Clinical Trials.gov Post of Expanded access of PD1

[Catherine Poole]

Here it is! http://clinicaltrials.gov/ct2/results?term=+NCT02083484&Search=Search

The idea behind an EAP is that it is to meet an unmet need, therefore you must have failed IPI, a different PD1 or braf agents to get this access.

[rochelle]

Catherine,

What great news!! Just to know this is in the pipeline is so encouraging to so many. I was under the impression that Anti pd 1 was on such a fast track that there would not be enough time to launch the EAP programs ahead of it…no matter…it’s here..may all those who need it…get it.

Thanks for the info,

Martha

[PatW]

I’m confused. The ClinicalTrials.gov write-up says: “Exclusions: Eligible for treatment with a marketed BRAF/MEK inhibitor.”

Does that mean that if you have the BRAF mutation (and your physician agrees), you must have tried and failed BRAF monotherapy or tried and failed MEK monotherapy? Or does it mean that, if you have the BRAF mutation (and your physician agrees) you must have tried and failed the BRAF+MEK combo? Why the slash between BRAF and MEK? Why not a simple “and” “or”?

[Violeta]

Very grateful for this info, Catherine! I will follow carefully your posts, I am hoping they will extend the program also in Europe ! Thanks a lot!

[Catherine Poole]

Violeta, I hope too that it is in Europe soon, the need is great there too. I will definitely keep you posted. PatW, my understanding is that if you are BRAF positive, you must have tried one of the BRAF therapies and progressed, so that would be inclusive of the Braf/mek.

[PatW]

Thanks, Catherine. Since MEK is not a BRAF inhibitor, one must have taken (and presumably failed) either Zelboraf or Tafinlar (with or without Mekinist). So patients who have taken either BRAF inhibitor as monotherapy do not have to go back and try BRAF+MEK before being eligible for the anti-PD1 EAP. That was my concern. Thank you for clarifying that.

[njreaders]

why would Merck exclude patients with active central nervous metastases from early access to this drug?

[lak1]

Catherine,

can Eu patients travel to US for this?

[Author]

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