For those of you who don't know...back in 2010 I joined 33 other ratties with resected Stage IV melanoma in a trial of nivo (with peptide vaccines that did NOT help). I had had 2 cutaneous lesions, a positive node, went on to have a resected lung met, SRS to a brain met, and surgery for a tonsilar met, but was NED at entry to my trial. There were 30 ratties in an advanced melanoma arm as well. Eventually that trial morphed into many, many different arms to include: folks with prior use of ipi, to stop requiring the vaccines and HLA positive typing, the ipi/nivo combo and all sorts of things.
However, here are the results of my NED 33: C'est moi!!! Results from the 33 ratties in my Nivolumb/Opdivo trial...published!
With my thoughts: My Nivo (Opdivo) trial - first dose - 4 years ago 12/29/2010 - thoughts...
FYI: I was treated with only 1mg/kg of nivo, every 2 weeks for 6 months, then every 3 months for 2 more years.
Now there is this:
In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients). The patients were treated for a period of up to 1 year or until disease recurrence, a report of unacceptable toxic effects, or withdrawal of consent. The primary end point was recurrence-free survival in the intention-to-treat population.
At a minimum follow-up of 18 months, the 12-month rate of recurrence-free survival was 70.5% in the nivolumab group and 60.8% in the ipilimumab group. Treatment-related grade 3 or 4 adverse events were reported in 14.4% of the patients in the nivolumab group and in 45.9% of those in the ipilimumab group; treatment was discontinued because of any adverse event in 9.7% and 42.6% of the patients, respectively. Two deaths (0.4%) related to toxic effects were reported in the ipilimumab group more than 100 days after treatment.
Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab
Here is a link to the full article: Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. Weber, et al. NEJM