Expanded Access Program With Nivolumab for Subjects

[LynnLuc]

Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti_CTLA-4 Monoclonal Antibody https://clinicaltrials.gov/ct2/show/NCT02142218

[Catherine Poole]

I’m getting the details on this shortly and will post here.

[Catherine Poole]

So this will require, like the Merck program, that you first must fail IPI and BRAF drugs is you are positive. It does not allow prior PD1 of any kind. It is rolling out with a conservative estimate of 14 days. Locations will likely be those that had prior trials. Stay tuned for more on global locations.

[njreaders]

Glad to see that this program is moving along but once again like the Merck 3475 early access it penalizes folks who have active brain mets and who are suffering physically because of them.

peggy

[Steven]

Is it possible that the final FDA approval will also have the requirement about previous ipi use? Are there any other drugs in the world that require previous use of another drug?

[Catherine Poole]

Good question, but not what I have heard. The requirement will be for stage IV disease though. These requirements are based on clinical trials that they follow up and to meet unmet need, i.e. you must try the FDA approved drugs and run out of options.

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