Monday, September 16, 2013

Nivolumab (anti-PD1) trial....33 months later!

Latest stats:

121 months - since diagnosed with melanoma (That's over TEN years, folks!)
41 months - since being Stage IV
35 months - NED
33months - since the start of my BMS anti-PD1 (Nivolumab and peptide vaccine trial) at Moffitt, in Tampa, Florida

Had scans of neck, chest and pelvis as well as an MRI of my brain on the sixth.  All were pronounced free and clear by Bentie and the radiologists. It was the usual fun and games plus an emergency change of location when the scanner broke down at the site of our planned appointment. But, B prevailed and "made it work"! And as a reward, I got to have dinner with sweet friends.

The following week, it was off to Tampa once again, on Friday the 13th!!!, for my 3 month POST trial follow-up!

Here's the lowdown...

I am fine. Have had horrible mouth ulcers since before May 20th...which Dr. Weber noted and was impressed by on my June visit. They are resolving now thanks to the help of my dentist who treated me with Peridex, an antibacterial mouth wash as well as 24 hours worth of Valcyclovir (an anti-viral) on the chance that my lesions had developed a super infection with one or the other. We had contacted Weber as well and he suggested magic mouthwash again....but that just wasn't getting it! Within 48 hours I was MUCH better! We reported all this to Weber who was still impressed with the two residual ulcers under my tongue (as was my dentist when he saw me a week ago and told me, "Darlin! That hurts me just to look at it!" I told him it was that point....and was looking FABULOUS!!) All this discussion led to the revelation that I was the only patient out of 120 who had actually developed ulcers. Others had developed what he termed as mucositis with a sore, irritated mouth....but no ulcers. Then he started pondering which had helped....the antibacterial wash or the antiviral....clearly wishing we had done a culture and Tzanck stain before the meds....and Brent and I had thought of that...but I just wanted some relief....which Weber was fine with....but the dude is a researcher! That led him to start thinking about the five patients (of 120) who have developed shingles and whether my ulcers may be related to that...  In the end, I said if it was still ongoing in two weeks, I would have both tests done and we would go from there.

Other data:  No additional patients in my NED cohort have relapsed in the past 9 months!! And obviously, but can't say it enough...though with fingers crossed....that means that NONE of the 6 of us who had prior brain mets have relapsed at all!!!  Go little ratties! Go!

Final news:  So while the 83% response rate in my NED group is holding, and is obviously fabulous, I asked him: "When will the data from this cohort really be significant? Since we were NED it is hard to say when we would really have relapsed....though obviously the usual number for Stage IV folks to do that is in about 4-6 months...but still, accounting for individual differences....when do you think we have really proven something?"
His answer:  "When the median of the group reaches 48 months. The median is at about 22 months right now, though certainly we have you at 33 months and a few others that far along. We will be presenting the 24 month data. But the real break point will be when the median is 48 months after the start of the trial."  He went on to point out that he had never seen anyone relapse after making it 48 months, and thinks the 24 month data will have significance as well. Furthermore, he said that the data he already has, has convinced BMS to do a Phase III adjuvant trial and that the company is currently deciding what to use as the control....ipi, interferon, or something else.  Additionally, he is adding yet another arm to MY trial that will use ipi and Nivolumab concomitantly (NOT    sequentially) in NED patients. He is worried about significant side effects when giving these drugs together and I am not sure when slots will be open though it seemed to be in the next couple of months.

Guess that's about all we learned this go round. No scans for me for 6 months! Can hardly imagine!!

Hang in there, ratties! Love - c


  1. Some really positive news! You and your co-hort buds all doing great! The mouth sores FINALLY starting to get better! And now you don't go back for six months! :)

  2. Hi, If it is ok with you can you e-mail me regarding a recent stage 3c diagnosis? Thank you. Lucy

  3. Hey Lucy,
    Your email isn't listed in your profile. If you will place it in a message here, I will be happy to do so.