PD1 trial for patients with brain mets trial recruiting

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PD1 trial for patients with brain mets trial recruiting

Postby Catherine Poole » Sun Apr 20, 2014 7:12 am

A patient just informed me of this trial actively recruiting: http://clinicaltrials.gov/ct2/results?t ... rch=Search
It is at Yale only it looks. the link has contact info for Harriet Kluger, MD the principal investigator.
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: PD1 trial for patients with brain mets trial recruiting

Postby jeffb » Sun Apr 20, 2014 9:05 am

This is great news Catherine and thanks for posting it.

Yeah, the trial size is relatively small and at one location, but Merk and Yale are thinking about it and I suspect there may be some data which warranted further investigation . Good news.

No exclusions for any number of prior systemic treatments but they need to have been completed at least 2 weeks earlier. This is good but, what caught my attention, was that there were no specific exclusions prior IPI or Braf/Mek. This could be very important indeed.

Also, also, you can have up to 10 mg of predisone equivalent per day.

This is good Easter news. Thanks Catherine.
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Re: PD1 trial for patients with brain mets trial recruiting

Postby MilaR » Mon Apr 21, 2014 3:22 am

I spoke with them a couple of weeks ago. They have more exclusions than the site shows. E.g. they told me:
The MK-3475 brain metastases trial requires at least 2 untreated brain metastases to be present. 
The trial requires one of the brain metastases to be surgically resected or biopsied.  If the patient has had a previous brain metastases biopsy and there is archival tissue available we can use this.
 
The trial requires the additional brain metastases to be within 5-20mm,  This is considered the ‘target’ lesion used to measure response to treatment with MK-3475.
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Re: PD1 trial for patients with brain mets trial recruiting

Postby njreaders » Tue Apr 29, 2014 11:12 am

What do you mean that the size of 5 to 20 mm is the size to see if the Merck 3475 is working?
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Re: PD1 trial for patients with brain mets trial recruiting

Postby jeffb » Tue Apr 29, 2014 6:26 pm

Yes, it's a measurable size that they can use to get accurate measurements. The lower limit is set by the resolution capability of MRI and I imagine the upper limit set for safety. The "target" mets must also be in an area of the brain that is judged to be tolerant of any growth that may occurr during treatment. Other mets can be zapped with radiation or surgically removed.

Jeff
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Re: PD1 trial for patients with brain mets trial recruiting

Postby njreaders » Tue Apr 29, 2014 7:00 pm

thanks
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