My Trial which has 3 arms was Unblinded after 3 years 10 months

Posted By
ed williams
11/14/2017 5:17pm
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Replies: 13

My Oncologist had a surpise for me today, after being part of Bristol Myer Squibb checkmate 067 trial of Ipi and Nivo or the Combination of both drugs for the last 3 years and 10 months, the company decided to let the remaining patients that where blinded know what they have been getting!!!! I have been a member of the forum for the last 3 years and 9 months, so many times I have been frustrated by people asking about what kind of side effects they should expect on Ipi/Nivo or either of the two Pd-1 drug and I couldn't respond from a personal point of view due to the fact that I didn't know for sure what I have been getting. I am happy to report that after 97 treatments I can finally say with 100% confidence that I am getting "Nivolumab" not placebo every two weeks. I feel like a huge weight came off my shoulder today!!! So many forum members have talked about having a plan if things stop working, well I can now put one in place with confidence!!! This is also my first offical post ever on the forum and it feels pretty good. Love you all, even the Anon's!!! Ed

Thank's for sharing Ed! Congrats

Paul

Man!  Almost 4 years of nivo!!!  You.  ARE. AWESOME!!!!  Glad you finally got to know what's what.  Ratties are great, but mousies ROCK!!!  Congrats.  love, c

I'm very happy for you Ed!! Definitive answers are so important! Please do share any future plans if/when you can. Wishing you the best always!!

Barb

Glad you finally know Ed, and thanks for all the helpful information you share and the support you provide to those on this forum. 

 

Can I ask side effects? My husband will be starting just Nivo soon.

Congrats to doing so well!
Donna

Hi Donna, I have been very lucky in the side effect department!!! Fatigue has been my constant friends during the treatments, some itching with small rash on chest area from time to time. I also develop Vitiligo on arms and legs, but when it comes to side effects it is a positive one to get, associated with positive responds. The fatigue side effect should be improved if Bristol Myer Squibb gets FDA approval for change from treatments every two weeks to every 4 weeks, FDA is going to rule early next year!!! I usually start having more energy the second week after treatment, so if they go to a 4 week schedule it would make sense that patients would feel kind of crappy 1 week out of 4 instead of 1 out of 2, plus less time spent at hospital and less needles and blood work draws would be a big plus. I hope things go great for your husband!!!Ed 

I could barely tolerate 9 months of pregnancy without knowing what the baby was going to be! Almost 4 years of not knowing..... ARGH! I might have had to pay off an infusion nurse or lab tech. LOL! Happy for you they finally spilled the beans!

The team at the Ottawa general couldn't wait to tell me, it started with my nurse asking " so have you heard the news yet?" followed up by the clinical trial ladies asking me "what do you think you have been getting?" They had some fun making me wait for the Oncologist to give me the information. Dr. Song informed me that she recieved an email last week from BMS saying that they were unmasking the last few patients on Checkmate 067. It started to make sense to me later in the day when I started thnking about the math. Ipi arm of the trial around 320 patients would have had 80% of patients progress so they would have been unmasked in the first year or so. The combination part would have had around 50% of the patients have grade 3 or 4 IRAE's so they would have been unmasked in the first year and then those that progressed would have been unmasked. Finally my arm of the trial where 40% of the patients had objective responses, so the other 60% would have over time been unmasked. The thought of working on the lab tech side of things had crossed my mind a few times. Fun thing is I have felt strongly that I have been getting Nivo, based on side effect profile and how quick my scans showed improvement at first scans at 12 weeks. My wife reminds me on a regular basis that I got it wrong (ultra sound) , we didn't want to know the sex of our child but I could have sworn that I saw a penis on the screen. To my suprise a few months later my daughter Kora-Lee was born. The first words that Kora-Lee would have heard in this world was "No way, I was sure it was a boy" LOL

LOL! You sound like my engineer husband, working it out by doing the math!   And hey... we wives will take any and every opportunity to remind you fellas "you were wrong"! ha ha ha!

Wow, Ed, that is a long time to be in the dark, I am sure you are happy to now know what you've been getting all this time. Thanks for posting :)

Jenn - stage IV NED - Completed Ipi/Nivo (Yervoy/Opdivo) + surgery

Hi Jenn, feeling like I was in the dark is a good way to describe it!!! I have been telling any one willing to listen at the hospital, that I know for sure that I had been getting Nivo based on how I felt and how well I had been doing on scans. The question that I had was "did I get Ipi?' You know that feeling of, "Ok, what will I be able to move on to next if this stops working". At least now I can think about putting together some kind of secondary(back up) plan, but hoping that it won't be necessary. I read your post earlier and I have my fingers crossed for you that the nodes will just be filled will T-cells and other immune cell and you will get great news of being "NED" . Take care!!!Ed

Thank so much Ed!

Jenn - stage IV NED - Completed Ipi/Nivo (Yervoy/Opdivo) + surgery