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Your precious advice on clinical trial – Stage 3 low dose ipi + nivo

Forums General Melanoma Community Your precious advice on clinical trial – Stage 3 low dose ipi + nivo

  • Post
    SOLE
    Participant

      I meet with my «new» oncologist later today and will discuss about this clinical trial

      https://clinicaltrials.gov/ct2/show/NCT02656706

      The beauty of this is, after talking to one of the lady responsible for it, it does not require CLND!

      And my platelet disorder could be accepted if everything else is fine according to her.

      It would require me to travel a lot from Montreal to Providence in the next 6 months but that is secondary at the moment since the other option I have here is… interferon!

      My questions to you

      1) Who pays for the drugs since I am a foreigner? Do you guys in the US pay anything at all for the drugs while on a clinical trial?

      2) What do clinicians conducting trials usually as of patients in terms of follow-up? It does not say anything here in terms of scans or blood work. Is it implied? I'm asking this because I want to know if it is at all feasible to be 7 driving hours (or 6 flight hours approx) away from the hospital.

      Your advice is deeply needed and any impressions or suggestions are welcome.

      I think I begin to understand what «being your own advocate» means…

    Viewing 8 reply threads
    • Replies
        Linny
        Participant

          I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

          While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

          When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

          Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

          Linny
          Participant

            I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

            While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

            When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

            Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

            Linny
            Participant

              I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

              While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

              When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

              Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

              debwray
              Participant

                First impression- looks like a good option.  No placebo !

                Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

                Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

                Scans- best guess three monthly. Details will be in trial invitation.

                Drugs co usually state will pay reasonable cost of travel- whatever that means.

                probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

                My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

                Good luck

                Deb

                 

                 

                  SOLE
                  Participant

                    Thank you Deb for this.

                    As I am not at all familiar with trials, you say that if I use PD-1 now in the form of nivo, I wont be able to use Keytruda later for example?

                    We dont have Nivo in Canada but Keytruda. That's why that trial seemed good to me. And we will likely never have the combo available as regular treatment, at least in Quebec. It is simply too expensive for our public provincial health system. 

                    About being pro active, with my existing condition of low platelets (40 000 detected by the machine last week but I did 63 000 just before my surgery on sept 9th.), I am in serious trouble for future clinical trials. My oncologist said to me that I would be in trouble using immunotherapy if platelets dont rise. 

                    Also saw my new derm today and she did two punch biopsies. 30 minutes later I was bleeding through the band aids like a pig. I should have told her to use cotton ball and hypafix… Came back home with a good portion of the back of my shirt soaked in blood. Took some large gauze and fixed the two punch biopsies with hypafix.

                    I hear you about the 6 months. But do all stage 4 trials demand a clear path for PD-1? Is nivo and keytruda treated the same when it comes to PD-1?

                    Also, I'm trying my luck with this trial despite my platelet condition. I will talk to the hospital nurse tomorrow. 

                    Wish me luck!

                    debwray
                    Participant

                      Yes be lucky !

                      Not saying you would deffo be barred BUT some trials demand no previous Immunotherapy or say no previous PD1 or say no previous immunotherapy in the previous 6 weeks – a washout period. It would differ by trial .. you could get a feel for it by looking at exclusion criteria .for stage iv melanoma trials on clinical trials.gov…… but this would only be needed if you progressed to stage iv . Nivo and keytruda are both PD1 drugs- but work in slightly different ways. Think it is not settled if it is worth trying them both in succession- but easier to argue for a new PD 1 rather than more of the same if treatment not successful. 

                      However, some folks have given up Keytruda as NED but are keeping that as an option if retreatment needed at a later date….and keytruda does seem to be marginally better than nivo as a sole agent at the current state of knowledge…

                      Just wanted to let you know that treatment with a drug may have implications for what might be available later. Like you , I wanted treatment at stage 3 in the hope of heading off stage iv… .

                      Platelets can be down for all sorts of reasons- mishandled sample is only one of a number. Think you said you had changed diet and gone vegan ? Are you sure you are getting enough iron and B12 on the new diet. Daughter is a vegan and this is one of my concerns .. although B12 stores should last for ages…

                      See what they say… and keeping lymph nodes with tiny traces doesn't seem a silly choice given the lack of evidence for CLND leading to better survival outcomes.

                      Best of wishes

                      Deb

                       

                       

                       

                       

                      debwray
                      Participant

                        Yes be lucky !

                        Not saying you would deffo be barred BUT some trials demand no previous Immunotherapy or say no previous PD1 or say no previous immunotherapy in the previous 6 weeks – a washout period. It would differ by trial .. you could get a feel for it by looking at exclusion criteria .for stage iv melanoma trials on clinical trials.gov…… but this would only be needed if you progressed to stage iv . Nivo and keytruda are both PD1 drugs- but work in slightly different ways. Think it is not settled if it is worth trying them both in succession- but easier to argue for a new PD 1 rather than more of the same if treatment not successful. 

                        However, some folks have given up Keytruda as NED but are keeping that as an option if retreatment needed at a later date….and keytruda does seem to be marginally better than nivo as a sole agent at the current state of knowledge…

                        Just wanted to let you know that treatment with a drug may have implications for what might be available later. Like you , I wanted treatment at stage 3 in the hope of heading off stage iv… .

                        Platelets can be down for all sorts of reasons- mishandled sample is only one of a number. Think you said you had changed diet and gone vegan ? Are you sure you are getting enough iron and B12 on the new diet. Daughter is a vegan and this is one of my concerns .. although B12 stores should last for ages…

                        See what they say… and keeping lymph nodes with tiny traces doesn't seem a silly choice given the lack of evidence for CLND leading to better survival outcomes.

                        Best of wishes

                        Deb

                         

                         

                         

                         

                        debwray
                        Participant

                          Yes be lucky !

                          Not saying you would deffo be barred BUT some trials demand no previous Immunotherapy or say no previous PD1 or say no previous immunotherapy in the previous 6 weeks – a washout period. It would differ by trial .. you could get a feel for it by looking at exclusion criteria .for stage iv melanoma trials on clinical trials.gov…… but this would only be needed if you progressed to stage iv . Nivo and keytruda are both PD1 drugs- but work in slightly different ways. Think it is not settled if it is worth trying them both in succession- but easier to argue for a new PD 1 rather than more of the same if treatment not successful. 

                          However, some folks have given up Keytruda as NED but are keeping that as an option if retreatment needed at a later date….and keytruda does seem to be marginally better than nivo as a sole agent at the current state of knowledge…

                          Just wanted to let you know that treatment with a drug may have implications for what might be available later. Like you , I wanted treatment at stage 3 in the hope of heading off stage iv… .

                          Platelets can be down for all sorts of reasons- mishandled sample is only one of a number. Think you said you had changed diet and gone vegan ? Are you sure you are getting enough iron and B12 on the new diet. Daughter is a vegan and this is one of my concerns .. although B12 stores should last for ages…

                          See what they say… and keeping lymph nodes with tiny traces doesn't seem a silly choice given the lack of evidence for CLND leading to better survival outcomes.

                          Best of wishes

                          Deb

                           

                           

                           

                           

                          SOLE
                          Participant

                            Thank you Deb for this.

                            As I am not at all familiar with trials, you say that if I use PD-1 now in the form of nivo, I wont be able to use Keytruda later for example?

                            We dont have Nivo in Canada but Keytruda. That's why that trial seemed good to me. And we will likely never have the combo available as regular treatment, at least in Quebec. It is simply too expensive for our public provincial health system. 

                            About being pro active, with my existing condition of low platelets (40 000 detected by the machine last week but I did 63 000 just before my surgery on sept 9th.), I am in serious trouble for future clinical trials. My oncologist said to me that I would be in trouble using immunotherapy if platelets dont rise. 

                            Also saw my new derm today and she did two punch biopsies. 30 minutes later I was bleeding through the band aids like a pig. I should have told her to use cotton ball and hypafix… Came back home with a good portion of the back of my shirt soaked in blood. Took some large gauze and fixed the two punch biopsies with hypafix.

                            I hear you about the 6 months. But do all stage 4 trials demand a clear path for PD-1? Is nivo and keytruda treated the same when it comes to PD-1?

                            Also, I'm trying my luck with this trial despite my platelet condition. I will talk to the hospital nurse tomorrow. 

                            Wish me luck!

                            SOLE
                            Participant

                              Thank you Deb for this.

                              As I am not at all familiar with trials, you say that if I use PD-1 now in the form of nivo, I wont be able to use Keytruda later for example?

                              We dont have Nivo in Canada but Keytruda. That's why that trial seemed good to me. And we will likely never have the combo available as regular treatment, at least in Quebec. It is simply too expensive for our public provincial health system. 

                              About being pro active, with my existing condition of low platelets (40 000 detected by the machine last week but I did 63 000 just before my surgery on sept 9th.), I am in serious trouble for future clinical trials. My oncologist said to me that I would be in trouble using immunotherapy if platelets dont rise. 

                              Also saw my new derm today and she did two punch biopsies. 30 minutes later I was bleeding through the band aids like a pig. I should have told her to use cotton ball and hypafix… Came back home with a good portion of the back of my shirt soaked in blood. Took some large gauze and fixed the two punch biopsies with hypafix.

                              I hear you about the 6 months. But do all stage 4 trials demand a clear path for PD-1? Is nivo and keytruda treated the same when it comes to PD-1?

                              Also, I'm trying my luck with this trial despite my platelet condition. I will talk to the hospital nurse tomorrow. 

                              Wish me luck!

                            debwray
                            Participant

                              First impression- looks like a good option.  No placebo !

                              Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

                              Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

                              Scans- best guess three monthly. Details will be in trial invitation.

                              Drugs co usually state will pay reasonable cost of travel- whatever that means.

                              probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

                              My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

                              Good luck

                              Deb

                               

                               

                              debwray
                              Participant

                                First impression- looks like a good option.  No placebo !

                                Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

                                Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

                                Scans- best guess three monthly. Details will be in trial invitation.

                                Drugs co usually state will pay reasonable cost of travel- whatever that means.

                                probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

                                My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

                                Good luck

                                Deb

                                 

                                 

                                Gene_S
                                Participant

                                  My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

                                  We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

                                  Hope this helps some with your question on what we in the US pay for.

                                  Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)

                                  Gene_S
                                  Participant

                                    My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

                                    We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

                                    Hope this helps some with your question on what we in the US pay for.

                                    Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)

                                    Gene_S
                                    Participant

                                      My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

                                      We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

                                      Hope this helps some with your question on what we in the US pay for.

                                      Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)

                                        Carole K
                                        Participant

                                          Hi Sole,

                                          I just read all of your replies.  If you decide to go with this trial contact Ronald McDonald house to see about housing.  I am not sure if they allow long term stays or not.  Pleae know I am here for you.  I am so so so happy you are pro active in your decisions.  That is so important.  You are dong your research and when you make your decision  NEVER EVER LOOK BACK..  IT MEANS you mad the decision that is right for you.  Keep putting one foot in front of the other.  Sending you big hugs and lots of love.  Hang tough. !!  You can do this !!!  NEVER NEVER NEER GIVE UP HOPE.  

                                          Love and Light

                                          Carole K 

                                          Carole K
                                          Participant

                                            Hi Sole,

                                            I just read all of your replies.  If you decide to go with this trial contact Ronald McDonald house to see about housing.  I am not sure if they allow long term stays or not.  Pleae know I am here for you.  I am so so so happy you are pro active in your decisions.  That is so important.  You are dong your research and when you make your decision  NEVER EVER LOOK BACK..  IT MEANS you mad the decision that is right for you.  Keep putting one foot in front of the other.  Sending you big hugs and lots of love.  Hang tough. !!  You can do this !!!  NEVER NEVER NEER GIVE UP HOPE.  

                                            Love and Light

                                            Carole K 

                                            Carole K
                                            Participant

                                              Hi Sole,

                                              I just read all of your replies.  If you decide to go with this trial contact Ronald McDonald house to see about housing.  I am not sure if they allow long term stays or not.  Pleae know I am here for you.  I am so so so happy you are pro active in your decisions.  That is so important.  You are dong your research and when you make your decision  NEVER EVER LOOK BACK..  IT MEANS you mad the decision that is right for you.  Keep putting one foot in front of the other.  Sending you big hugs and lots of love.  Hang tough. !!  You can do this !!!  NEVER NEVER NEER GIVE UP HOPE.  

                                              Love and Light

                                              Carole K 

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