Saturday, March 8, 2014

Openings for Nivolumab Trial in Tampa!!!!

Yes, Virginia...despite the nay-sayers....there really ARE STILL some openings for a Nivolumab trial in Tampa.  Was there Friday and heard it from the horse's mouth and had to sign the amended protocol myself!!!!

Here's the deal:  An additional arm has been added to my clinical trial...technically named:  A phase 1 trial of a vaccine combining multiple class 1 peptides and montanide ISA 51 VG with escalating doses of anti-PD1 antibody BMS-936558 (now known as Nivolumab) for patients with resected stages IIIC/IV melanoma, NCI protocol P-8316.

The new arm = Nivolumab and Ipilimumab Administration
"You will receive your first dose of nivolumab with ipi within 28 days after your screening blood draws.  The dosage of nivo will be 1mg/kg with ipi at 3mg/kg for all patients in this group. Both drugs will be given.  Nivo with ipi will be given as an IV infusion as an outpatient... The next doses of nivo with ipi will be given 3, 6, and 9 weeks after the first. If at week 12 you have not had a return of your tumor, you may also receive additional doses of nivo, this time at 3mg/kg every 2 weeks for up to 2 years....."

For this study you must be NED.  You may have treated brain mets as long as they have been stable for a prescribed length of time.  I am not sure whether any specific HLA typing is required as the patients will NOT be getting the peptide vaccines.  Of course all the details of exclusions, etc. will have to be discussed with Dr. Weber and the trial coordinator. of Friday AM...NINE SLOTS REMAINED AVAILABLE!!!!!!

This trial arm differs from mine in that:
  • I got only nivo at 1mg/kg [another group got 3mg/kg, and another was given 10mg/kg] every 2 weeks for 6 months, then every 3 months for 2 additional years.
  • I got peptide vaccines with the nivo every 2 weeks for 6 months.
Additional Points:
  • FYI - you needn't feel bad about NOT getting the vaccines...the data has already been examined from my peeps and the vaccines did no good.
  • CT scans of neck, chest and abdomen with an MRI of the head were required every three months in my group...and I suspect it will be the same in this one.
  • Dr. Weber had high praise for how well the resected patients in this trial are doing. 
  • He and others are becoming more and more convinced that the lower the disease burden the greater effect immunologic treatments can attain.
It also seemed as though there remain openings in the NON-RESECTED ARM for Nivo as well (though I am not certain)!!!!

But....don't take my word for it.  CALL!!!  The folks running this trial are very accessible. Wishing you all my best.  More on the particulars of my visit coming!!! - c

H. Lee Moffitt Cancer Center & Research Institute
12902 Magnolia Drive
Tampa, FL 33612

Phone: 1-888-MOFFITT (1-888-663-3488)
Moffitt Cancer Center Switchboard:
813-745-4673 or 800-456-3434
Moffitt Cancer Center at International Plaza:

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