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Stopping the Merck pd1 trial

Forums General Melanoma Community Stopping the Merck pd1 trial

  • Post
    killmel
    Participant

      Hi everyone

      I have been on Merck pd1clinical trial for over 3 yrs and I am a complete responder. I am going to discuss with my doctor on Tuesday, about stopping the drug & asking if I can stay on the Merck trial in a "Observation" status.

      I have read post of other Merck trial participants being on observation and remaining a participant in the trial. Unfortunately, I do not remember the specifics what the protocol is. Does my doctor just notify Merck that I am a complete responder and want to remain on the trial in"observation status"? I realize that there are no guarantees if I were to recur that Merck would let me back on the trial.

      I have a few questions: 1.)Once Merck agrees to put you on "observation" status, do you still have 2 more infusions before you stop the drug/trial? 2.)Do you still have to go in for regular scheduled blood work & doctor appts? 3.) Do you still have scans every 12 weeks. 4.) Is there any other protocol you have to follow to remain as an "Observation" trial participant.

      Thanks for replying to my post. I would love to hear from others that are doing the Merck PD1 trial that have been allowed to remain on the trial with an "observation" status

      Here is the trial I am on

      https://clinicaltrials.gov/ct2/show/NCT01295827

    Viewing 14 reply threads
    • Replies
        Speedster
        Participant

          Forgive me for not answering you question as I've only just entered the Nivo vs. Ipi trail from Bristol Meyers Squibb, yet you are NED, rihgt?  And when you entered you were what stage/condition? 

          I'm curious as the recent trial indicated Pembro beat Ipi hands down and I'm wonding how Pembro worked for you in case I'm on the Nivo (PD-1) leg of this trial or if I'm not and on Ipi (CTLA-4) leg.  Curious… 

          Speedster
          Participant

            Forgive me for not answering you question as I've only just entered the Nivo vs. Ipi trail from Bristol Meyers Squibb, yet you are NED, rihgt?  And when you entered you were what stage/condition? 

            I'm curious as the recent trial indicated Pembro beat Ipi hands down and I'm wonding how Pembro worked for you in case I'm on the Nivo (PD-1) leg of this trial or if I'm not and on Ipi (CTLA-4) leg.  Curious… 

            Speedster
            Participant

              Forgive me for not answering you question as I've only just entered the Nivo vs. Ipi trail from Bristol Meyers Squibb, yet you are NED, rihgt?  And when you entered you were what stage/condition? 

              I'm curious as the recent trial indicated Pembro beat Ipi hands down and I'm wonding how Pembro worked for you in case I'm on the Nivo (PD-1) leg of this trial or if I'm not and on Ipi (CTLA-4) leg.  Curious… 

              BrianP
              Participant

                Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                Good luck to you and congrats on 3 years!

                Brian

                BrianP
                Participant

                  Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                  Good luck to you and congrats on 3 years!

                  Brian

                  BrianP
                  Participant

                    Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                    Good luck to you and congrats on 3 years!

                    Brian

                    BrianP
                    Participant

                      Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                      Good luck to you and congrats on 3 years!

                      Brian

                      BrianP
                      Participant

                        Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                        Good luck to you and congrats on 3 years!

                        Brian

                        BrianP
                        Participant

                          Those are great questions and I hope someone can answer them but we may be anxiously awaiting you to answer those questions for us.  If you are a 3 year trial participant you are definitely leading the way for many of us anti PD-1 trial participants.  I'm in a IPI/Nivo combo trial that will hit the 2 year mark in August and I'm not being told anything to lead me to believe they intend to keep offering me the drug so I'm assuming I will be entering the observation period as well.  Unfortunately I'm not NED so if they won't allow me to stay on the drug in the trial I'm hoping to continue through my insurance off trial. 

                          Good luck to you and congrats on 3 years!

                          Brian

                          Bubbles
                          Participant

                            Brian is right…we are still waiting on ratties…like all of you…and me…to tell the tale.  I cannot say what the results for all of us will be.  Generally speaking…anti-PD1 patients have greater response rates than ipi patients.

                            http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

                            Though the blog post above is specifically about NED patients in both of the studies….but it is still the gist of research data for unresected patients as well.  But…duration of effect?  Anti-PD1 is still too new to know…

                            But, when you're looking at ipi, it is still pretty good:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/ipi-for-melanomathe-data-keeps-pouring.html

                            On the good side for all of us….more and more researchers feel that it is not necessary to take whatever med you respond to forever.  Durable responses are showing up with BRAFi after patients STOP the med: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/brafi-better-when-combined-with-or.html 

                            Weber has long contended that folks that respond don't need to take anti-PD1 forever.  Of course…the exact amount of time we DO need to take it remains unconfirmed.  For my part, with my ratties….http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

                            I remain:  139 months post melanoma diagnosis
                            59 months post Stage IV melanoma
                            53 months NED
                            51 months post start of nivo/Opdivo trial
                            21 months post my last infusion

                            I don't know if any of this helps.  But, I wish you all my best.  C

                            Bubbles
                            Participant

                              Brian is right…we are still waiting on ratties…like all of you…and me…to tell the tale.  I cannot say what the results for all of us will be.  Generally speaking…anti-PD1 patients have greater response rates than ipi patients.

                              http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

                              Though the blog post above is specifically about NED patients in both of the studies….but it is still the gist of research data for unresected patients as well.  But…duration of effect?  Anti-PD1 is still too new to know…

                              But, when you're looking at ipi, it is still pretty good:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/ipi-for-melanomathe-data-keeps-pouring.html

                              On the good side for all of us….more and more researchers feel that it is not necessary to take whatever med you respond to forever.  Durable responses are showing up with BRAFi after patients STOP the med: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/brafi-better-when-combined-with-or.html 

                              Weber has long contended that folks that respond don't need to take anti-PD1 forever.  Of course…the exact amount of time we DO need to take it remains unconfirmed.  For my part, with my ratties….http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

                              I remain:  139 months post melanoma diagnosis
                              59 months post Stage IV melanoma
                              53 months NED
                              51 months post start of nivo/Opdivo trial
                              21 months post my last infusion

                              I don't know if any of this helps.  But, I wish you all my best.  C

                              Bubbles
                              Participant

                                Brian is right…we are still waiting on ratties…like all of you…and me…to tell the tale.  I cannot say what the results for all of us will be.  Generally speaking…anti-PD1 patients have greater response rates than ipi patients.

                                http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html

                                Though the blog post above is specifically about NED patients in both of the studies….but it is still the gist of research data for unresected patients as well.  But…duration of effect?  Anti-PD1 is still too new to know…

                                But, when you're looking at ipi, it is still pretty good:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/ipi-for-melanomathe-data-keeps-pouring.html

                                On the good side for all of us….more and more researchers feel that it is not necessary to take whatever med you respond to forever.  Durable responses are showing up with BRAFi after patients STOP the med: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/brafi-better-when-combined-with-or.html 

                                Weber has long contended that folks that respond don't need to take anti-PD1 forever.  Of course…the exact amount of time we DO need to take it remains unconfirmed.  For my part, with my ratties….http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

                                I remain:  139 months post melanoma diagnosis
                                59 months post Stage IV melanoma
                                53 months NED
                                51 months post start of nivo/Opdivo trial
                                21 months post my last infusion

                                I don't know if any of this helps.  But, I wish you all my best.  C

                                sweetaugust
                                Participant

                                  I don't know the answers to your questions either.  But I am also curious to know more.

                                  Like…how many of you out there were on the Merck Pembro trial and decided to come off the trial just for the heck of it and how you guys are doing?  Have any of you relapsed?

                                  I have been on Merck's Pembro trial for 2.5 years so far and the doctors are planning on keeping me on the trial with no end date.  I am on the 10mg dose every 3 weeks for 30 minutes.   I've never been on any other treatments.  To the doctors I am considered a Partial Responder.  But in my mind…I feel like a Full Responder because there really is no evidence anywhere of anything going wrong.

                                  All my best to you, Laurie

                                  sweetaugust
                                  Participant

                                    I don't know the answers to your questions either.  But I am also curious to know more.

                                    Like…how many of you out there were on the Merck Pembro trial and decided to come off the trial just for the heck of it and how you guys are doing?  Have any of you relapsed?

                                    I have been on Merck's Pembro trial for 2.5 years so far and the doctors are planning on keeping me on the trial with no end date.  I am on the 10mg dose every 3 weeks for 30 minutes.   I've never been on any other treatments.  To the doctors I am considered a Partial Responder.  But in my mind…I feel like a Full Responder because there really is no evidence anywhere of anything going wrong.

                                    All my best to you, Laurie

                                    sweetaugust
                                    Participant

                                      I don't know the answers to your questions either.  But I am also curious to know more.

                                      Like…how many of you out there were on the Merck Pembro trial and decided to come off the trial just for the heck of it and how you guys are doing?  Have any of you relapsed?

                                      I have been on Merck's Pembro trial for 2.5 years so far and the doctors are planning on keeping me on the trial with no end date.  I am on the 10mg dose every 3 weeks for 30 minutes.   I've never been on any other treatments.  To the doctors I am considered a Partial Responder.  But in my mind…I feel like a Full Responder because there really is no evidence anywhere of anything going wrong.

                                      All my best to you, Laurie

                                  Viewing 14 reply threads
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