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Keynote 716 - trial for stage 2B/2C

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Keynote 716 - trial for stage 2B/2C

Posted By
Lrazski
6/28/2020 12:16pm
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Replies: 6

Hello all,

This is my first post here, however in the past few weeks I have visited quite frequently to learn from all of your helpful posts and comments!
I am currently considering participating in the Keynote 716 trial, which is testing the effectiveness of treating stage 2B/2C patients with Pembrolizumab(Keytruda) adjuvant therapy. I haven’t seen much on here about this trial so I wanted to see if there are others out there considering this for their “high risk” stage 2 melanoma. Some background on me is below. I also would love any input from those of you who have been treated with Pembrolizumab in terms of side effects and things like that. I welcome any of your opinions! Thank you :-)

About a month ago I was diagnosed with superficial spreading Melanoma on my back, biopsy revealed it was Breslow thickness of 3.2mm with ulceration, making it stage 2B. WLE had clear margins and SLNB came back negative, confirming the stage 2B diagnosis. I also had the decisiondx castle testing done which classified it as class 2B, the highest risk of recurrence (50% chance of recurrence within 5 years). I am 26 years old so I am also trying to weigh the infertility risks of the adjuvant treatment since there is not much data on those risks yet.

More about the trial.. 50% of patients will receive Pembrolizumab and 50% will receive a placebo. It is a double blind study so neither doctor nor patient will know if they are receiving the drug or placebo. Treatment will be about every 3 weeks for a year.

Hi Lrazski,

Sorry you have the need to be here, but welcome. Many many many patients on this forum have been treated with anti-PD-1 of which there are two products: Pembrolizumab (Keytruda) and Nivolizumab (Opdivo). For all intents and purposes, they have thus far proven to have the same response rates and side effect profiles in Stage III and Stage IV patients. Your trial is new in that it is looking to expand the group for whom adjuvant therapy can be used. As a rattie in an adjuvant phase 1 trial of nivo for Stage IV patients from 2010 to 2013 - CHEERS!!! Ratties rock! And, thank you!
Side effects vary a great deal person to person, however here is a report I created for nivo that still applies to it and pembro as well as far as the most common side effects and why we get them:
https://chaoticallypreciselifeloveandmelanoma.blogspot.com/2013/10/side-...

Here is a post that I put together for patients embarking on adjuvant therapy that may interest you: https://chaoticallypreciselifeloveandmelanoma.blogspot.com/2020/03/adjuv...

Hope this helps. I'm sure others will chime in as well. I wish you my best. Celeste

Dear Lrazski,

I went from stage 2 to stage 3 pretty quickly, so would have liked this option if it had been available to me.
There are pros and cons from going ahead - if you dont go ahead you can save the pembro until later and you can avoid unnecessary side effects.
However, most of us want to have the sense that we are doing something, so I would go for it. Aside from helping future patients by taking part in the study, another good argument for taking the trial is that this ensures that you will be monitored closely as well, so that if anything pops up they should catch it quickly. I was kicked out of my trial long ago (side effects) but the trial patients i think got better treatment than the regulars and I felt i was contributing.
But it has to be your personal choice!
Good luck
Mark

as a 3c patient I have been on 240mg Nivo(opvido) twice a month for the last 6 months. absolutely no side effects. 4 lymph nodes identified as melanotic and removed 6 months ago. . NED as of last week.

it is time consuming and you will need a operation to install a port. No minor thing. You may not be able to get an elective surgery scheduled depending on your state. Even excision of a non-melanotic mole by my Derm was prohibited in my state until a month ago and now looks like that elective surgery prohibition is about to be re-instated.

as a result of immunotherapy my Onc tells me in no uncertain terms i am High risk and exposure to Covid will have serious consequences for me. I am unsure but don't think a NED melanoma carries any covid risk.

in short inform your choice in light of Covid.

I imagine port is probably optional. Definitely better if you're on the 2 week cycle. I do monthly cycle of opdivo and wasn't even asked about a port.

I was diagnosed 2B about 7 years ago and am now IV and I would have leaptt at the chance then and retroactively now.

Hello all!

Thank you for your responses. I wanted to give an update! After discussing with my oncologist, I was referred to VCU to discuss the trial with the study doctor, Dr Poklepovic (who is wonderful by the way!) I decided to participate in the trial and am doing all the pre-trial scans and labs this week and will probably start the first treatment the first week of August. The trial is closing for enrollment this week so I am grateful to have been fit in before it closed!

I look forward to sharing my experience with you. Thanks again for the welcome and responses!