Nivo/Ipi Combo Side Effects

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

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

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

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

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

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

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

Thanks in advance,
kali

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

Thanks in advance,
kali

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

Thanks in advance,
kali

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.

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.

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.