Phase 1 trial thing might want to know

Thanks Artie.  I was not aware of the Phase I process, so thanks for the info.  A related point that I read on a patient blog recently–you must be a patient of an institution in order to be considered for a trial at that institution.  (In order to be a patient, you need only have had one appt.)  Good luck with the NIH.

Thanks Artie.  I was not aware of the Phase I process, so thanks for the info.  A related point that I read on a patient blog recently–you must be a patient of an institution in order to be considered for a trial at that institution.  (In order to be a patient, you need only have had one appt.)  Good luck with the NIH.

Thanks Artie.  I was not aware of the Phase I process, so thanks for the info.  A related point that I read on a patient blog recently–you must be a patient of an institution in order to be considered for a trial at that institution.  (In order to be a patient, you need only have had one appt.)  Good luck with the NIH.

Hi Artie,

I'm in one of the Bristol Myers Squibb phase I trials, Nivolumab + Lirilumab. I should get my 32nd biweekly dose next week. I know UChicago, where you went up to, is one of BMS's 5 special phase I trial sites. 

To add to your experiences, I was able to get into my phase I trial during the second "dose expansion" cohort that had 16 slots for melanoma (and additional 16 slots per 5 additional cancer types). All 96 of those slots opened at the same time. Whereas the prior, first "dose escalation" cohort was much smaller and I believe followed the same slow narrow on-boarding schedule you describe.

The bigger dose expansion cohorts didn't open up until the "maximum tolerable dose" / MTD was determined by earlier dose escalation cohorts. For a different phase I trial that I didn't get into, I spent a month waiting for it to get through the dose escalation phase. But that kept getting delayed each time someone had an adverse effect that needed to be examined. So I finally jumped at the first PD-1 trial that had an opening for me, which was this one in when I hit the "dose expansion" cohort timing just right.

Wishing you continued movement towards NIH and success, and with any other trial you're still looking into.

– Kyle

Hi Artie,

I'm in one of the Bristol Myers Squibb phase I trials, Nivolumab + Lirilumab. I should get my 32nd biweekly dose next week. I know UChicago, where you went up to, is one of BMS's 5 special phase I trial sites. 

To add to your experiences, I was able to get into my phase I trial during the second "dose expansion" cohort that had 16 slots for melanoma (and additional 16 slots per 5 additional cancer types). All 96 of those slots opened at the same time. Whereas the prior, first "dose escalation" cohort was much smaller and I believe followed the same slow narrow on-boarding schedule you describe.

The bigger dose expansion cohorts didn't open up until the "maximum tolerable dose" / MTD was determined by earlier dose escalation cohorts. For a different phase I trial that I didn't get into, I spent a month waiting for it to get through the dose escalation phase. But that kept getting delayed each time someone had an adverse effect that needed to be examined. So I finally jumped at the first PD-1 trial that had an opening for me, which was this one in when I hit the "dose expansion" cohort timing just right.

Wishing you continued movement towards NIH and success, and with any other trial you're still looking into.

– Kyle

Hi Artie,

I'm in one of the Bristol Myers Squibb phase I trials, Nivolumab + Lirilumab. I should get my 32nd biweekly dose next week. I know UChicago, where you went up to, is one of BMS's 5 special phase I trial sites. 

To add to your experiences, I was able to get into my phase I trial during the second "dose expansion" cohort that had 16 slots for melanoma (and additional 16 slots per 5 additional cancer types). All 96 of those slots opened at the same time. Whereas the prior, first "dose escalation" cohort was much smaller and I believe followed the same slow narrow on-boarding schedule you describe.

The bigger dose expansion cohorts didn't open up until the "maximum tolerable dose" / MTD was determined by earlier dose escalation cohorts. For a different phase I trial that I didn't get into, I spent a month waiting for it to get through the dose escalation phase. But that kept getting delayed each time someone had an adverse effect that needed to be examined. So I finally jumped at the first PD-1 trial that had an opening for me, which was this one in when I hit the "dose expansion" cohort timing just right.

Wishing you continued movement towards NIH and success, and with any other trial you're still looking into.

– Kyle

You are right, Artie.  Another thing to remember about Phase 1 trials…is that "technically" they are only done to determine dose.  Meaning:  How much of the treatment does it take to get an effect? And, how much of the treatment causes side effects in the patient?  Kyle is right about trial expansion.  In my Phase 1 Nivo (Opdivo) with peptide vaccine trial…we started with two arms…NED and non resected.  10 patients were admitted at each of the three dose levels, therefore 30 patients to each arm.  However, since then…expansion has been incredible….to include patients who were not given the vaccine (since it didn't help!!) and therefore cut down on admission limiting requirements of a particular HLA typing, to include patients who had had dose limiting side effects from prior ipi, to include Stage III NED patients as well as Stage IV….and on and on…all under the same "trial".  On the good side…in Phase 1 trials, for better or worse, every patient gets the medicine.  There is no placebo or administration of a recognized to be "less effective" med.  It is all pretty crazy.  Glad things are looking positive on your plans, Artie.  Good luck to you all.  Celeste 

You are right, Artie.  Another thing to remember about Phase 1 trials…is that "technically" they are only done to determine dose.  Meaning:  How much of the treatment does it take to get an effect? And, how much of the treatment causes side effects in the patient?  Kyle is right about trial expansion.  In my Phase 1 Nivo (Opdivo) with peptide vaccine trial…we started with two arms…NED and non resected.  10 patients were admitted at each of the three dose levels, therefore 30 patients to each arm.  However, since then…expansion has been incredible….to include patients who were not given the vaccine (since it didn't help!!) and therefore cut down on admission limiting requirements of a particular HLA typing, to include patients who had had dose limiting side effects from prior ipi, to include Stage III NED patients as well as Stage IV….and on and on…all under the same "trial".  On the good side…in Phase 1 trials, for better or worse, every patient gets the medicine.  There is no placebo or administration of a recognized to be "less effective" med.  It is all pretty crazy.  Glad things are looking positive on your plans, Artie.  Good luck to you all.  Celeste 

You are right, Artie.  Another thing to remember about Phase 1 trials…is that "technically" they are only done to determine dose.  Meaning:  How much of the treatment does it take to get an effect? And, how much of the treatment causes side effects in the patient?  Kyle is right about trial expansion.  In my Phase 1 Nivo (Opdivo) with peptide vaccine trial…we started with two arms…NED and non resected.  10 patients were admitted at each of the three dose levels, therefore 30 patients to each arm.  However, since then…expansion has been incredible….to include patients who were not given the vaccine (since it didn't help!!) and therefore cut down on admission limiting requirements of a particular HLA typing, to include patients who had had dose limiting side effects from prior ipi, to include Stage III NED patients as well as Stage IV….and on and on…all under the same "trial".  On the good side…in Phase 1 trials, for better or worse, every patient gets the medicine.  There is no placebo or administration of a recognized to be "less effective" med.  It is all pretty crazy.  Glad things are looking positive on your plans, Artie.  Good luck to you all.  Celeste 

Thanks for starting this thread Artie.  Good info posted by all.  Good luck with NIH.  I hope it works out for you.

Brian

Thanks for starting this thread Artie.  Good info posted by all.  Good luck with NIH.  I hope it works out for you.

Brian

Thanks for starting this thread Artie.  Good info posted by all.  Good luck with NIH.  I hope it works out for you.

Brian