Accessing Pembrolizumab as a First License Treatment
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I am trying to help a friend who is a mother to two small children research her options as quickly and accurately as possible. She has a very aggressive melanoma that was only diagnosed several months ago. She had a grapefruit sized tumor removed with lymphnodes (2 of 33 were infected) in November but it has grown back aggressively in local areas (back, shoulder arm). Her last scan 4 weeks ago showed no growth to other organs and she was told it was stage IV and metastic.
She now seems to be with one of the best doctors in the field in London’s NHS, who has put her on Vemurafenib, as he felt Ipilimumab would take too long for her to start working. The Vemurafenib has drastically shrunk the tumors, but she’s been told this has a 50% drop off at 7-9 months. Pembrolizumab seems to be the most effective treatment at the moment but currently in the UK it is only licensed as a second license drug after using Ipilimumab so she is not elegible.
She has been told that Pembrolizumab will be upgraded to first license in the UK at some point this year. From my recent research and from what she has been told, her greatest hope lies in accessing Pembrolizumab. So we are trying to research ways of accessing it if her Vemurafenib medication stops working before Pembrolizumab gets first licensing in the UK.
It seems that the USA is ahead of Europe which is ahead of Australia in the licensing of these particular drugs. When is Pembrolizumab due to have first licensing in the US? Is it possible to pay for private treatment in the US as a stop gap until it’s licensed in the UK? Does anyone have any leads as to how you would proceed with this, or set it up so treatment can be accessed immediately if needed?
My friend’s family mirrors mine to a great extent so I have huge empathy for her situation. She has a lot of information to absorb in a very short period of time and her husband is under immense stress with all the practical burdens that a diagnosis like this brings, so she is finding my research efforts helpful. I’m sure she will join this forum herself, but in the mean time if I can arm her with any additional information or useful questions to present to her doctor at their next meeting I would be most grateful.
Thank you in advance
Sonia
Dear Sonia, I am very sorry to hear about your friend’s situation. I am also a friend of a melanoma patient.
I think that you have done good research on possible therapies and I also want to say that you are doing an amazing thing for your friend.
Regarding treatment, there are few options to get anti PD1 (Pembrolizumab or Nivolumab) as first line therapy in Europe. You can search here for clinical trials:
https://clinicaltrials.gov/ct2/search/advanced https://www.clinicaltrialsregister.eu/ctr-search/search The first website is global, the second is for Europe and most of the trials in Europe can be found in both databases. To be honest, I have not figured out exactly what trials are in the either or both databases. The advantage of the first is that it shows if the trial is recruiting or not yet open.
I understand the stress to find a new therapy before the Vemurafenib stops working. You can look up “intermittent dosing”, which is an attempt to avoid resistance by making breaks or using a lower dosage. You can also look up the combination of BRAF+MEK inhibitor.
My personal idea – but please remember that I am not a doctor – would be that if she can’t access anti PD1 now, go for Ipilimumab (brand name Yervoy) while the tumor burden is low and while the BRAF inhibitor still works. If Ipi does not work, go for anti PD1 if you can or go back to the BRAF inhibitor to shrink the tumors and then go for anti PD1. I’m saying this because I am afraid that when resistance develops there is a risk that the melanoma will be very aggressive and you don’t know how long it will be until then.
There is a trial for Nivolumab that is open in the UK (prior Ipi is required):
https://clinicaltrials.gov/ct2/show/study/NCT02156804 All the best to you and your friend.
Your friend may do better on the BRAF/Mek combination by Glaxo and approved in UK. I would check with Cambridge for access as well as the Marsden. First line is not available in the US yet, sadly. So it may take some time for that. I am working on an update from Pharma today for global locations and will post asap. It does look like IPI pretreatment is required for most PD1 therapy locations. I just found the Checkmate trial as having several locations recruiting globally. This is the PD1 and IPI combination trial, NCT02156804. Go to for locations: https://clinicaltrials.gov/ct2/show/NCT02156804 Thank you Eva and Catherine for replying so quickly. I had found a few similar clinical trials but none that were recruiting in the UK so thank you so much for putting me onto this. I do not have enough of her patient information at this stage to know if she will be eligible but at least now she can discuss it with her doctor and take it from there.
With kind regards
Sonia
Excuse me Catherine, you seem to know an awful lot! I’ve emailed the Clinic Trials that you led me to to get a contact for the UK site that is currently recruiting. They haven’t replied. Do you know any other way to get their number?
https://clinicaltrials.gov/ct2/show/study/NCT02156804?show_locs=Y#locn At:
Local Institution Recruiting
Wirral, Merseyside, United Kingdom, L63 4JY
Contact: Site 0062
Thank you in advance
Sonia
This is the site: http://www.clatterbridgecc.nhs.uk/patients/doctors.aspx and this is the melanoma doctor listed. I will try to find out more.
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