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Ocular Melanoma Clinical Trials: What You Need to Know in 2025 · The Eye Believe Podcast

• 0:00
  hey everybody in today's episode
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  we are diving into the most up to date list as of today
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  which is May 5th 2025
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  and we are
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  recording this episode to talk a little about
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  the metastatic trials that are currently recruiting
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  in the United States
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  but there's some that are kind of other places too
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  so I'm joined today again with Doctor Pauline Funchain
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  who is a medical oncologist
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  dedicated to the uveal
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  melanoma patients in the Stanford area
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  and just you know
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  obviously wider California
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  so we're so glad to have you back
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  thanks for joining us Pauline
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  so glad to be back thank you for the invitation
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  okay so like I know some patients kind of feel like
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  why should I have to know this right
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  why should I have to
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  and we were just talking about this too
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  like as a doctor you're like oh
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  like I wish that patients
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  didn't have to learn this information
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  but let's just chat a little about why is it important
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  as you were saying you know
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  we before this
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  we're talking about all the
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  the things that are really good for patients to know
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  who are looking for clinical trials
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  and that I I really wish it weren't so complicated
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  I mean it is not easy
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  you can do Google searches and all of those things
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  and you'll find things old trials
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  new trials you know
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  but to actually find trials that are um
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  current and relevant um
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  in fact before we did this I
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  I was just looking cause I
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  you look for fun to see what
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  what patients might find for a Google search and
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  you know of course um
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  there were all these trials
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  that weren't relevant to the metastatic space
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  there were trials that weren't um
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  that weren't even relevant for uveal melanoma
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  they were other types of melanoma
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  and so it's really hard to parse through all of this
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  right so there's
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  I think a couple of key things that are important to
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  to look for um
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  in terms of trials but honestly
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  honestly um
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  you know
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  those of us who are in the clinical trial space
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  are
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  more than happy to walk a patient through all of this
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  it can be really a lot to do it on your own and
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  and honestly um
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  I get it you want to do it on your own
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  because you want to be a part of it
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  you want to be part of the
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  you know um
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  of the team and we want you to be part of the team
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  and every now and then uh
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  patients find things that we don't find right
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  um particularly
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  and I here's where
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  where this really becomes important
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  is if your main doctor is not a doctor
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  who specializes in uveal melanoma
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  and is not a doctor who specializes in um
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  clinical trials in uveal melanoma
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  they may not know all of the trials that are out there
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  um and even even if your doctor specializes
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  every now and then
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  there's a trial that's only at one place
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  and you don't necessarily hear about that right away
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  um so I think we can do it together
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  those of us who do uveal melanoma and do uveal
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  melanoma trials are more than happy to
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  sort of pick apart the
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  sort of haystack that is the internet but
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  but those are some sort of the experiences of
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  of looking through um
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  in terms of clinical trials
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  um specifically for uveal melanoma
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  no I think those are all such good points
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  and I'm glad you brought all of those up
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  I honestly can't really say that
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  I have much to add to that
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  because I feel like you hit the nail on the head
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  and just to reiterate
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  like it is so important if you can
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  for you to be seen either virtually or in person
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  and just be followed by a uveal
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  melanoma medical oncologist
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  that's gonna be someone who specializes in uveal melanoma
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  not just melanoma in general
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  because as you probably found in the Google search
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  Pauline like if you Google uveal melanoma trials
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  all the melanoma ones that could possibly come up
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  also come up
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  which is very confusing and hard to parse through
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  like just very difficult
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  so I love that you brought that up too
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  that like the the doctors who are here um
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  and who are in this space are very dedicated
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  like Doctor Funchain
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  and like so many others across the country
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  we do have like some really good specialists
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  who are actively researching uveal melanoma
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  and who are actively working to expand
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  trial access for patients
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  and so just keep that in mind
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  that if you don't have one of those doctors
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  they do exist and they do exist all around the country
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  from the Midwest to the west
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  all the way across to the East Coast
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  like we've got doctors all over
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  so if you need help finding one of those doctors
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  please reach out to us and and honestly
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  like if you know of a doctor like Doctor Funchain
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  but say you live on the East Coast
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  and you're not really sure where to go
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  I'm positive like just knowing Doctor Funchain
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  that she would
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  refer you to someone that she would recommend
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  on the other side of the country
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  if needed
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  and I think most of the doctors that I know of who
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  you know treat uveal melanoma patients
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  also would do that as well um
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  so okay food for thought
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  we've got you know recruiting clinical trials
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  so a recruiting clinical trial
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  my goodness this is gonna be fun words
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  is one that is actively like
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  looking for patients to join
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  and to be a part of that trial
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  so the challenging thing is a patient right
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  like I've been in this space for almost five years now
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  of just learning and just seeing what's happening
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  and one of the challenging
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  maybe a little bit discouraging
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  things that happens is that over time
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  we see lots of trials right
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  like I think even last year
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  the year before there were maybe like 10 to 12 ish
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  and that was maybe the most recruiting clinical trials
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  I had ever seen on a list
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  and then we have years like that are only five or six
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  or that are only you know
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  I'm sure that historically
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  there used to even be times
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  that there was maybe only one or two
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  and like that can feel
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  really defeating to both doctors and to patients
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  so we just wanna
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  I guess I wanna just emphasize that today
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  this is a snapshot in time right
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  this is a snapshot for what's happening right now
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  but in a couple months
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  this could be a little bit different
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  there could be more sites open
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  there could be um
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  more trials
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  that show up in the list of actively recruiting trials
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  so you know
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  as a patient like if you have scans
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  say every three months or maybe every six months
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  like maybe your job is just to check in and be like
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  hey doctor
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  so and so
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  like is there anything new at your next follow up
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  um and just make sure that you kind of keep in the loop
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  even if you don't need it yet
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  just so that you're aware of kind of how the space
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  changes and oscillates
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  because it does change it kind of goes up and down okay
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  so Pauline do you have anything to add to that
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  I think
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  it's really important to know that trials change
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  and change often
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  that's been actually good for uveal melanoma
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  uveal melanoma you're right
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  like it really there were only a handful of trials
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  um you know
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  maybe even five years ago
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  and just recently
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  there has been a lot more interest in
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  uveal melanoma and you know
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  thank you to the companies out there
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  who are jumping into the space
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  um but these things do
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  many of them will open accrue
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  a certain number and then close
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  or they will open
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  and then be on some regulatory hold because of the FDA
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  and it looks like it's open
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  but it's not open so these things are very dynamic
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  it is really good to keep in touch
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  and sometimes
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  if you're not necessarily thinking about a trial now
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  but you're thinking about something in the future
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  um certain trials will allow certain things
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  so you may want to
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  you may want to just have that conversation
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  with an oncologist about
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  if I do X or y you know
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  is this important to me in the future
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  for doing a trial next or doing a trial now
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  or you know
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  there's a little bit of trying to order
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  what you're doing so that we can maximize the
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  the amount of therapies that are available to you
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  so it's always nice to have that conversation yeah
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  for sure okay so
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  before we zero in on those current active recruiting
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  clinical trials for uveal melanoma
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  let's just talk about a couple of like
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  key information pieces that we should pay attention to
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  when we're researching
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  so you guys like get your notebooks
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  let's just like take some notes
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  just so that you understand what are these
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  these kind of key factors are just the
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  the keywords maybe
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  that you might want to understand
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  when you're looking at a clinical trial um
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  or looking for one so
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  Doctor Funchain what is a an NCT number
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  like why is that relevant and useful
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  oh yeah yes hahaha nct numbers um
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  so those are the unique
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  it's a unique number for a trial
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  just like you know
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  a social security number for you
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  or driver's license number
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  whatever it is but that is a unique number for a trial
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  so if you have that number
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  you know exactly which trial it is
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  sometimes if you're searching by
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  let's say name of the drug
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  you're gonna get different trials
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  there's a trial for first line
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  there's a trial for adjuvant
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  it might not be the right space where your um
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  uveal melanoma treatment uh
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  spot in time is so
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  it's kind of important to actually get
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  the specific name because sometimes if you the
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  the name when you read a clinical trial name
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  it's like a long
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  it's like 10 words and multiple things
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  and a lot of medicalese
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  and so if you have that NCT number
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  it's much more specific
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  okay that makes sense
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  and so it's gonna help us like
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  zero in and make sure we're getting the right trial
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  for what we're looking for
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  not just like the general
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  I don't know like it
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  it just helps narrow it narrow the focus
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  I guess is what I'm hearing
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  um okay
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  so then who are like
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  what is when it says P.I. or primary investigator
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  what is that like who is the primary investigator
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  yeah so the primary investigators are the main
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  it's the main person
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  at each center that has the trial open
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  who is responsible for that trial
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  it may not be so if you're in a trial
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  it may not be your treating physician right
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  so there's only one person per site
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  so by site I mean like
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  you know a university or a hospital
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  so let's say Stanford is a site
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  I used to be at the Cleveland Clinic
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  that is a site you know these are all different sites
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  um if it's if there is more than one site
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  there usually isn't so if you were let's say
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  um being treated let's say at Stanford um
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  and there's an Emeryville
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  and there's a Palo Alto right
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  now for uveal melanoma for
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  for the most part what you're gonna find is
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  the treatment is at the main site
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  the main university site um
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  getting treated at a what we call a satellite clinic
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  but not the main um
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  place is less really really uncommon
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  just because uveal melanoma is a more rare tumor
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  and the people who are involved with uveal
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  melanoma are usually specifically on the main campus
• 10:29
  Castle Biosciences is a proud sponsor of this
• 10:32
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• 10:33
  Castle's innovative uveal melanoma tests
• 10:35
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• 10:36
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• 10:41
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• 10:44
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• 10:47
  so just be aware of that that's not totally true for
• 10:50
  let's say skin melanoma trials
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  there are certain
• 10:54
  skin melanoma trials that are at multiple sites
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  but in any case
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  the expectation is by knowing the
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  a primary investigator you know
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  who is responsible for that trial that it
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  that person and their team will know the most
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  about that trial
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  so if you are going to a health system that
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  where you don't necessarily
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  know who you need to talk to
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  that's a great place to start okay
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  um alright
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  so then what about the company funding the trial
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  sometimes this information is known
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  I think it kind of
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  maybe just depends on how you find the information um
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  I know if you're looking through clinical trials
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  that we at A Cure In Sight
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  share with you guys like through our newsletter
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  like you're gonna know if it's um
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  you know associated with Aura Biosciences or uh
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  I'm trying to think Immunocore
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  or like just different other
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  the other different sponsors that we have
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  that are just helping us as an organization
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  to make sure that
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  we get good information out to patients
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  and in turn you know
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  we help them make sure that
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  that patients are up to date about press releases
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  like data that they have released
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  um maybe at ASCO
• 11:57
  and we also try to help make sure that people know
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  if they have a new site
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  or if they're just currently recruiting again
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  for their trial um
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  so why do you think it's important to
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  you know have a background or
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  you know
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  have any level of understanding of who the company is
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  that's funding the trial
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  yeah this
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  this is where we were talking before
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  I was just you know
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  all of these details I
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  I just wish patients didn't have to wade through
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  I think you're a more you're a more prepared patient
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  if you have all of these pieces of information
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  for sure
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  but you know
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  especially if you're in places where there are not
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  where there isn't a uveal melanoma specialist nearby
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  who really knows a lot about uveal melanoma
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  having each and every
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  bit of these pieces of information
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  so the NCT number um
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  who the primary investigator is
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  the next nearest site to you
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  and who the company is that's sponsoring
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  it can really help so in the case of um
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  knowing the company sometimes if
• 12:59
  if you don't have a a link to a
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  um primary investigator or a
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  or a specific site
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  you can actually find out more information
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  from the company
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  they sometimes have patient advocates or navigators
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  who can help you
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  with more information
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  where to find the next nearest site
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  who the investigator is and
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  and in some cases they can help with um
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  they they will
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  actually have people who will help with reimbursement
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  for trials and things like that
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  so it's not not every um
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  trial has extra reimbursements
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  but sometimes they do and sometimes you do actually
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  end up interacting directly with the company
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  okay so really good points right
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  um I have a couple of follow up questions
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  um I've like
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  come in contact through the clinic that I go to um
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  and I'm sure some other patients have
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  just kind of depending on the center you go to um
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  but
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  I've come in contact with someone who calls themselves
• 13:57
  an oncology nurse navigator
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  um what's the role of a nurse navigator
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  in clinical trial care like at
• 14:03
  you know say Stanford or a unique center
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  yeah so nurse navigators are
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  are a patient's best friend
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  they're also a doctor's best friend to be honest yes
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  but you know nurse navigators are um
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  nurses who guide a patient through their treatments
• 14:24
  where to go what
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  you know what scans are next
• 14:27
  they're sort of the the main point person
• 14:29
  for all the logistics of what you're doing right
• 14:32
  your doctor is looking at all your test results and um
• 14:35
  looking at you and you know
• 14:37
  talking to you to understand where you are in life
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  and then putting that all together to make a plan
• 14:42
  the nurse navigator is kind of the person who's
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  helping to ex help
• 14:46
  helping you execute that plan
• 14:48
  I often call them the air traffic controllers
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  they kind of know all the different pieces of
• 14:54
  where you should be landing
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  and at what time and
• 14:56
  you know um
• 14:57
  which airport and and that kind of thing so
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  so they they are gold um
• 15:02
  in every cancer center we should
• 15:04
  I wish we had twice as many of them
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  at every cancer center yeah
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  for sure and there are
• 15:10
  and they will help so they help with um
• 15:13
  a lot of trials involve standard of care things
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  so the drug itself may be experimental
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  but the um
• 15:21
  the scan is a normal scan
• 15:22
  that goes through your normal insurance
• 15:24
  and that kind of thing and so your um
• 15:27
  nurse navigator is someone who can schedule that scan
• 15:30
  you know make sure that you have the time
• 15:33
  make sure that all the financial
• 15:34
  people have the information
• 15:35
  they need to get that scan um
• 15:37
  paid for and there are um
• 15:40
  specific nurse navigators that actually are in trials
• 15:43
  so they actually can walk you through all of the um
• 15:47
  trial specific things
• 15:49
  and sometimes the nurse navigators
• 15:50
  sometimes you'll have a clinical trial nurse navigator
• 15:54
  sometimes you'll have a standard of care
• 15:55
  nurse navigator and sometimes you have both
• 15:57
  sometimes they work together okay
• 15:59
  so you mentioned this a little bit right
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  you touched on a little bit of this
• 16:03
  this topic
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  but do clinical trials get covered by health insurance
• 16:07
  and who helps to navigate the health insurance
• 16:09
  for the patient yes
• 16:11
  so um yes
• 16:13
  this is a fabulous question we um
• 16:17
  try to make sure to talk about this
• 16:18
  every time we talk about a trial
• 16:19
  because this is something um
• 16:21
  patients need to know so the
• 16:23
  the whole thing about trials is
• 16:25
  the part of the trial that is experimental
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  is paid for by the trial so if there is
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  so an experimental drug is paid for by by trial um
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  any blood tests that are done because this is to help
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  sort of help the science of the drug
• 16:44
  that is paid for by the trial any
• 16:47
  if that normally you would get scans every three months
• 16:52
  um but this trial wants scans every six
• 16:56
  every six weeks then the sort of unnecessary um
• 17:00
  scans from a from a standard of care point of view
• 17:05
  those are covered by trial um
• 17:07
  but things that you would normally do
• 17:11
  that wouldn't be part of a trial
• 17:12
  so you would normally get scans every three months
• 17:15
  or you would normally
• 17:16
  see a physician every three months
• 17:17
  that kind of thing those will get billed to insurance
• 17:22
  so they're covered the way your insurance covers them
• 17:26
  so if your insurance totally covers your scans
• 17:29
  then you those scans are totally covered
• 17:31
  if your insurance only pays 50% of scans and
• 17:34
  you know the rest of it
• 17:35
  it you know
• 17:36
  goes to a deductible or whatever
• 17:38
  that's how it goes for the standard of care parts of it
• 17:40
  but anything that is additional that the
• 17:43
  the standard of um
• 17:45
  that the experimental drug adds is covered by the trial
• 17:50
  okay does that answer the question
• 17:52
  yeah that totally does
• 17:52
  and I think this also just illustrates
• 17:54
  how important an oncology nurse navigator is
• 17:57
  especially in the clinical trial space
• 17:58
  because I'm sure that they're really helping to
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  you know
• 18:01
  orchestrate all of the behind the scenes pieces of like
• 18:03
  what gets built insurance
• 18:05
  and when
• 18:06
  that's I
• 18:07
  I will say that is often um
• 18:09
  partially the the nurse navigator
• 18:11
  in that
• 18:12
  the nurse navigator handles the standard of care stuff
• 18:14
  but it is also partially the clinical trial team
• 18:18
  so it's actually the clinical trial team
• 18:20
  there's usually someone who's designated to name
• 18:23
  I mean this is why
• 18:24
  this is why trials get really expensive to
• 18:28
  to do but there's like
• 18:29
  literally someone who sits there and is like that
• 18:32
  you know of that 102 things that you do
• 18:35
  you know in terms of tests and vital signs
• 18:38
  and like every little piece of it
• 18:40
  they're like this gets built to trial
• 18:42
  this gets built to standard of care
• 18:43
  this gets built to trial
• 18:45
  and then pushes all the paperwork
• 18:46
  to the right space oh my gosh
• 18:48
  so it is it's complicated
• 18:49
  you hopefully don't have to see it
• 18:51
  but it's good to know that
• 18:52
  it's happening in the background yeah
• 18:54
  because occasionally you know
• 18:56
  there's gonna be something that
• 18:58
  either gets put in the wrong place
• 18:59
  or there's a question about where it goes
• 19:01
  and you may hear about it as a patient
• 19:03
  so it's kind of nice to know that
• 19:05
  that happens in the background yeah
• 19:08
  well and I know too
• 19:08
  that like sometimes
• 19:09
  understanding our insurance is a whole full time job
• 19:12
  as a patient as well
• 19:14
  and like we don't need to dive in too much to that
• 19:15
  but I know that sometimes it can
• 19:17
  especially for a rare disease space
• 19:19
  I know like just looking at my insurance
• 19:21
  most of the time anything
• 19:22
  rare disease focused isn't really gonna come up in my
• 19:25
  like insurance benefits right
• 19:27
  so like there is a spot in my insurance
• 19:29
  that says something about
• 19:30
  you know patients can do clinical trials
• 19:32
  the challenge is that it only says a specific
• 19:34
  you know cancer type and so then it's like okay
• 19:37
  but what about the other
• 19:38
  like hundreds of types of cancer
• 19:40
  or you know like how do how do we do that
• 19:42
  and so it's it's helpful to know I think that you know
• 19:45
  the medical team the clinical trial team
• 19:47
  everybody
• 19:47
  works together to just make sure that this is
• 19:50
  really as little of a burden on the
• 19:51
  patient as possible
• 19:53
  because they are actively participating in
• 19:55
  you know in the research study
• 19:56
  which is a huge um that's a huge feat in and of itself
• 19:59
  yeah I mean
• 20:00
  I'll say there as somebody who's on a trial
• 20:03
  you'll feel like a lot of hands are in the pot
• 20:06
  and there's a lot of cooks in the kitchen
• 20:09
  but I I will say the plus to that honestly
• 20:12
  is that clinical trial patients
• 20:14
  you know I think it's very fair to say
• 20:16
  clinical trial patients
• 20:18
  are monitored much more closely
• 20:20
  and there are a lot more eyes on what happens to
• 20:24
  to a clinical trial patient in terms of um
• 20:27
  side effects
• 20:27
  in terms of response in terms of the billing
• 20:30
  so it's a little bit more complex
• 20:32
  but it's a lot more people who are watching you
• 20:35
  and I actually like that a lot
• 20:37
  there's a lot of safety to that in terms of um
• 20:41
  medical safety and financial safety
• 20:44
  mm hmm
• 20:45
  okay so kind of two
• 20:48
  I guess two main questions
• 20:49
  before we get to the list of trials that are currently
• 20:51
  recruiting right now
• 20:52
  so promise you guys those are coming
• 20:54
  keep a lookout get your notebooks ready um
• 20:56
  we are gonna be talking about that but um
• 20:58
  what do you think are some of the main barriers
• 21:00
  or even motivating factors that
• 21:02
  have patients choose to participate in a
• 21:04
  you know in a clinical trial or not
• 21:07
  um in your practice or otherwise
• 21:08
  just kind of what you see yeah um
• 21:11
  so one of so let's do barriers first
• 21:14
  so barriers I think one of the main barriers is travel
• 21:16
  yeah um
• 21:18
  clinical trials
• 21:19
  usually involve a couple of extra visits
• 21:22
  especially on the front end to make sure that
• 21:24
  that a patient is safe going into a trial
• 21:27
  um but then there's also a lot
• 21:29
  some of these experimental regiments can be
• 21:33
  you know every two weeks
• 21:34
  in some cases every week um
• 21:37
  and all that travel is um
• 21:41
  it's a lot it's a lot of parking
• 21:43
  it's a lot of gas it's a lot of time
• 21:47
  time away from work it's all of those things
• 21:50
  so I think that that
• 21:51
  that is one of the barriers um
• 21:54
  you know
• 21:55
  I think some companies will try to defray the costs
• 21:58
  of some of these things
• 21:59
  there are some trials that do support travel um
• 22:03
  and some academic centers that
• 22:06
  that have a little bit more room to support travel
• 22:08
  so those are good things to know um
• 22:11
  but ultimately you know
• 22:12
  the the
• 22:12
  the time that it takes that's not something that
• 22:14
  that we're um
• 22:17
  there's not a way to defray that
• 22:18
  it's just a commitment yeah
• 22:20
  so so it's
• 22:21
  it's one of those things to know um
• 22:23
  I think another barrier is um
• 22:26
  randomization
• 22:28
  so that doesn't happen in a lot of trials
• 22:31
  but if it's an exciting trial
• 22:33
  randomization is happening
• 22:34
  so the most exciting trials I think are the
• 22:36
  the trials that are um
• 22:38
  are where there's a drug that we really think there is
• 22:41
  we've seen efficacy we've seen that it's decently safe
• 22:44
  in terms of side effects
• 22:45
  these are the phase 1 and 2 trials
• 22:47
  and then in the phase 3 trial
• 22:48
  we are trying to see if this drug is good
• 22:50
  enough to make it to market
• 22:52
  which is pretty exciting because that means that that
• 22:54
  that you feel pretty safe
• 22:55
  that there's some good data behind it
• 22:57
  mm hmm um
• 22:58
  but then the the cost of
• 23:00
  of being at sort of the
• 23:02
  the cutting edge of almost approved drug is that
• 23:06
  most of the time these trials are randomized which
• 23:09
  so randomization is a way to make sure that we
• 23:13
  that um
• 23:15
  we actually know this drug is making a difference
• 23:18
  over the next best thing right
• 23:20
  so whatever is the next best thing
• 23:22
  or the thing that is currently the standard of care
• 23:25
  we need to compare the new thing to that
• 23:28
  and make sure it's better
• 23:30
  and the only way we can do that faithfully
• 23:33
  is to take half of the people
• 23:34
  and put them on the experimental drug
• 23:37
  and half of the people and put them on
• 23:38
  what we would normally give for standard of care
• 23:41
  um and the only way to fairly do that is to
• 23:44
  essentially flip a coin and um
• 23:46
  which means that when you walk into a trial
• 23:49
  sometimes you're faced with the
• 23:51
  not being able to choose what your drug is gonna be
• 23:54
  whether it's gonna be the experimental drug or the the
• 23:58
  um standard of care drug and that sort of
• 24:04
  um I mean it's
• 24:05
  it's not very long but it's
• 24:06
  you know a week or a couple of days or whatever
• 24:09
  where you're waiting to see what your fate is
• 24:13
  and it's based on the flip of a coin
• 24:14
  and not based on your decision making
• 24:18
  you know cancer is a lot about um
• 24:23
  managing your sense of control of your life um
• 24:27
  you know
• 24:28
  as much as you are in so much control of your life
• 24:31
  for every other thing
• 24:32
  to not have control over this thing called cancer
• 24:37
  it's a huge burden for patients
• 24:39
  and to put on top of that
• 24:40
  like you're gonna do a flip of a coin
• 24:43
  it's difficult I
• 24:44
  I fully realize as a human being
• 24:46
  that is a really difficult thing to do
• 24:49
  um as a scientist and doctor
• 24:51
  that wants to see these drugs go forward
• 24:53
  so that so that
• 24:54
  our patients going forward can have access to cool
• 24:57
  new things you want randomization to
• 25:00
  you wanna minimize that emotional aspect of it
• 25:03
  but it's there and that can sometimes be a barrier um
• 25:08
  so so that's barriers um
• 25:10
  and then can I ask
• 25:11
  can I ask you a question about this one
• 25:12
  this specific barrier um
• 25:14
  yeah yeah yeah
• 25:14
  I'm yeah
• 25:15
  this has just been something that's come up for me
• 25:16
  and I don't know about you guys
• 25:18
  if you've seen you know
• 25:19
  medical dramas on TV or just movies
• 25:21
  like a lot of the times when we see things in the media
• 25:24
  talking about clinical trials
• 25:26
  there's this aspect of randomization
• 25:28
  but there's also the blinded aspect of it
• 25:31
  I have yet to see that blinded
• 25:33
  like a blinded trial for uveal melanoma
• 25:35
  and yeah and I'm curious
• 25:38
  if you have any insights as to why that is
• 25:40
  because I guess as a patient
• 25:42
  just from a mindset perspective
• 25:43
  I feel like it would be so much more defeating
• 25:45
  and in my brain I feel like it even
• 25:47
  maybe could influence the data in a negative way
• 25:50
  um
• 25:50
  to say that the standard of care is what you're getting
• 25:52
  and so you know
• 25:53
  like oh yeah
• 25:54
  you know
• 25:54
  you're not getting the trial drug that you wanted
• 25:57
  and on top of that
• 25:59
  like if you are participating in the trial
• 26:01
  if that's mentally and emotionally defeating to you
• 26:03
  then you know
• 26:04
  if the placebo effect
• 26:05
  which we've seen studied in so many things in science
• 26:07
  is real
• 26:08
  then wouldn't it potentially have the opposite effect
• 26:10
  where it would maybe make it so that there's
• 26:12
  the potential for the outcomes to be worse
• 26:14
  for the standard of care than they might be
• 26:16
  if they were a blinded trial
• 26:18
  and everybody just thought they were getting the drug
• 26:20
  like regardless this is such a good question
• 26:22
  and I'm actually really
• 26:24
  kind of thrilled you asked it that way
• 26:26
  because most people um
• 26:29
  get frustrated by blinding and are like
• 26:32
  I mean I'm over here just like
• 26:34
  excuse me tell me that I'm getting everything
• 26:36
  and don't tell me that like
• 26:38
  tell me I'm randomized
• 26:39
  but also tell me I get the drug no matter what
• 26:41
  don't tell me if I don't like yeah
• 26:44
  because I will think and I would rather
• 26:46
  rely on my brain to help my body in any way
• 26:48
  shape or form than anything else yeah
• 26:52
  you know honestly
• 26:54
  it had never occurred to me that that that um
• 26:57
  there's there might be a positive placebo effect
• 27:01
  um for
• 27:03
  you know both arms
• 27:04
  but who cares if it's positive for patients
• 27:06
  it's positive for patients for randomization
• 27:08
  um I honestly had not thought about it that way
• 27:10
  I mean I
• 27:11
  I have been a
• 27:12
  I have been a investigator in a blinded trial
• 27:15
  um as an invest from the investigator side
• 27:18
  you're just like oh you
• 27:19
  it's so obvious who's who's on or not on
• 27:22
  I mean it's not that obvious
• 27:24
  but you you tell yourself
• 27:26
  but if they find a way to make it comparable
• 27:28
  right like
• 27:29
  if they find a way to make it convincingly comparable
• 27:32
  then I think the placebo effect could be real
• 27:34
  but yeah you know
• 27:36
  that's yeah
• 27:36
  kind of well so
• 27:36
  so this is the the um
• 27:39
  the randomized trial that I'm thinking of involved
• 27:41
  so the experimental drug was an injection drug and the
• 27:47
  um
• 27:48
  the standard of care was just plain old immunotherapy
• 27:51
  so then everyone ended up having to get injected
• 27:55
  hmm but you didn't know
• 27:58
  you didn't know whether you were injecting real or not
• 28:01
  and so then you kind of felt bad for patients who were
• 28:04
  you're like gosh
• 28:05
  if you're getting you know
• 28:06
  sham injection
• 28:08
  it's just like a lot of pokes for no reason
• 28:11
  and you can imagine in uveal melanoma
• 28:14
  the standard of care is is going to be at least for um
• 28:18
  for the metastatic setting you
• 28:20
  that that will be um
• 28:21
  Tebby which is once a week
• 28:23
  so sorry Tebentafusp
• 28:25
  or Kimmtrak
• 28:26
  but that is a once a week drug
• 28:28
  and so you may be comparing um
• 28:31
  you may be making people come in to a once a week
• 28:34
  placebo when the actual drug is once every three weeks
• 28:38
  or something like that
• 28:39
  then you'd feel really bad about that
• 28:41
  so
• 28:41
  we feel sort of guilty bringing you guys in for either
• 28:45
  um unnecessary injections
• 28:47
  or even unnecessary infusions of placebo um
• 28:51
  knowing that half of the people are getting placebo
• 28:54
  so we I guess our perspective is like oh
• 28:57
  we're like we're
• 28:58
  we're um
• 29:00
  inconveniencing the patient
• 29:02
  but it's really interesting to hear the opposite to say
• 29:05
  but hope is not an inconvenience
• 29:07
  that's very interesting well
• 29:10
  that's I mean
• 29:10
  but you also bring up really good points too
• 29:12
  that like you know
• 29:13
  the goal of medicine is do no harm right
• 29:15
  and if you're having to kind of fake the injections
• 29:18
  and you're doing an injection
• 29:20
  like for example I know there's one trial
• 29:22
  I'm thinking of for uveal melanoma
• 29:24
  where they're injecting a specific tumor or two or
• 29:26
  you know however many
• 29:28
  and the the comparative arm is um
• 29:31
  I think it's an immunotherapy
• 29:32
  like a weekly or a maybe a
• 29:34
  a periodic immunotherapy drug
• 29:36
  and there's no way to to do that without causing
• 29:40
  you know unnecessary harm to the patient in some degree
• 29:42
  like at least arguably
• 29:44
  so I can see why that might be part of it
• 29:45
  but I agree with you too
• 29:46
  that like hope is not something that we should discount
• 29:49
  yeah um
• 29:50
  yeah and I
• 29:51
  I kind of I guess
• 29:52
  I just wish that maybe there was a little more
• 29:55
  availability in the space for that discussion
• 30:28
  so maybe you know
• 30:29
  any of any of our wonderful sponsors listening yeah
• 30:31
  take that into consideration as you
• 30:33
  as you model your trials and format everything
• 30:36
  um it's true
• 30:37
  I mean it
• 30:38
  a lot of people I think as sponsors in general
• 30:41
  um try to side step it because it's expensive right
• 30:44
  it's expensive to put on sham um
• 30:46
  infusions or sham injections
• 30:48
  so sponsors well
• 30:50
  and I mean I can see that from you straight
• 30:51
  heard it straight from the patient's mouth or the yeah
• 30:53
  the participants
• 30:54
  that you would like to be on your trials
• 30:57
  like think about it but
• 30:58
  but that's you know
• 30:59
  we could argue that's another barrier
• 31:00
  just in general to UV melanoma is just the funding
• 31:03
  right the funding for the trials is gonna be
• 31:05
  it's gonna be less these are smaller companies and
• 31:08
  and I do want to
• 31:08
  just give a quick plug to these kinds of companies who
• 31:11
  many of them are our sponsors for our podcast
• 31:13
  and our YouTube channel um
• 31:15
  they're you know
• 31:16
  a part of the reason that we
• 31:17
  that we partner with them
• 31:17
  is because they're the ones doing the research
• 31:19
  and
• 31:20
  just helping to move things forward to clinical trials
• 31:22
  and beyond so
• 31:24
  we just want to make sure that you
• 31:25
  guys are in the know as much as possible
• 31:27
  we stay in contact with these pharmaceutical reps
• 31:29
  and they are like like we talked about before
• 31:31
  they've got wonderful patient advocate programs
• 31:34
  in most cases and if they don't
• 31:36
  then they're working on having one
• 31:37
  and they're just really all very caring people
• 31:40
  like every person that I've ever met
• 31:41
  from any of these pharma companies
• 31:43
  they all really
• 31:43
  care deeply about the outcome of patients
• 31:45
  and they want to see you know
• 31:47
  their drugs succeed and help patients to
• 31:49
  you know live longer and to survive and
• 31:51
  and to have better outcomes in uveal melanoma um
• 31:54
  so just know that those people
• 31:56
  like the people behind the
• 31:57
  you know
• 31:57
  the banners that say whatever bioscience is like
• 32:00
  they are they are people who care about you um
• 32:03
  and they're doing the best that they can
• 32:04
  with all of the red tape
• 32:06
  and all of the things that they have to deal with right
• 32:08
  um so goodness
• 32:12
  I guess
• 32:13
  the last question I have before we move to our list is
• 32:15
  how do doctors stay in the know
• 32:17
  like this information changes a lot
• 32:18
  so what do you as a doctor have to do to like
• 32:21
  make sure you stay up to date
• 32:23
  um I'm gonna
• 32:25
  I'm gonna put a pin on that
• 32:26
  because we did talk about all the obstacles
• 32:28
  you're right we talked about the obstacles
• 32:29
  I do want to talk about the motivating factors
• 32:32
  because there are good things about trials right
• 32:33
  thank you so I forgot about that
• 32:36
  oh it's all good
• 32:37
  I just you know
• 32:38
  we we talk about balancing balancing um
• 32:41
  the the realism and all the facts and we also um
• 32:45
  hope is a big deal and there are good facts to know
• 32:48
  and so we wanna make a a balanced discussion um
• 32:50
  so I'm all good with that um
• 32:52
  so in terms of motivating factors
• 32:55
  so despite things like um
• 32:57
  travel and transportation and um
• 33:00
  you know uh
• 33:02
  things like randomization
• 33:04
  patients still uh
• 33:05
  really want to be on trials
• 33:07
  I think they want to be on them as much
• 33:11
  for the same reasons that we
• 33:13
  as physicians want to have trials available
• 33:16
  and that is uh
• 33:18
  we all want to move the needle forward
• 33:23
  we all want new drugs to be available and approved
• 33:28
  and um
• 33:29
  you know honestly
• 33:30
  new drugs are a source of hope
• 33:33
  whether that drug ends up working or not
• 33:36
  in the long run
• 33:37
  it's still being on a trial is a huge sense of hope
• 33:40
  and I I
• 33:41
  I can't tell you how many patients we've had
• 33:45
  over the years who love being on a trial
• 33:49
  for the hope that it brings them
• 33:51
  it's something that that is usually not available
• 33:55
  other than what's on the trial
• 33:57
  so it's that a sort of ability to say
• 33:59
  this is what's normally available
• 34:00
  and I I have something that I
• 34:02
  that I can reach out and get
• 34:03
  that not everybody can reach out and get
• 34:05
  so there is that and then there's also
• 34:09
  there is actually some um
• 34:11
  altruism to it too
• 34:13
  I definitely have you know
• 34:15
  there's a subset of patients who really are like
• 34:17
  you know what
• 34:18
  it doesn't matter whether this trial ends up positive
• 34:21
  or not positive
• 34:21
  or whether it helps me or not
• 34:23
  you know I only have so much time on this world and um
• 34:27
  you know I'm on this trial to get more time
• 34:29
  but even if I don't get more time
• 34:31
  I know I'm helping the generations after me
• 34:34
  you know I could be helping a patient like
• 34:36
  you know a year from now with what I do
• 34:39
  and it's it's actually one of the most wonderful things
• 34:43
  um about what we do in oncology is seeing
• 34:48
  we see um
• 34:50
  you know we see people in their worst times
• 34:52
  but we also see people in their best times
• 34:54
  and sort of reaching out to the
• 34:56
  to the best of hope and optimism and giving um
• 35:00
  in them and so those are the things that really
• 35:02
  I think drive patients
• 35:04
  particularly when it's things like
• 35:05
  you know extra blood draws for research or whatever
• 35:08
  they're like that you know
• 35:09
  that feeling of knowing that
• 35:11
  that will go somewhere and help someone
• 35:12
  I think is is
• 35:14
  is really helpful but honestly
• 35:16
  um the
• 35:16
  the reason why we always
• 35:18
  as investigators want to have a
• 35:22
  as good of a sort of trial portfolio as possible
• 35:25
  is to give options to our patients
• 35:28
  um and a lot of options are options that are
• 35:30
  you know if it works
• 35:32
  it works and if it doesn't
• 35:33
  you know we got something else that we're gonna do
• 35:37
  well and
• 35:38
  and I think you know
• 35:39
  this is just something that
• 35:40
  that I tell myself as a patient
• 35:41
  you know
• 35:41
  considering clinical trials or just things like that
• 35:44
  in my own metastatic journey
• 35:45
  so if this helps you as a patient maybe
• 35:47
  maybe not but I love what Doctor Funtain just said
• 35:50
  but I also just want to add that
• 35:51
  you know one of the
• 35:53
  maybe
• 35:53
  important things to know about any clinical trial
• 35:55
  is that you have the right to say yes
• 35:57
  but you also have the right to change your mind
• 36:00
  um and that is something that helps me as a patient
• 36:02
  cause I I tend to be kind of one of those
• 36:04
  you know
• 36:04
  type a teacher pet kind of people who wants to like
• 36:07
  follow the instructions to the letter
• 36:09
  and so like there's a part of me that feels like
• 36:12
  you know if
• 36:12
  if say
• 36:12
  I were to do a trial the side effects were too harsh
• 36:15
  and I wanted to pull out
• 36:16
  like there's a part of me that might
• 36:18
  you know feel a little defeated and
• 36:19
  and feel almost like bad or guilty for that
• 36:22
  but I think it's so important that we
• 36:23
  as patients recognize
• 36:24
  that it's really okay for us to change our mind
• 36:27
  and that our doctors can and
• 36:29
  and do support us changing our mind if needed or
• 36:31
  you know if
• 36:32
  if something comes up in our personal life
• 36:34
  just whatever is going on yeah
• 36:36
  we're all doing the best that we can
• 36:37
  to move the needle forward
• 36:38
  in whatever ways we can and with the time that we have
• 36:41
  right
• 36:42
  absolutely
• 36:44
  okay well
• 36:45
  I'm glad we touched on the motivating factors
• 36:47
  because you're right that is so important
• 36:49
  and I'm so sorry that I glossed over that for a minute
• 36:52
  just uh
• 36:53
  I guess let's go into the list
• 36:55
  I think let's go into the list
• 36:56
  and then we'll cover our last question or two
• 36:58
  as we end but guys
• 37:00
  get your notepads ready get your pens out
• 37:02
  maybe screenshot any of the little like
• 37:04
  blips that are gonna pop up
• 37:05
  and just know that we're not gonna be
• 37:07
  going into detail about all of these trials
• 37:09
  and like covering you know
• 37:10
  what does this study do um
• 37:12
  we're gonna we're gonna just kind of highlight
• 37:13
  here's the ones that are ready to go
• 37:15
  and the ones that we know of today
• 37:17
  with a brief summary of like how
• 37:19
  you know what
• 37:19
  what should you know about this
• 37:20
  like is it liver directed
• 37:21
  is it systemic like things like that
• 37:23
  um so um
• 37:25
  let's just start with our metastatic trials
• 37:28
  and keep in mind guys
• 37:29
  there are also adjuvant trials and neo adjuvant trials
• 37:33
  which Doctor Funchain and Doctor Mruthyunjaya
• 37:34
  covered in a previous podcast episode
• 37:37
  so if you head back a couple episodes
• 37:39
  like I don't know
• 37:40
  a month or so back
• 37:40
  you should be able to find one of those episodes
• 37:42
  as well um
• 37:43
  okay so Doctor Funchain
• 37:44
  what's up on number one
• 37:46
  alright so we have um
• 37:50
  a study that is the um
• 37:53
  Darovasertib Crizotinib trial
• 37:56
  um you know
• 37:57
  just in our conversation um
• 38:00
  we had talked about having NCT numbers
• 38:02
  so let me I guess I'll pop up right yes
• 38:06
  they're gonna pop up so if yes
• 38:07
  if you wanna read it out loud
• 38:08
  that's fine
• 38:09
  but if you wanna just refer to the drug name
• 38:11
  and then the I D E
• 38:12
  or you know like the
• 38:13
  the kind of abbreviated name
• 38:14
  then that's fine too okay
• 38:16
  alright so so
• 38:18
  so let's start with the um
• 38:20
  Darovasertib Crizotinib trial um
• 38:22
  that is Darovasertib also known as IDE
• 38:25
  0 9 6 um
• 38:26
  so that I think is um
• 38:30
  a first line trial that has been um
• 38:32
  a long time in the making
• 38:35
  um and we have seen this uh
• 38:39
  combination work um
• 38:42
  pretty well at at
• 38:44
  um shrinking tumors
• 38:45
  um in the any stage metastatic setting
• 38:50
  and now
• 38:52
  this particular trial is bringing this combination
• 38:55
  into the first line so
• 38:56
  the very first thing that you essentially consider
• 39:01
  with a new diagnosis of metastatic uveal melanoma
• 39:05
  um it is very specific
• 39:07
  so it it does not allow any
• 39:09
  any prior um
• 39:11
  systemic treatment so if you've already had um
• 39:16
  if you've already had um Tebentafusp or um
• 39:20
  Ipi nivo or you know something that is
• 39:22
  goes all through the body um
• 39:25
  that will not count um
• 39:27
  you're you would not be eligible for the study
• 39:30
  um they also are allowing um
• 39:33
  they are allowing prior liver resection and prior liver
• 39:37
  um focal liver ablation
• 39:39
  but something that is regional
• 39:41
  like a Y90 would not count or you
• 39:45
  you would not be eligible
• 39:47
  so this is really front does this work
• 39:51
  um as the sort of first step
• 39:54
  so that is a Darovasertib Crizotinib study
• 39:56
  okay so that's our first one
• 39:58
  and then what's the next one up next on the list
• 40:01
  so next on the list then is the RP2 study
• 40:06
  um so this is an injection study
• 40:10
  the idea is that um
• 40:12
  there has been some data showing that injection of RP2
• 40:17
  which is a which is a an engineered virus
• 40:23
  but it is uh engineered to um
• 40:27
  only to only infect and kill tumor cells
• 40:32
  it doesn't um kill normal cells
• 40:36
  and it does release some sort of pro
• 40:39
  immune signals to help with tumor kill
• 40:43
  and tumor recognition in addition
• 40:46
  so this trial is requires a place that is injectable
• 40:52
  so if the tumor is you know
• 40:54
  way deep in the liver
• 40:55
  and you couldn't get a needle to it
• 40:58
  this this trial would not be for you
• 41:01
  but if there is um a place
• 41:03
  you know
• 41:04
  easy things are in the skin or in the lymph nodes
• 41:08
  but certainly in the liver is doable
• 41:10
  it just depends on where in the liver
• 41:13
  but if there are different spots that are injectable
• 41:16
  RPT2 is injected there is a backbone of Nivolumab
• 41:20
  so it is injection plus immunotherapy
• 41:24
  this trial is also in the first line
• 41:27
  so the whole idea is to say
• 41:29
  can this be the first thing that you go to
• 41:31
  when you have a new diagnosis
• 41:34
  they again so right now the trial is is pretty strict
• 41:40
  it doesn't allow any prior liver treatment
• 41:44
  that will change again
• 41:46
  we were talking about trials changing over time
• 41:49
  and that is um
• 41:52
  that is a trial that is it is due to change
• 41:54
  and that will allow some liver treatments
• 41:58
  but again
• 41:58
  local liver treatments not um Y90 not Delcath
• 42:03
  okay so super good to know
• 42:05
  and also to know that
• 42:06
  that trial specifically is gonna be changing
• 42:09
  and just you know
• 42:09
  as that pops up
• 42:10
  I guess I'll just go through the NCT number
• 42:12
  just to save you numbers but that NCT
• 42:15
  number will pop up at the bottom of the screen
• 42:17
  for this specific one the RP 2 + Nivolumab okay
• 42:20
  so I think that's that's a good recap of that one
• 42:23
  let's move on to our third one okay
• 42:25
  so now we're going to more um localized trials
• 42:30
  so the next trial is Tebentafusp with um Y90
• 42:35
  so Tebentafusp for Kimmtrak is already FDA approved
• 42:40
  a Y90 is one of those things that we use all the time
• 42:43
  that isn't specifically specifically used for uveal melanoma
• 42:47
  but this is just to test the combination
• 42:50
  because we usually use these therapies separately
• 42:53
  and we use them you know
• 42:55
  one then the other and maybe we can do Y90 again
• 42:59
  or something along that line
• 43:00
  but to do them together we don't
• 43:02
  really know whether that is a
• 43:05
  safe and B if it works better in combination
• 43:08
  so that trial is again
• 43:10
  an example of one of these trials
• 43:12
  that is only available at one center
• 43:14
  it's only available at the university of Miami
• 43:16
  so it is a trial that either you're local to it
• 43:20
  or willing to fly to it
• 43:22
  but that the two different treatments
• 43:24
  in and of themselves are available at other centers
• 43:27
  and the reason places will do a trial like this is
• 43:31
  you know we can put uh
• 43:35
  we can put each of these drugs together
• 43:38
  like we could do it at Stanford
• 43:40
  any of any center that does both of them can do it
• 43:43
  but when you do it on a trial
• 43:45
  then we actually can see you know
• 43:48
  not just a end of one or two of putting these together
• 43:52
  but doing you know
• 43:53
  an end of 20 or 30 where we really
• 43:56
  really understand if it's safe
• 43:57
  and if it works better in combination
• 43:59
  so these are the types of things that
• 44:02
  kind of seem like they're just easy to put together
• 44:05
  but to do it formally in a trial
• 44:07
  helps everyone understand how well this works
• 44:11
  and if it's safe okay
• 44:13
  well that's super good to know and um
• 44:15
  just I love that that we're bringing that up as well
• 44:17
  that like there's
• 44:18
  the reason behind it being at a single site versus like
• 44:21
  having many sites because
• 44:22
  you know I think that it
• 44:23
  it just helps right
• 44:24
  it helps if you're frustrated as a patient
• 44:26
  helps to know why something is the way that it is
• 44:29
  um and to know that it's not just out to
• 44:31
  like make your life more difficult
• 44:32
  there's a reason behind it
• 44:34
  um I have definitely heard that before
• 44:36
  and it's very easy to personalize
• 44:38
  yes no
• 44:39
  to personalize trial decisions
• 44:41
  and it really isn't a personal thing
• 44:43
  yes you're right
• 44:44
  okay so let's move on to No. 4 then
• 44:47
  thank you um
• 44:48
  so what's our next one on the list
• 44:50
  yeah so this is a um
• 44:51
  an interesting trial it's a brand new drug
• 44:54
  and a brand new mechanism in uveal melanoma
• 44:57
  so this is testing a drug called DYP 688
• 45:01
  so this drug
• 45:03
  the category is an antibody drug conjugate or an ADC
• 45:09
  there are other antibody drug conjugates that
• 45:13
  are available in in breast
• 45:15
  there's a couple that are available in breast cancer
• 45:17
  but we have not had an antibody drug conjugate
• 45:21
  tested in uveal melanoma
• 45:23
  and the way an antibody drug conjugate works is that
• 45:26
  it is um
• 45:28
  an antibody that that goes and finds a certain cell
• 45:32
  in this case this antibody is to something called email
• 45:36
  um but that is
• 45:39
  that antibody then hones hones in on a tumor cell
• 45:44
  and so um it
• 45:46
  it kind of makes a a beeline straight towards the
• 45:49
  the um
• 45:50
  tumor cell and and sort of docks there
• 45:53
  so that's the antibody part
• 45:55
  well the antibody is conjugated to a drug
• 45:58
  so it's attached to a drug
• 46:00
  so what happens is
• 46:01
  this antibody makes a beeline towards the
• 46:03
  the tumor cell and docks there
• 46:06
  but it carries a drug with it
• 46:08
  and in this case the drug random
• 46:12
  random name but SDZ 475
• 46:15
  but this is an inhibitor of the GP uh
• 46:21
  11 so
• 46:23
  you know the
• 46:23
  the common mutation that we see in um
• 46:27
  in uveal a melanoma and so what we
• 46:32
  what we are trying to do then is take the drug
• 46:36
  and usually these drugs are
• 46:37
  are a little bit more toxic
• 46:39
  so if you were to just give the drug as an IV or a pill
• 46:43
  it would be it would be pretty toxic to normal cells
• 46:47
  and just make people feel sick
• 46:49
  but what happens with an ADC is
• 46:50
  then you can take a more toxic drug
• 46:52
  and if it only then ends up in
• 46:54
  in where the tumor is
• 46:56
  it's toxic to the tumor and less toxic to the
• 46:58
  to the rest of the body is the idea of these ADCs
• 47:01
  and so this is um
• 47:02
  in a phase 1 trial
• 47:04
  it's only in a couple of sites in the US
• 47:07
  at Mass Gen in Boston and Columbia
• 47:11
  I think it's opening at Memorial Sloan Kettering also
• 47:14
  it's going to open in a in a larger cohort
• 47:18
  but mostly um
• 47:19
  internationally and not so much in the US but right now
• 47:23
  I believe it's in the Phase 1 setting
• 47:26
  still but this is something that is a brand new um
• 47:30
  mechanism so it'll be interesting to see if it works it
• 47:33
  it just like a lot of our drugs
• 47:35
  I mean it
• 47:36
  it sounds like a really good idea and then we'll see
• 47:39
  it's like oh
• 47:40
  this sounds great yeah
• 47:42
  but again
• 47:43
  this is a phase 1 trial and as we were saying before
• 47:46
  for phase 1 trials the idea is not to see if it's
• 47:51
  if this drug works or not
• 47:52
  it's really to see what dose is the best dose to use
• 47:58
  and the least
• 48:00
  the highest dose we can use without getting too toxic
• 48:03
  is really the point of a phase 1 trial
• 48:05
  and that's where this this drug is right now okay
• 48:08
  well that's also duly good to know right to and
• 48:11
  and maybe we could talk about that another time
• 48:13
  like kind of
• 48:13
  like the differences between the different phases and
• 48:15
  and why you might want to be
• 48:17
  you know entertaining a phase 1
• 48:19
  phase 2 or phase 3 trial and um
• 48:21
  and actually
• 48:22
  I think that we have done a little bit of some
• 48:24
  some discussions of that as well
• 48:25
  on the podcast in prior years
• 48:27
  so um
• 48:28
  but that's good to like understand that nuance okay
• 48:31
  so our fifth and final one that we have for the active
• 48:33
  recruiting list
• 48:34
  right now um
• 48:35
  is the next on my list um
• 48:37
  I'll let you go ahead and we can cover that one
• 48:40
  so this one isn't actually actively recruiting
• 48:42
  but it was really it was
• 48:43
  it was a recently
• 48:46
  um accruing trial
• 48:47
  so this was a phase 1 that was presented last year
• 48:51
  and I I wanted to
• 48:52
  to talk about it just because a
• 48:55
  there was a uveal melanoma um
• 48:58
  that that was treated on this trial
• 49:00
  somebody with uveal
• 49:01
  melanoma who had a really great response
• 49:03
  like a someone whose uveal
• 49:06
  melanoma had been pretty resistant to everything
• 49:08
  that we have so far
• 49:11
  and had a great response to this drug
• 49:14
  so um
• 49:15
  hey I just want to bring it out there
• 49:16
  because it's nice to know that these phase 1 trials do
• 49:21
  end up in some good results
• 49:23
  every now and then so even though
• 49:25
  so you may be in a situation where you're
• 49:27
  you're coming to your um
• 49:29
  oncologist and they say look you
• 49:30
  we've tried everything that's available
• 49:32
  these other trials um
• 49:35
  you're not a candidate for
• 49:36
  but we do have some phase 1 trials
• 49:39
  so phase 1 trials traditionally
• 49:40
  as you just heard um
• 49:42
  are really to talk about
• 49:44
  are really to determine toxicity levels
• 49:46
  and not to determine efficacy
• 49:49
  but they are an opportunity for hope
• 49:52
  if your body can take a phase 1 trial
• 49:56
  you know if you've been through a lot of drugs
• 49:57
  sometimes your body is not there right
• 50:00
  sometimes that is not um
• 50:01
  in the cards for you
• 50:03
  this is not the way to live the time that you have
• 50:08
  um but for some people who are just like
• 50:10
  I've tried everything and I
• 50:12
  I'm just as fit as the first day I started all of this
• 50:15
  and I'm really looking to do something
• 50:18
  um a phase 1 trial is something to consider
• 50:20
  and I you know I
• 50:21
  I wanted to bring up this drug
• 50:22
  so it's a prame um
• 50:24
  T C R T it's called I M A 203
• 50:27
  that was a phase 1 trial that closed last year
• 50:30
  and a patient with uveal
• 50:32
  melanoma who had a really fantastic response
• 50:34
  so you know
• 50:35
  phase 1 trials um
• 50:37
  not everybody's cup of tea
• 50:38
  uh you may be recommended for them
• 50:40
  you may be recommended not to do them
• 50:43
  but it is something to think about
• 50:44
  and every now and then
• 50:45
  you get something really good out of it
• 50:47
  so I just thought that I'd bring that
• 50:49
  that last trial up no
• 50:50
  I love that and I'm glad that you brought that up
• 50:52
  um I guess
• 50:53
  I just want to plug some of the noise that I've heard
• 50:55
  in connection with pharmaceutical companies
• 50:57
  so um
• 50:58
  just buzzwords to keep in mind as you're watching this
• 51:01
  next you know
• 51:02
  over the summer we've got ASCO coming up
• 51:04
  and these like
• 51:05
  oncology conferences
• 51:06
  are one of the best ways that our oncologists
• 51:08
  and the researchers who are in the space
• 51:10
  stay in the know as to like
• 51:12
  what's the current data for these trials
• 51:13
  but also are there new ones right
• 51:15
  are there new ones coming out
• 51:16
  sometimes they announce them shortly after these like
• 51:20
  clinical conventions like ASCO
• 51:22
  and so just some that I know of in the
• 51:24
  in the noise um
• 51:25
  Ionctura is one that you want to keep in the know
• 51:28
  we've announced that on social media
• 51:29
  and they are recruiting in Europe
• 51:31
  but they do have sites coming to the
• 51:33
  to the US they're just not open yet
• 51:35
  so just keeping that in mind
• 51:36
  um and then
• 51:37
  I know another one that we've talked about before
• 51:39
  on the podcast is actually TScan
• 51:41
  and they're working on continuing to open sites
• 51:43
  and just continuing to recruit for uveal melanoma
• 51:46
  um but it's
• 51:46
  you know there's
• 51:47
  there's some nuance to when and how often
• 51:49
  and which sites and so
• 51:50
  just kind of
• 51:51
  some of those ones are ones to keep in mind
• 51:53
  is there any other
• 51:54
  like potential companies you can think of that
• 51:56
  that people should watch out for
• 52:00
  no not
• 52:00
  not other than you had a great list there
• 52:04
  um but yeah
• 52:06
  that's that's what we've got so far
• 52:07
  yeah well
• 52:08
  and like you guys we talked about this before
• 52:10
  this changes right
• 52:12
  the number of trials like it may seem like okay
• 52:14
  like
• 52:15
  there's only four or five right now that are actively
• 52:16
  recruiting
• 52:17
  but there's also some that have some rapidly expanding
• 52:20
  sites there's some with really good efficacy
• 52:22
  so that means like the efficacy is
• 52:24
  and I don't think we covered this
• 52:25
  but efficacy means how well does it work
• 52:27
  um and so the data around some of these that are
• 52:30
  you know in the phase 3 trial or phase 2
• 52:32
  phase 3 some of the data is really
• 52:34
  really solid
• 52:35
  and that's really encouraging and really hopeful
• 52:37
  um so just know that these are out there and I
• 52:40
  I love that that you talked about just that
• 52:42
  that being an important aspect of this
• 52:44
  that patients have the hope right yeah
• 52:46
  yeah oh
• 52:47
  you know what um
• 52:49
  now that we're talking
• 52:50
  I just remembered there is a trial
• 52:52
  I don't have the NCT number at the moment
• 52:53
  that's okay we'll find it later
• 52:55
  but uh
• 52:57
  there is a trial
• 52:59
  um using cellular therapy
• 53:02
  so using TIL that is a one center trial
• 53:05
  that is at Memorial Sloan Kettering
• 53:07
  and that is you know
• 53:09
  for those of you who have not heard about TIL
• 53:12
  I mean it's a
• 53:12
  it's a very intense regimen but is
• 53:16
  has been showing some great results in um
• 53:20
  skin melanoma and was approved
• 53:22
  FDA approved earlier last year
• 53:24
  but TIL
• 53:28
  um TIL treatment is
• 53:30
  you have to have tumor that is resectable
• 53:32
  needs to be surgically resectable
• 53:34
  that surgically resected tumor um
• 53:37
  gets sent to a company
• 53:40
  which then filters out all of the t cells
• 53:44
  that are inside the tumor
• 53:45
  trying to attack the tumor
• 53:47
  so those are your own immune cells
• 53:49
  that now have recognized this is
• 53:52
  this is bad news and um
• 53:54
  and knows how to sort of infiltrate into
• 53:57
  into the headquarters and so they take up these t cells
• 54:00
  you can think of them as you know
• 54:02
  like Navy Seals and they clone them
• 54:05
  so they clone them to the billions
• 54:06
  multiple billions and then um
• 54:10
  when they are cloned
• 54:13
  they are so usually takes about 5 weeks or so
• 54:15
  they are sent back to your site and um
• 54:19
  then a patient undergoes what's called lympho
• 54:21
  depleting chemotherapy so
• 54:23
  that means
• 54:23
  chemotherapy that knocks out your bone marrow
• 54:26
  cause you need to have enough space for these billions
• 54:29
  of t cells to
• 54:31
  to live and grow so you get pretty intense chemotherapy
• 54:37
  it's bone marrow transplant type of chemotherapy
• 54:41
  so you know
• 54:42
  you're losing your you're nauseous tired
• 54:45
  losing your hair like all of
• 54:46
  all of the things
• 54:47
  and then you get the t cells infused back in your body
• 54:53
  and in order to wake up the t cells
• 54:55
  you get a drug called IL2
• 54:58
  IL2 is um
• 55:00
  what makes people who are sick and dying in the ICU
• 55:04
  feel like they're sick and dying
• 55:05
  it's a it's like an 5 alarm
• 55:09
  um 5 alarm system to your body saying wake up
• 55:13
  every immune cell that's in your body
• 55:15
  wake up and it really makes people feel sick
• 55:18
  and it actually can drop your blood pressure
• 55:20
  to a point where it can be dangerous
• 55:23
  the chemotherapy that has knocked out your bone marrow
• 55:27
  your cell counts can get down to very low
• 55:30
  and that can be dangerous
• 55:32
  so you can
• 55:33
  there is a treatment related death with this therapy
• 55:36
  that is about seven and a half percent
• 55:38
  it's it's not nothing
• 55:41
  but at least in um
• 55:44
  skin melanoma
• 55:44
  we've seen people who have gone through everything
• 55:47
  under the sun and their melanoma is still growing
• 55:50
  um this therapy can work
• 55:52
  but it's very intense there's usually an age limit
• 55:55
  you definitely have to be very fit in order to go
• 55:58
  undergo this but that is another um
• 56:01
  one institution trial and hopefully that'll get bigger
• 56:05
  but at the moment um
• 56:07
  this is a pretty complex regimen
• 56:09
  as you can imagine um
• 56:10
  between the surgery and the chemo and
• 56:12
  you know flying your tumor out to a
• 56:15
  to a company and all of that stuff
• 56:17
  so well and that is what limits that trial
• 56:19
  I don't I don't know if you know of this patient
• 56:21
  but I know of at least one patient who was on
• 56:23
  kind of the earlier TIL trial
• 56:24
  um and she had uveal melanoma
• 56:27
  and she's one of the rare people who had
• 56:28
  I think they're calling it a complete response
• 56:30
  I think she's more than 5 years out from metastatic
• 56:33
  um she has a very
• 56:34
  you know a very intriguing story
• 56:36
  I'm really hoping to get Katie Doble on the podcast soon
• 56:38
  um but cool
• 56:39
  she is someone that you can look up
• 56:41
  some information about on social media
• 56:42
  she's all over um
• 56:44
  on some different news articles things
• 56:45
  like that uh
• 56:46
  so there is some you know
• 56:47
  there is some reason to consider
• 56:48
  but I love that you um
• 56:50
  just outline some of the good things to be aware of
• 56:52
  as well like just in considering that as an option
• 56:55
  well Doctor Funchain
• 56:55
  I so appreciate you
• 56:58
  and I feel like we've had such a dense discussion
• 57:00
  so you guys like
• 57:00
  please save this come back to it
• 57:03
  listen to it again if you need to send it to
• 57:05
  you know
• 57:05
  somebody else to absorb the information on your behalf
• 57:07
  if needed but Doctor Funchain
• 57:09
  thank you so much for your time
• 57:10
  and for just providing this space of
• 57:12
  you know I feel like empowering information
• 57:14
  but also just I I feel like
• 57:16
  a good message of hope to patients
• 57:17
  with ocular melanoma
• 57:19
  thank you I
• 57:20
  I always love talking about these things because it's
• 57:23
  um
• 57:25
  it's good to know there are options out there um
• 57:27
  and it's good to know all of the different
• 57:30
  you know it's
• 57:31
  it's not just like
• 57:32
  buying a ticket or buying a candy bar right
• 57:35
  there's a lot of considerations in
• 57:36
  in thinking about trials
• 57:38
  and we're always happy to provide information
• 57:41
  but it's also different to hear about it from people
• 57:43
  like you and to
• 57:45
  to talk about the
• 57:46
  the pros and cons and all of those things
• 57:47
  so thank thank you for having this um
• 57:50
  this place that we can have these conversations
• 57:54
  and talk about the all the details
• 57:55
  the the good
• 57:56
  the bad the ugly um
• 57:57
  but most importantly the hopeful
• 58:01
  well I really appreciate you
• 58:02
  and all of the other doctors we have in this space
• 58:04
  who are doing the work
• 58:05
  and just bringing trials to patients
• 58:07
  and doing the best that they can to
• 58:09
  make this an accessible space both
• 58:11
  you know through information
• 58:12
  but also through location and all of those things
• 58:15
  and just another huge shout out to our sponsors
• 58:17
  who make this podcast and our YouTube channel
• 58:20
  your go to resource for ocular melanoma information
• 58:24
  and just the kind of the latest news
• 58:26
  we could not do this without our sponsors
• 58:27
  so thank you again to our sponsors and
• 58:30
  and again
• 58:30
  just final thanks to our guest Doctor Funchain
• 58:33
  we will see you guys next time