9 months after Nivolumab trial...stats, f/u, what we learned....

Latest stats:
127 months - since melanoma diagnosis (over 10 1/2 years!!!)
47 months - Stage IV (almost 4 years)
41 months - NED
39 months - since start of Nivolumab (anti-PD1 trial)

Scans (the usual CT of neck, chest, and abdomen with an MRI of the brain) on 2/28 were all negative for melanoma lesions.  Bent shipped the reports and CD's off to Tampa as usual and we were on our way for a 6 month recheck, after a 3 month follow-up done in September, with my last infusion of bug juice in June 2013.  We drove to Atlanta with no real excitement on the 6th, for a pretty easy flight down to Tampa...despite their sightings of water spouts!!!....that afternoon.  Here's the story...

Our flight was a bit later than our usual, but that worked out for the best, as Tampa weather had cleared by the time we landed.  B had known the weather probably wouldn't be that great, so rather than any grand adventure, we had decided to pick up supper at  the Pho Quyen location nearest our La Quinta.  Is Tampa a Scrabble lover's town or what??? (You know the one, Ruthie.  In the corner of the shopping area with the grocery store where the lady liked your nail polish and the horrible Jason's Deli??!!)  BUT!  The night before we were to leave, B gets an email from a wine club we joined when we were in Sonoma.  Peter Spann, of Spann wines, was to be doing a tasting...in Tampa....Thursday evening!!!  He's a vintner (And I mean a hands on one!!!....his hands were stained purple when we met him!) Brent and I met at Bungalow 313 in Sonoma in October of 2011.  We joined his wine club back then.  (I'm telling you, the wines he and his wife makes are amazing.  You should definitely check them out!!)  Brent was so excited.  He and Peter have chatted on the phone over the years, with their last conversation just a couple of weeks ago! We landed at 6:30.  The tasting was to be over at 7.  I didn't care.  This was going to happen!!! We dashed to the rental car place.  No cars in the compact line.  No cars in the economy line.  I'm checking out a Kia, Sol..located in the "standard" line-up.  As ever in Alamo's fluid roster, it HAS been designated in both categories before!  I find it acceptable as B rushes to the kiosk.  With a wave, the attendant says it's ours since there ARE no others.  We're off!!!  The GPS can't manage to get over its attachment to other cities and goes a bit wonky for a while.  B calls the location of the tasting...yes, Peter Spann is there...yes, he'll be there for a while longer.  We get headed in the right direction.  Gotta say, that Sol's got pretty good pick-up.  I fear Peter will tag B as a stalker.  We pull in.  Fair size gathering in a little wine shop.  We are greeted by the owners of the shop and enjoy a sip.  Peter is chatting with another gentleman.  Turns out we had a great time with Peter and a school chum of his who happens to live in the Tampa area.  They were meeting up for the first time in 40 years!!!  In fact, we ended up going to dinner with them at Pho Quyen!!  It was a pleasure to listen to the stories of strangers, who now aren't quite!!!

Our visit to Moffitt began at the butt crack of Tampa dawn...0700!!!  That's how we roll in Tampa town!  For the first time in over three years, our visit started on the first floor in a little lab rather than in the CRU (Clinical Research Unit) and I did not have an IV started or 15 tubes of research labs drawn!!!!  You'd think that would be easy right?  Well, cute little girl had a panic attack about my new insurance, that Brent had already checked with Moffitt about, but was finally cleared to her satisfaction after she called more important billing people.  The next cute little girl managed to blow my vein after digging around in it for a bit, while asking...."Does that feel normal?"  "Why, yes.  Of course it does.  You just poked me with a sharp object, squitched it around for a while, and made a big bruise.  Normal as can be!!!"  Oh, dear...there are worse things....

Off to the "Cutaneous Clinic" i.e. Dr. Weber's office.  He noted that my vitiligo seemed a bit increased, and reported that areas of vitiligo were often preceded by significant itching due to the inflammatory reaction.  (Hmmm...wonder where he first heard that????)  He found the report of my Jan/Feb arthralgias and mouth ulcers interesting and felt they were most certainly immunologic effects, something he reported seeing persist intermittently in some of his younger patients. That was about it for me, but this is what we learned...

In my Stage IV/III melanoma, NED arm of the study:

• 33 patients have been treated
• 9 relapsed
• 4 are deceased
• 3 are back in remission (I don't know what treatment they were given.)
• 2 are in treatment currently

Per our discussion, Dr. Weber is feeling very positive about the value of treating folks who are NED with Nivo.  He noted that based on historic data - at this point in our trajectory (about 2 years give or take) he would expect 16 deaths, rather than the 4 that have occurred.  

That is an 87% overall survival rate at 2 years.  The data from this portion of the trial are to be published soon.  Despite continuing to petition BMS for expanded trials utilizing Nivo as an adjunctive and seeking approval for its use in that manner, he has not succeeded thus far.

In the Stage IV metastatic melanoma, NON-resected arm:

• In a previous study with Nivo, 107 patients were treated every 2 weeks for 2 years with a median survival of 16.8 months.
• In THIS arm of the Moffitt study, 105 patients have been treated in the manner I was, getting Nivo every 2 weeks for 6 months, then every 3 months for 2 additional years.  The median survival has been 16.7 months.  
• So...survival was equivalent with less med, fewer trips to the doc, and with sicker patients (ocular mel and a few others were allowed that were not in the first study) in the Moffitt trial.
• Thus far, the Kaplan-Meier curve at 2 years is hanging at about 20%, but folks at Moffitt feel it will settle out around 25%.

Additional Cohort 6 added:

• How this cohort is defined specifically, how many have been enrolled in total, how many may still be enrolled, I do not know, however:
• 5 patients in this cohort were admitted with brain mets.
• 4 were treated (I presume by radiation...though not certain)
• BUT...1 experienced a COMPLETE RESPONSE with just Nivo!!!!!  (Awesome, right???!!)
• There may continue to be open slots here...but I am not at all sure about that.

Additional Arm added:  

• Due to the needs of, and in cooperation with, a German company...the connection and reasons remained unclear to me....the NED arm, examining the response to Nivo AND ipi, that I noted in my prior post has been added as well.
• We were told that the news was already out about it before its start, so it has filled very quickly.  However, as of this past Friday...9 slots did remain.

Final thoughts:

• Dr. Weber feels that his work shows that Nivo is probably NOT needed at a dosing rate of every 2 weeks for 2 years, since he attained the same results as the prior study with fewer doses and sicker patients.
• While it remains unproven as yet, he also mentioned that "patients who responded, probably had all their melanoma cells eradicated" and "were basically CURED with no need for further treatment after the first course."
• Yes....he used the "C" word....and I don't mean cancer! 

 It is odd, and somewhat appalling, how very iron clad, yet extraordinarily flexible trial protocols can be. Yes, on this visit, I signed yet another 23 page consent form...noted to be "Version 13" for the same trial I have been in for over 3 years.  No matter how many times you search ClinicalTrials.gov or utilize any of the search engines I reported on earlier this month....you will NOT get the complete picture of what the trial is offering, its inclusions, nor exclusions.  They change a great deal over time.  If you are interested in ANY trial....or in ANY trial location/facility...CALL the clinical trial coordinator!  The worst you will get is...no.  But, you might get a slot in a trial you knew about, or find out about a whole new option that might prove to be the thing you or your loved one really needs!  CALL!
Wishing my very best to you all...especially my rattie peeps! - c