BMS PD1 Trial possibly recruiting

[Catherine Poole]

This trial doesn’t have any IPI restriction and is a phase 1 (dosage) not sure how many openings, but call the centers to check for sure: http://clinicaltrials.gov/ct2/show/NCT01714739?term=kir+pd-1&rank=1

[lindamg]

I found that trial is not recruiting anymore at the University of Chicago. I don’t know about the other places. I asked the contact at the University of Chicago about another trial: Anti-LAG with Nivolumab (Nivolumab given in 2 of 3 arms) NCT01968109, and he said that trial will begin recruiting in mid-February. Interestingly (and frustratingly) prior ipi is an exclusion even though it is not used in the trial. There is an exclusion reference to “Any prior exposure to immune cell modulating antibody regimens except as described…” which I guess covers ipi; however, prior anti-PD-1 and anti-PDL are allowed in two of the parts of the trial if the patient was unresponsive and progressed on those treatments. Interpretation is difficult but probably some response followed by progression would not be allowed.

[lak1]

No ipilimumab is allowed

“Exclusion Criteria:

Prior therapy with an immune cell modulating antibody except for anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA4)

Active or chronic autoimmune diseases

Uncontrolled or significant cardiovascular disease

Chronic hepatitis

Active infection

Active Central nervous system (CNS) metastases”

Ipilimumab is anti cytotoxic T lymphocyte antigend 4(CTLA4) so that is excluded from the exclusions

[Catherine Poole]

I’m reading this as: Prior therapy with an immune cell modulating antibody except for anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA4)

The exception being IPI, so it does allow IPI. I know the writing is terribly confusing in these trials.

[EricW1]

I have been in contact with a trial coordinator for this and ipi is allowed….

[NYKaren]

It also says “No prior treatment for 8 weeks.” I’m on the BRAF/MEK combo–after 8 weeks my brain mets are bound to come back! I’ve had gamma knife on 14 and 17 mets. Not fun. This is so frustrating! I just had a clear MRI, but last night noticed a new flat black met on my scalp. Ugggg!

I’m just scared! If the combo fails me, I’ve tried everything else: Ipi twice, radiation, chemo, IL2, Zel…sorry to hijack your post.

Karen

[Catherine Poole]

You might try the ADC trial, Jonathan has posted extensively about it.

[NYKaren]

That’s a great idea to check out. I kinda forgot about it today. Thanks & Happy New Year, Catherine.

Karen

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