Amplimmune Trial

[seasidemama]

Hi,

I am new to this forum and would love to know if anyone is currently enrolled in the Amplimmune Anti PD 1 trial?

Thanks,

Laura

Daughter of a Stage IV fighter aka best dad in the world!

[seasidemama]

Here is what I found out this week about the Amplimmune clinical trial-

(Summarized from Amplimmune site)

Amplimmune is a fusion protein that blocks the interaction between PD1 and B7-H1, allowing Amplimmune to overcome immune suppression allowing the immune system to fight successfully against cancer and chronic infections.

Trial Meds

-Low dose cytoxin (chemo) given on day 0(day before antibody given) this allows the T-cells not to react so much

-day 1 the Amp 224 is given by infusion, day 15 Amp 224 given

One trial site is seeing minimal side effects and infusion related reactions.

I hope this might help us all navigate some options.

Laura

Daughter of a Stage IV fighter aka Best Dad in the World!

[Catherine Poole]

Yes, this is what I posted this week as having some openings. It is a phase 1 trial, so they are just looking at dosage. Not much else known about this PD1 yet.

[NYKaren]

I was told that the CURRENT Amplimmune trial is for BRAF+ patients only. Does anyone know about that?

karen

[seasidemama]

For the openings at Sarah Cannon, you do not have to be BRAF positive.

[NYKaren]

Thanks, I didn’t think so. The info link doesnt list Sloan Kettering as a site, but they do have one at Sloan for Braf+ people. I might have been given the wrong info, I will check it out when I go on the 30th.

[seasidemama]

Karen,

It looks like there will be a second part to the Phase 1 of the trial for “a certain tumor type”

It does not say what type though, maybe BRAF.

Laura

[Catherine Poole]

please look here for restrictions etc: http://clinicaltrials.gov/ct2/show/NCT01352884?term=nct+01352884&rank=1

Must have failed Braf therapy is what I understand.

[bettin]

This is a PHASE 1 first-in-human trial- so there is nothing known about how this drugs performs in humans (with the exception of some early Phase 0/ preliminary studies they might have done). PD1 generally seems to be a good target in general but the question is whether Amplimmune actually hits its target, so there is a high degree of uncertainty.

In this light, I actually believe that the inclusion criteria (•’Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors’) is ethically the right thing to do- you should exploit all therapy options KNOWN to work before subjecting patients to treatments that only MIGHT work.

Bettina

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