, the node will still remain in my body…and it would have to shrink down to .5cm for them to consider it a complete response, or NED.  But that is not likely to happen because the tumor blew up last year and now has scar tissue on it that will make it almost impossible for it to go down to a complete response.

                                  Also for me, four to five months into treatment, Merck wanted to take me off the trial because my node was still agressively growing, but I didn't come off of it because I was thinking that maybe my body just needed some more time for the drug to work.  I ended up being right.  So for me, even though the contract stated that I must come off the drug if the disease kept progressing, they still kept me on it.  So there must be wiggle room in there.

                                  All my best, Laurie

                                  • October 20, 2014 at 4:08 pm
                                  sweetaugust
                                  Participant

                                    Very interesting Brian!  I know there are many different trials out there and each of them are trying to learn different aspects about the drugs interaction with the human body.  How often to administer the drug, and how much of the drug to give being big important factors.  I know my arm of the trial is all about how much is too much really.  All the patients in my study were trying to help the doctors figure out what is the right dosing.  And I was given the arm with the highest dose possible, 10mg, at an interval of once every 3 weeks, for two years. 

                                    So maybe that is why my Merck trial has now changed to a "no end date" for treatment.  Maybe different patients in my trial have had different clauses added to their contract.  Meaning, while I was changed to "no end date," maybe others in my trial are still ending at 2 years.  I had only asked my doctors about me…not about all the other patients in my arm of the trial.

                                    And since my metastatic melanoma was identified and biopsied in a lymph node, my lymph node will obviously not just up and disappear completely.  Even if all cancer is dead in there, the node will still remain in my body…and it would have to shrink down to .5cm for them to consider it a complete response, or NED.  But that is not likely to happen because the tumor blew up last year and now has scar tissue on it that will make it almost impossible for it to go down to a complete response.

                                    Also for me, four to five months into treatment, Merck wanted to take me off the trial because my node was still agressively growing, but I didn't come off of it because I was thinking that maybe my body just needed some more time for the drug to work.  I ended up being right.  So for me, even though the contract stated that I must come off the drug if the disease kept progressing, they still kept me on it.  So there must be wiggle room in there.

                                    All my best, Laurie

                                    • October 20, 2014 at 7:01 pm
                                    BrianP
                                    Participant

                                      G-Samsa,

                                      Sorry the last treatments were scrubbed.  Hopefully time will tell that you didn't need them.  I find a little comfort in some information published lately that shows folks who responded well and come off the drug respond well again if treatment is restarted.  I even saw one example of a RCC patient (I think it was RCC) who responded better the second time than the first.  Thanks for the heads up on the end of treatment side effects.  It's easy to let your guard down over time.  You forget how much in a sense that you really are playing with fire.

                                      Brian

                                      • October 20, 2014 at 7:01 pm
                                      BrianP
                                      Participant

                                        G-Samsa,

                                        Sorry the last treatments were scrubbed.  Hopefully time will tell that you didn't need them.  I find a little comfort in some information published lately that shows folks who responded well and come off the drug respond well again if treatment is restarted.  I even saw one example of a RCC patient (I think it was RCC) who responded better the second time than the first.  Thanks for the heads up on the end of treatment side effects.  It's easy to let your guard down over time.  You forget how much in a sense that you really are playing with fire.

                                        Brian

                                        • October 20, 2014 at 7:01 pm
                                        BrianP
                                        Participant

                                          G-Samsa,

                                          Sorry the last treatments were scrubbed.  Hopefully time will tell that you didn't need them.  I find a little comfort in some information published lately that shows folks who responded well and come off the drug respond well again if treatment is restarted.  I even saw one example of a RCC patient (I think it was RCC) who responded better the second time than the first.  Thanks for the heads up on the end of treatment side effects.  It's easy to let your guard down over time.  You forget how much in a sense that you really are playing with fire.

                                          Brian

                                          • October 20, 2014 at 11:44 am
                                          G-Samsa
                                          Participant

                                            You think there might be a medical concern here?  I've been having a late blooming reaction to Nivo.   My doctors have indicated that this is not uncommon near the end of treatment– and that they've seen a patient with a pretty severe reaction after the last treatment, even though there were no prior episodes…. If the patient is NED, maybe the thought is not to rev the engine while it's humming? 

                                            I am heartbroken — that my last treatments were scrubbed— bu then if my body can only achieve stable — I don't want to push it over the edge.

                                             

                                            • October 18, 2014 at 11:12 pm
                                            BrianP
                                            Participant

                                              Celeste,

                                              I think BMS acquiesced in this case because they know they were in the wrong.  I know these protocols are much longer then the 20 to 30 pages of the consent forms we sign but to leave something as important as this out of the consent form was a pretty big oversight.  My suspicion is that BMS would love to show that the drug doesn't need the full 2 year treatment for some patients perhaps to gain some favor with the FDA/insurance companies during the approval process.  I don't have an inkling of how that process works but I would think being able to show this data might help.

                                              I hope the good folks at Moffit are right.  To me it makes sense for NED folks but I'm still not sure for the folks like me who still have stable tumors.  I just don't have a real good feeling about coming off the drug with those bad boys still hanging out.

                                              Brian

                                              • October 18, 2014 at 11:12 pm
                                              BrianP
                                              Participant

                                                Celeste,

                                                I think BMS acquiesced in this case because they know they were in the wrong.  I know these protocols are much longer then the 20 to 30 pages of the consent forms we sign but to leave something as important as this out of the consent form was a pretty big oversight.  My suspicion is that BMS would love to show that the drug doesn't need the full 2 year treatment for some patients perhaps to gain some favor with the FDA/insurance companies during the approval process.  I don't have an inkling of how that process works but I would think being able to show this data might help.

                                                I hope the good folks at Moffit are right.  To me it makes sense for NED folks but I'm still not sure for the folks like me who still have stable tumors.  I just don't have a real good feeling about coming off the drug with those bad boys still hanging out.

                                                Brian

                                              • October 18, 2014 at 4:48 am
                                              Bubbles
                                              Participant

                                                Wow, Brian. That is pretty crazy! First and foremost, when in a clinical trial…you AND the drug company AND the institution AND researcher must abide by it. Meaning…BMS doesn't get to weasle out of the two full years they agreed to…the patient doesn't get to stay in the trial if they progress, if they sign on with another trial, get surgery, etc…if the trial agreement forbids it. That being said, the clinical trial process is certainly weighted much more heavily toward the institution, researchers and companies involved. I have lost count on the number of "new" protocols I have had to sign in my one, same trial…because the doc and/or BMS wanted to test for something, wanted to add another cohort, etc. This is NOT something the patient gets to do! It would never fly for me to walk in with a 20 plus page document and say, "Here, boys! Sign page 28 and initial here, here and here!" I have had many rants about same on my blog, in person at Moffitt, in emails…you name it! 

                                                On the good side. At least the folks taking care of your friend came to their senses and saw that they could not get out of their OWN protocol if the patient did not agree. One other bit of good news….hopefully….is that the researchers at Moffitt are of the opinion that my 2 1/2 years spent on Nivo was overkill. (No pun intended!) That a certain amount of drug satuates the system and it will either help you or it won't and just giving more drug will not make the outcome or duration of effect any different.  In that same vein, they feel that the "no end point other than progression" that Merck (and they give this drug as well) is not necessary.  My thoughts now…but never ending the drug could be quite the money maker, now couldn't it? Now, exactly how long the drug SHOULD be administered has yet to be definitively proven. I guess that's just one more thing your friend and ratties like myself will be demonstrating…eventually.

                                                "Do not go gentle into that good night. Rage, rage against they dying of the light."

                                                Hang in there my friends! Love, c

                                                 

                                                • October 18, 2014 at 4:48 am
                                                Bubbles
                                                Participant

                                                  Wow, Brian. That is pretty crazy! First and foremost, when in a clinical trial…you AND the drug company AND the institution AND researcher must abide by it. Meaning…BMS doesn't get to weasle out of the two full years they agreed to…the patient doesn't get to stay in the trial if they progress, if they sign on with another trial, get surgery, etc…if the trial agreement forbids it. That being said, the clinical trial process is certainly weighted much more heavily toward the institution, researchers and companies involved. I have lost count on the number of "new" protocols I have had to sign in my one, same trial…because the doc and/or BMS wanted to test for something, wanted to add another cohort, etc. This is NOT something the patient gets to do! It would never fly for me to walk in with a 20 plus page document and say, "Here, boys! Sign page 28 and initial here, here and here!" I have had many rants about same on my blog, in person at Moffitt, in emails…you name it! 

                                                  On the good side. At least the folks taking care of your friend came to their senses and saw that they could not get out of their OWN protocol if the patient did not agree. One other bit of good news….hopefully….is that the researchers at Moffitt are of the opinion that my 2 1/2 years spent on Nivo was overkill. (No pun intended!) That a certain amount of drug satuates the system and it will either help you or it won't and just giving more drug will not make the outcome or duration of effect any different.  In that same vein, they feel that the "no end point other than progression" that Merck (and they give this drug as well) is not necessary.  My thoughts now…but never ending the drug could be quite the money maker, now couldn't it? Now, exactly how long the drug SHOULD be administered has yet to be definitively proven. I guess that's just one more thing your friend and ratties like myself will be demonstrating…eventually.

                                                  "Do not go gentle into that good night. Rage, rage against they dying of the light."

                                                  Hang in there my friends! Love, c

                                                   

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