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Yervoy (Ipilimumab) vs. OPDIVO (Nivolumab) Phase III Clinical Trial

Forums General Melanoma Community Yervoy (Ipilimumab) vs. OPDIVO (Nivolumab) Phase III Clinical Trial

  • Post
    Speedster
    Participant

    Today I was patient #1 at Baylor Samons for the Yervoy (Ipilimumab) vs. OPDIVO (Nivolumab) Phase III Clinical Trial.   Designed for Stage III patients – resected tumors, NED to determine if either is effective as an adjuvant therapy.

    The trial will have 800 participants across the country.  Who else is in and what are you experiencing as you ramp up the treatment? 

    Nothing noticeable for me after the first treatment today.  

Viewing 11 reply threads
  • Replies
      Speedster
      Participant

      Here's a link to the study and it includes Stage IV resceted patients. 

      Official Title:A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

      https://clinicaltrials.gov/ct2/show/NCT02388906?term=Melanoma+adjuvant&recr=Open&rank=31

      Speedster
      Participant

      Here's a link to the study and it includes Stage IV resceted patients. 

      Official Title:A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

      https://clinicaltrials.gov/ct2/show/NCT02388906?term=Melanoma+adjuvant&recr=Open&rank=31

      Speedster
      Participant

      Here's a link to the study and it includes Stage IV resceted patients. 

      Official Title:A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

      https://clinicaltrials.gov/ct2/show/NCT02388906?term=Melanoma+adjuvant&recr=Open&rank=31

      Aundrea
      Participant

      Hey Speedster.  I told you a while back my husband is inlisted in this trial.  He goes this coming Monday to Baylor Sammons to meet with Dr. Cowey and take all the testing.  If all testing is good he will start the following week.  How long did it take you to get the infusion?  So far no side effects or any fatigue?

        Joe.Pro
        Participant

        Hi!  I am currently considering this trial or a vaccine trial.  I have surgery in 2 weeks and am Stage III.  Exciting to know we now have more options than just Interferon.

        Speedster
        Participant

        I pray your surgery goes well.  27 lymph nodes removed from my left arm pit and the sentinal node from my right back at the end of January.   It was rather extensive, yet I've recovered well.  I'm Stage IIIc, which is not too great.  What are you having done in a week?

        I completed my first treatment and am working hard to manage the side effects, which are many, yet I'm trying to consider them a blessing as they mean the drug is working.

        Plan to enter the tiral?

         

        Speedster
        Participant

        I pray your surgery goes well.  27 lymph nodes removed from my left arm pit and the sentinal node from my right back at the end of January.   It was rather extensive, yet I've recovered well.  I'm Stage IIIc, which is not too great.  What are you having done in a week?

        I completed my first treatment and am working hard to manage the side effects, which are many, yet I'm trying to consider them a blessing as they mean the drug is working.

        Plan to enter the tiral?

         

        Speedster
        Participant

        I pray your surgery goes well.  27 lymph nodes removed from my left arm pit and the sentinal node from my right back at the end of January.   It was rather extensive, yet I've recovered well.  I'm Stage IIIc, which is not too great.  What are you having done in a week?

        I completed my first treatment and am working hard to manage the side effects, which are many, yet I'm trying to consider them a blessing as they mean the drug is working.

        Plan to enter the tiral?

         

        Joe.Pro
        Participant

        Hi!  I am currently considering this trial or a vaccine trial.  I have surgery in 2 weeks and am Stage III.  Exciting to know we now have more options than just Interferon.

        Joe.Pro
        Participant

        Hi!  I am currently considering this trial or a vaccine trial.  I have surgery in 2 weeks and am Stage III.  Exciting to know we now have more options than just Interferon.

        Speedster
        Participant

        To double blind the study, you have to take both meds, when one is placebo. The Ipi bag took 90 mins and the Nivo 1 hour with 30 mins inbetween. Blood was taken before, during and after treatment. Marcella, who runs the chemo unit is a super star.   So far the Baylor oncology team is top notch. 

        Speedster
        Participant

        To double blind the study, you have to take both meds, when one is placebo. The Ipi bag took 90 mins and the Nivo 1 hour with 30 mins inbetween. Blood was taken before, during and after treatment. Marcella, who runs the chemo unit is a super star.   So far the Baylor oncology team is top notch. 

        Speedster
        Participant

        To double blind the study, you have to take both meds, when one is placebo. The Ipi bag took 90 mins and the Nivo 1 hour with 30 mins inbetween. Blood was taken before, during and after treatment. Marcella, who runs the chemo unit is a super star.   So far the Baylor oncology team is top notch. 

      Aundrea
      Participant

      Hey Speedster.  I told you a while back my husband is inlisted in this trial.  He goes this coming Monday to Baylor Sammons to meet with Dr. Cowey and take all the testing.  If all testing is good he will start the following week.  How long did it take you to get the infusion?  So far no side effects or any fatigue?

      Aundrea
      Participant

      Hey Speedster.  I told you a while back my husband is inlisted in this trial.  He goes this coming Monday to Baylor Sammons to meet with Dr. Cowey and take all the testing.  If all testing is good he will start the following week.  How long did it take you to get the infusion?  So far no side effects or any fatigue?

      Bubbles
      Participant

      Hey Speedster,

      I wish you luck in this trial.  Stage IV NED  patients are admitted as well.   I posted this on in March:  http://www.melanoma.org/find-support/patient-community/mpip-melanoma-patients-information-page/ipi-vs-nivo-trial-resected

      I started the Opdivo (nivo) arm of this trial in 2010 (along with 33 other amazing ratties!!!!!) when I was Stage IV, NED.  I remain NED.  Posted this in March as well:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/new-ipi-vs-nivo-trial-for-resected.html

      My blog tells the story of my 2 1/2 years on Nivo/Opdivo (the BMS anti-PD1 product).  This is an update on my fellow ratties from March:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

      Here is a post when my trial results were published:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

      My thoughts on same, 4 years after the start:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/my-nivo-opdivo-trial-first-dose-4-years.html

      So…for all the ratties who went there first….Great thanks.  Celeste

        Joe.Pro
        Participant

        Thank you Celeste for paving the way – without you and so many others like you who were brave enough to do anything it took to fight this awful disease, people like I and many others would be in the dark!  May God bless you for your sacrifices.

        Bubbles
        Participant

        You are very sweet to say that, but the truth is MANY, MANY others paved the way for me as well…in everything from general comprehension of cancer, to treatments, to immunotherapy, to anti-PD1.  Here is a post I wrote in 2013 that tells the story of the BMS anti-PD1 product (Opdivo/Nivo) and how we melanoma patients ever got to take it in the first place!

        http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/06/love-potionor-patient9.html

        WIshing all of you my best!!!  C

        Bubbles
        Participant

        You are very sweet to say that, but the truth is MANY, MANY others paved the way for me as well…in everything from general comprehension of cancer, to treatments, to immunotherapy, to anti-PD1.  Here is a post I wrote in 2013 that tells the story of the BMS anti-PD1 product (Opdivo/Nivo) and how we melanoma patients ever got to take it in the first place!

        http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/06/love-potionor-patient9.html

        WIshing all of you my best!!!  C

        Bubbles
        Participant

        You are very sweet to say that, but the truth is MANY, MANY others paved the way for me as well…in everything from general comprehension of cancer, to treatments, to immunotherapy, to anti-PD1.  Here is a post I wrote in 2013 that tells the story of the BMS anti-PD1 product (Opdivo/Nivo) and how we melanoma patients ever got to take it in the first place!

        http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/06/love-potionor-patient9.html

        WIshing all of you my best!!!  C

        Joe.Pro
        Participant

        Thank you Celeste for paving the way – without you and so many others like you who were brave enough to do anything it took to fight this awful disease, people like I and many others would be in the dark!  May God bless you for your sacrifices.

        Joe.Pro
        Participant

        Thank you Celeste for paving the way – without you and so many others like you who were brave enough to do anything it took to fight this awful disease, people like I and many others would be in the dark!  May God bless you for your sacrifices.

        Speedster
        Participant

        Oh my… The Brave 33 with one who goes by "Bubbles"!! 

        Thanks for the encouragement that you are as after treatment #1, I'm pretty hammered by the side effects.  And the side effects mean the drug is working, so I've working hard to be thankful for them.  A big shift. 

        I hope I'm on the Optdivo (Nivo) leg of the trial as the trail of Keytruda (Pembro) vs. Yervoy (Ipi) just published showed so clearly that Keytruda a PD-1 inhibitor like Optdivo was so much more effective, that they stopped the trial so those on Yervoy could shift to it.  Not that Yervoy is not effective, yet it's less effective and more toxic. 

        Progress build on your courage and victory. 

         

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Debbieamccoy
        Participant

        I was all set to start this trial yesterday  until the center that did my surgergy took their time submitting my tissue sample and I missed the cutoff . I'm now starting Ipi. 

        Speedster
        Participant

        Oh my… The Brave 33 with one who goes by "Bubbles"!! 

        Thanks for the encouragement that you are as after treatment #1, I'm pretty hammered by the side effects.  And the side effects mean the drug is working, so I've working hard to be thankful for them.  A big shift. 

        I hope I'm on the Optdivo (Nivo) leg of the trial as the trail of Keytruda (Pembro) vs. Yervoy (Ipi) just published showed so clearly that Keytruda a PD-1 inhibitor like Optdivo was so much more effective, that they stopped the trial so those on Yervoy could shift to it.  Not that Yervoy is not effective, yet it's less effective and more toxic. 

        Progress build on your courage and victory. 

         

        Speedster
        Participant

        Oh my… The Brave 33 with one who goes by "Bubbles"!! 

        Thanks for the encouragement that you are as after treatment #1, I'm pretty hammered by the side effects.  And the side effects mean the drug is working, so I've working hard to be thankful for them.  A big shift. 

        I hope I'm on the Optdivo (Nivo) leg of the trial as the trail of Keytruda (Pembro) vs. Yervoy (Ipi) just published showed so clearly that Keytruda a PD-1 inhibitor like Optdivo was so much more effective, that they stopped the trial so those on Yervoy could shift to it.  Not that Yervoy is not effective, yet it's less effective and more toxic. 

        Progress build on your courage and victory. 

         

      Bubbles
      Participant

      Hey Speedster,

      I wish you luck in this trial.  Stage IV NED  patients are admitted as well.   I posted this on in March:  http://www.melanoma.org/find-support/patient-community/mpip-melanoma-patients-information-page/ipi-vs-nivo-trial-resected

      I started the Opdivo (nivo) arm of this trial in 2010 (along with 33 other amazing ratties!!!!!) when I was Stage IV, NED.  I remain NED.  Posted this in March as well:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/new-ipi-vs-nivo-trial-for-resected.html

      My blog tells the story of my 2 1/2 years on Nivo/Opdivo (the BMS anti-PD1 product).  This is an update on my fellow ratties from March:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

      Here is a post when my trial results were published:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

      My thoughts on same, 4 years after the start:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/my-nivo-opdivo-trial-first-dose-4-years.html

      So…for all the ratties who went there first….Great thanks.  Celeste

      Bubbles
      Participant

      Hey Speedster,

      I wish you luck in this trial.  Stage IV NED  patients are admitted as well.   I posted this on in March:  http://www.melanoma.org/find-support/patient-community/mpip-melanoma-patients-information-page/ipi-vs-nivo-trial-resected

      I started the Opdivo (nivo) arm of this trial in 2010 (along with 33 other amazing ratties!!!!!) when I was Stage IV, NED.  I remain NED.  Posted this in March as well:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/new-ipi-vs-nivo-trial-for-resected.html

      My blog tells the story of my 2 1/2 years on Nivo/Opdivo (the BMS anti-PD1 product).  This is an update on my fellow ratties from March:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/03/one-more-tampa-trip-update-on-33.html

      Here is a post when my trial results were published:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html

      My thoughts on same, 4 years after the start:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/my-nivo-opdivo-trial-first-dose-4-years.html

      So…for all the ratties who went there first….Great thanks.  Celeste

      Nmgn8019
      Participant
      Hey Speedster and others.

      I am enlisted in this trial (started beginning of July 2015) as well.

      In contrary to a quote that there are approx. 800 participants across the country, that must be a misunderstanding since I live in The Netherlands (Europe). Today my oncologist told that the recruitment phase has ended by yesterday.

      Until now the trial is going well for me. One incident until now…..I have visited the emergency department only once (a month ago) due to excessive diarrhea. The diarrhea continues unfortunately but at clearly less intensity.

      Nice to meet others in the world dealing with the same clinical trial!

        Speedster
        Participant

        Hey, I've been away for a long time since I failed this trail having advanced to Stage IV.  I was on the Ipi leg and once I advanced to Stage IV, I went on Nivo and it about did me in.  Thankfully, MD Anderson patched me back together and in short order, Pembro took out the turmors that had spread all through my cheast and lungs, neck and into my liver.  I just passed my one year NED anniversary.   How did all of you do?  I pray 100% well as I didn't, yet boy God's grace in the end, a diving catched with Pembro saved me.  

      Nmgn8019
      Participant
      Hey Speedster and others.

      I am enlisted in this trial (started beginning of July 2015) as well.

      In contrary to a quote that there are approx. 800 participants across the country, that must be a misunderstanding since I live in The Netherlands (Europe). Today my oncologist told that the recruitment phase has ended by yesterday.

      Until now the trial is going well for me. One incident until now…..I have visited the emergency department only once (a month ago) due to excessive diarrhea. The diarrhea continues unfortunately but at clearly less intensity.

      Nice to meet others in the world dealing with the same clinical trial!

      Nmgn8019
      Participant
      Hey Speedster and others.

      I am enlisted in this trial (started beginning of July 2015) as well.

      In contrary to a quote that there are approx. 800 participants across the country, that must be a misunderstanding since I live in The Netherlands (Europe). Today my oncologist told that the recruitment phase has ended by yesterday.

      Until now the trial is going well for me. One incident until now…..I have visited the emergency department only once (a month ago) due to excessive diarrhea. The diarrhea continues unfortunately but at clearly less intensity.

      Nice to meet others in the world dealing with the same clinical trial!

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