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Tuesday, February 05, 2019 6:03:01 PM
So this trial is measuring Nivo + Bev (Avastin) and Nivo + low dose Bev in Recurrent GBM.
https://clinicaltrials.gov/ct2/show/study/NCT03452579#contacts
And this trial (also a P2) is measuring Nivo + Bev vs. Nivo + low dose Bev in Newly Diagnosed GBM.
https://clinicaltrials.gov/ct2/show/study/NCT03452579#contacts
The primary endpoint for the newly diagnosed GBM trial is OS at 12 months.
Secondary is OS at 3 years, + ORR + DOR + PFS - all at 3 years + PFS at 6 months
They are doing another P2 trial in unmethylated newly diagnosed GBM using Nivo, Ipi, short-course radiation - so no TMZ with a primary endpoint for OS at one year, secondary endpoint is 2 years.
https://clinicaltrials.gov/ct2/show/NCT03367715
And also in newly diagnosed GBM, BMY is comparing SOC w/Nivo against placebo - in MGMT methylated
It's a P3 trial, with co-primary endpoints of PFS at 35 months and OS at 69 months
https://clinicaltrials.gov/ct2/show/NCT02667587?term=CheckMate+548&rank=1
First off, I find it interesting that they are measuring the primary for some of these trials, including two of them at 12 months for newly diagnosed GBM. I can understand using that time frame in recurrent GBM. The primary in the DCVax-L and Nivo trial measures OS at 12 months too.
I hope they don't plan to pull an Optune on us. At least the P3 in newly diagnosed is going out to 35 months.
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