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Trial Toxicity

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Trial Toxicity

Posted By
4/6/2020 2:27pm
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Replies: 9

Reaching out to those that were on the original Ipi/Nivo trials....
Had a call today that bloods show increase in Liver enzymes to Grade 1 for one enzyme and Grade 2 for the other. Have to go back tomorrow for more bloods. For those on the original trials did you get to go back into the trial if you had to pause treatment for toxicity?
At the moment I think I can carry on but if it rips into Grade 3 I guess that will be it. Feedback appreciated

ed williams - (4/6/2020 - 5:44pm)

Hi Mark, here is a link to uptodate on standards for oncologists to follow in the US. Authors are big names in the melanoma world. Dr.Postow and Dr. Wolchok and Dr. Atkins are listed. I know standards can vary from country to country and trial to trial so your oncologist would be your best source of information. I was on checkmate 067 but didn't develop an IRAE (grade 3 colitis) for 5 years and 9 months into treatment, so kind of odd to develop so late, and at that point I was kicked off the trial officially. I was in the nivo monotherapy arm of the trial not the combination. Here is the link!!!

MarkR - (4/6/2020 - 6:36pm)

Thanks Ed very helpful if not a little concerning!!

Bubbles - (4/6/2020 - 8:36pm)

Hey Mark,

There is a lot of variation between trials - not sure that is a good thing, but seems to be the case. Back in 2010 in my Nivolumab phase 1 trial, the first set of paperwork was over 20 typed pages (there were many multipage updates that required additional signature over the next years for continued participation) and while some of it was pretty confusing, reasons for removal from the trial were laid out fairly well. So you might look back on any papers you signed for possible clarification. Ultimately, however, whether looking at progression (which definitely got you kicked off my trial) or lab values that help categorize adverse reactions - where to draw the line is somewhat subjective. Therefore, a heart to heart regarding how your doc looks at these things is probably your best source of clarification on what will be tolerated and allow for continued participation.

Hang in there. Hope that your lab values improve quickly!!! yours, celeste

MarkR - (4/7/2020 - 4:21am)

Thanks Bubbles - have an appointment with them this afternoon and more bloods this morning so will see what the plan is - hoping I can persuade them to keep me going for now

Hope you are all keeping well over there in the current situation

Mark_DC - (4/6/2020 - 11:44pm)

Hi Mark,

I dont have much to offer you but wanted to write once I saw you posting!
I was on a clinical trial a few years back testing ipi vs pembro - I think i hit a grade 3 or close to it and the rules were that i was taken off.
I progressed so later they put me on pembro neo adjuvant rather than surgery ( surgery had led to recurrence so they opted against) — After three months treatment i came close to a grade 3, was taken off, put on prednisone, liver numbers came down, rechallenged and the liver numbers for some reason stayed fine

To keep my liver numbers down they told me no alcohol and no paracetamol. Honestly i dont think this made any diffeence as i take ibuprofen not paracetamol and didnt drink very often. Still it meant a year of going teetoal.

So my advice would be maybe no alcohol and no paracetamol might help you
If the numbers go up can you go on steroids to fix then restart
Can you pause now to get the liver numbers OK and then go back on treatment

Good luck Mark, these are grim times for all of us and even more so for the British
Best wishes Mark

MarkR - (4/7/2020 - 4:19am)

Thanks Mark - I think it will be holding treatment for now but I am close to Grade 3 on one set of results so if it rises much more I may have an issue. I had been drinking a bit but no more than 2 beers in any day but stopped as of last night.

Biggest worry is that with the UK situation all new trials are suspended and they are unlikely to even give me Chemo due to the virus. We have been in countrywide lockdown for 2 weeks now and it’s almost certainly going to go on for another month so hard to see how this ends well. The real frustration is I am confident I have had no progression since the last infusion so it seems to be working
Hope ur keeping ok over there as it looks like it’s been getting much worse over the last few days

Mark_DC - (4/7/2020 - 11:05pm)

Hi Mark - we have various degrees of lockdown here and my last appointment was cancelled although I got my scans in just in time (Friday the 13th) and the results were reasonably good. I do fear that the Covid crisis is hurting other patients who are now denied treatment. Creates additional stress particularly for those just about to start treatment or who need surgery.

I hope your numbers come down either by taking a pause or by taking prednisone if the trial allows this (but doing this might be risky now because of the virus so could be a bad idea). I hope the trial is working and that you can just pause.

News all around the world is terrible and I follow the UK closely. They may make royal marsden deal only with cancer cases because other hospitals too stressed with Covid 19. Good luck Mark


MarkR - (4/8/2020 - 3:53am)

It’s a tough time - in the UK I know people who’s surgery and / or treatment has been cancelled with no idea given on when this may occur. The press is raising concerns that by denying these people treatment they are going to be killing them later down the line. It’s why I have been so concerned about being bumped from the trial as they are no trials recruiting and no one allowed to start chemo.

Fortunately yesterday’s results were stable for liver enzymes so having a 2 week treatment break with some steroids to bring the levels back down. Hopefully carry on again in a couple of weeks

Glad to hear you are doing ok as well. Stay safe out there

MelMel - (4/11/2020 - 7:15am)

Glad to hear your liver enzymes are on the mend. I just wanted to share that I had the same thing happen to me although I was not on a trial. Just for your information, AST decreases more rapidly than ALT.
Best of luck and stay safe.