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Re: Titan V post# 37466

Friday, 11/18/2016 10:01:42 PM

Friday, November 18, 2016 10:01:42 PM

Post# of 48316
Continuing with the same train of thought, what is the scope of a clinical trial protocol modification? Does the current combo trial protocol not allow patients refractory to keytruda to be enrolled? What needs to be modified to the below? Aren't there a few refractory patients already in the combo trial? Is their intent to just increase the number of patients from 41 via this protocol modification?
https://clinicaltrials.gov/ct2/show/NCT02493361?term=algazi+%2B+keytruda&rank=1

Lastly, and this is where I'm going with this...is it heard of, or even possible, for an IST to be modified or merged into an industry-sponsored trial? I couldn't find any instances of this but would be interested in hearing from others.

Starting the registration trial early when the IST is just midway has me wondering why.