RE:Dr. Chamie Interview - Quilt 3.032 study (N-803 + BCG)
Interesting find!
I'm confused about the protocol.
"BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36."
So they complete treatment after induction of 6 weeks but sometimes need another 6 weeks of treatment? And then they keep getting study drugs at months 6,9,12,18. If there is residual disease but at a level that is very small, the repeated treatments for the second round of 6 weeks and then the month 6,9, 12,18 seem to me to be them just constantly chasing down the disease before it reaches a large enough size to be detectable. They call it maintenance but I feel that constantly giving the drug is a treatment type intervention which make is hard to say that the CR is durable....if you are still getting treated.
Does that make sense?
With Ruvidar the same thing could be said of the 180 day treatment but the patients who have no disease at 270,360, 450 and beyond are truly showing no return of disease. The original 1b patients are the best examples as they are years out now.