(Total Views: 519)
Posted On: 08/19/2025 3:13:33 PM
Post# of 156151
Re: HouseofCards #156018
If dose will be change to 700 mg , all then will count as 700 mg , and at the end after one year results should not be " tainted"..imo.
Patients will be for a long time on 700 mg.
But results will not be as good as they should , because for entire year patients developing high PD-L1 will not be given check point inhibitors..
If dose will not be change and some will be on 350 mg , they can "taint" our results of course , but statistics will show % of results in each dose.
I am only worry if they will switch all to 700 mg.
They will have a second DSMB when 20 patients will be for at least 21days on LL.
If enrollment very fast , most will be about 3 weeks on treatment and it may not be enough to see the difference between the doses , as we know for PD-L1 to become elevated it takes 30-90 days on LL.
The only thing is , most probably enrollment will not be that fast , and the 700 mg patients will start to show some improvements with cancer , and elevation of PD-L1 by the time of second DSMB evaluation..
I just still don't know how they will evaluate cancer progression as there is nothing about doing MRI time to time in the protocol..
If anyone is willing , this is a good Q to our company/Dr Jay. How you will evaluate progress with cancer for this year.
Will MRI be done ??.
Normally those things are written in the protocol.
All IMO.
Patients will be for a long time on 700 mg.
But results will not be as good as they should , because for entire year patients developing high PD-L1 will not be given check point inhibitors..
If dose will not be change and some will be on 350 mg , they can "taint" our results of course , but statistics will show % of results in each dose.
I am only worry if they will switch all to 700 mg.
They will have a second DSMB when 20 patients will be for at least 21days on LL.
If enrollment very fast , most will be about 3 weeks on treatment and it may not be enough to see the difference between the doses , as we know for PD-L1 to become elevated it takes 30-90 days on LL.
The only thing is , most probably enrollment will not be that fast , and the 700 mg patients will start to show some improvements with cancer , and elevation of PD-L1 by the time of second DSMB evaluation..
I just still don't know how they will evaluate cancer progression as there is nothing about doing MRI time to time in the protocol..
If anyone is willing , this is a good Q to our company/Dr Jay. How you will evaluate progress with cancer for this year.
Will MRI be done ??.
Normally those things are written in the protocol.
All IMO.
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