Friday, September 11, 2015

Latest update on my Nivo/Opdivo study peeps and me...

I noted this 1 year ago:   "33 patients were enrolled.  10/33 patients relapsed. Of the 10 relapsed patients, five died due to metastatic melanoma; three were rendered free of disease surgically and remain disease-free at 2, 27 and 54 weeks after relapse.  One patient had spontaneous regression... and has been free of disease for over 3 years.  One additional relapsed patient is alive and on active therapy with dabrafenib plus trametinib." 

We have learned from Dr. Weber this week that "now there are 6 deaths, but no additional relapses".  To those of you who lost your loved ones, I am so sorry and hope that smiles from sweet memories have replaced at least a little of your pain.

This fact, from 6 months ago, remains true:  "It remains important to remember that only 2 of the 10 of us with prior brain mets early on with undetected disease at admission to the study that was quite progressed and another not that long ago with a lung met that was resected, rendering them NED."

While not good enough, these are pretty good results for Stage IV peeps like me.  As a reminder, I (along with 9 others) was given 1mg/kg Nivo every 2 weeks for 6 months (along with 6 IM peptide injections), followed by Nivo alone every 3 months for 2 additional years.  The next 10 peeps did 3mg/kg Nivo...with same vaccines and schedule.  The next 10 did 10mg/kg Nivo...same tadah.  There are 3 additional ratties whose category I am not sure about.

We also have confirmation that Dr. Weber is moving to NYU.  He will be following me there in the future.

So, enjoy: New York, New York...Alicia Keys and Jay Z

Thanks, Stevie.  Much love to you all...especially the ratties! - c   


  1. Six is still too many... Here is a question though -- Do we know which group they were in? I mean, the 1 mg, 3 mg, or 10 mg?

  2. I agree. I'm sure Weber and the trial coordinator do....but I do not know the dosage level of every relapsed patient. From the Dec 2014 published report of the study...we know that the two patients with prior brain mets who relapsed were in cohort 1 (the 1mg/kg group). While one of those passed early on, the other developed a lung met, which was resected leaving them NED. The guy with the spontaneous remission was also in corhort 1. Beyond that, I don't the details of dosage level and patient relapse or death. Once Weber intimated that the dosage level did not appear to be significant, but that was some time ago.

  3. 70% relapse free rate is excellent. Makes you wonder if the peptide had some effect even though testing may have indicated not. Although all of the 33 patients were considered ned at start correct? Any way you look at your trial though they are very good numbers when compared to responce rates of nivo or keytruda alone.

    1. Also makes me think about disease burden and if nivo and keytruda response rates could be much higher in stage 3 and m1a.

  4. It is very clear that the peptide vaccines used in my trial had no positive effects on outcome...there are several posts here addressing those results and why. It is even possible that they could have been deleterious by sequestering important T cells. My arm consisted of Stage IV patients rendered NED via surgery, srs or both. There was a Stage IV, non-resectable sister arm, given the same meds and dosage protocol. They had the usual 35-40% response rate usually attained with anti-PD1. Research has long been telling us that immunotherapy works best in patients with the lowest tumor burden. I think we are proof. It is just like treating patients with a bad infection that IS killed by a particular antibiotic. If the antibiotic is administered before the infection is overwhelming, it will work. If the infection gets the upper hand...all the antibiotics in the world will not reign it in and sepsis will set in. The only other tid bits gleaned from my trial overall is that patients with the lowest levels of myeloid derived supressor cells, with itching and vitiligo did best. All of this is not to say that a viable vaccine for melanoma is not possible. Hopefully, that day will come. Additionally, insurance companies and the FDA need to pay attenton to these results and provide drugs like anti-PD1 to patients EARLY rather than late. The companies would save money and more patients would survive with fewer miserable treatments!