Day 4 of ipi/novo – minimal side effects. Does that mean anything?

This is a little more detailed 5 year data where article goes into great detail. https://www.nejm.org/doi/full/10.1056/nejmoa1910836

My adventure with checkmate 067 starts in Jan of 2014 and ran for 5 years and 9 months until grade 3 colitis put a stop to treatments. To understand a little about the trial which was blinding for over 4 years, which meant I didn’t know what I was getting or had gotten in the way of treatment. I kind of knew that nivo was going into my arm every two weeks by how I felt afterwards, but it wasn’t until the trial was unblinded that I found out that I had been in the nivo monotherapy arm of the trial. as far as partial responder, that was based on a whole bunch of ct scans, never a PET-ct because it was not funded in the trial and I had to ask special permission to get one in Canada . My oncologist was able to get approval for a PET-ct and it showed that the tumor that kept showing up in my lung had no SUV uptake, which means the tumor was probably just scar tissue showing up. So 8 years later from finding out that I was stage 4, I and now considered NEAD (no evidence of active disease. I also had a little brain SRS treatment in Oct. of 2013 to zap 3 small little tumors in my brain which were discovered doing clinical trial protocols before starting. It was pretty sporty back in the summer of 2013!

The trial was designed that you were allowed to stay on treatment with nivo until progression or side effects IRAE’s made you stop. You have to remember this was the trial that led to the combination and nivo approvals. we didn’t know much about the drugs and we sure didn’t know what would happened if you stopped as a partial responder. It would have probably been easier to stop if they would have done PET-ct once a year, so you could know if tumors were active or just dead tissue. Clinical trials are interesting and they take lots of blood samples and do lots of scans, so you feel closely watched.