MEDI4736

This topic contains 69 replies, has 19 voices, and was last updated by  mickh 1 month, 2 weeks ago.

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July 2, 2014 at 8:04 am  #1264728    

Bill

Mike – can I ask who your oncologist is? Thanks, Bill

July 2, 2014 at 8:10 am  #1264729    

Bill

Janine – I have not getten into a trail yet….still working on it! I’m was close with the IPI/NIVO trail at MSKCC, but I had an infusion of Docetaxel, and the scan showed that the nodes shrunk, so that put me out of contention. You ned to be “unresponsive” to any chemo to qualify. I missed out on the MEDI4736 at Sloan because I was tested negative by Medimmune for PD-L1, but I question that result. Bill

July 2, 2014 at 8:14 am  #1264730    

mrkenney

I don’t know who tested the biopsy sample.
My oncologist is Dr. Michael J. Pishvaian @ Georgetown University Hospital

The gentleman in charge of the study I’m on is Dr. Ion Cotarla

July 2, 2014 at 8:16 am  #1264731    
catdander forum moderator
catdander forum moderator

I’m sure you have this info but just in case, For more information about this study and to inquire about eligibility, please contact the office of Dr. Neil H. Segal at 646-888-4187.

I’m sorry you’re having difficulty with testing. I’ve heard chatter about fresh biopsies but nothing specific or conclusive. I’d think if there isn’t a standard of testing then each trial selects the test to be used for continuity. Too I noted in the trial inclusion criteria listed on http://clinicaltrials.gov/ct2/show/NCT01693562 , “Available archived tumor tissue sample” and “Willingness to provide consent for biopsy samples (dose-expansion only)” was needed. curious.

I’ll ask Dr. Pennell to respond also. He has been active in molecular testing and may have input here.

All best,
Janine


My husband, 8/09 53 @ dx stage III squam nsclc R. pancoast tumor
Destruction of 3 ribs, touching brachial plexus.
6/09-8/09 2 core and 1 VATS undx biopsies. Open thoracotomy for 1 positive biopsy (unresectable)
9/09 Chemo/rads curative intent
11/09 MRI by pancoast specialist surgeon spine met found undiagnosed Rad to spine, Chemo continued thru 6 cycles
Tarceva maintenance 2/10
11/10 3cm tumor L lung, undx core bx w/collapsed lung. Gemzar, 12/10 through 7/12
NED 3/12, stop tx 7/12. Remains NED as of 9/16
Unanswerable question. Was it ever metastatic?

July 2, 2014 at 9:28 am  #1264732    
Dr Pennell
Dr Pennell

Hi Bill, I know that the issue of PD-L1 testing and what the results mean can be confusing. PD-L1 is a protein on tumor cells and tumor stroma (the normal non-cancerous tissue in a tumor) that binds to PD-1 on immune cells and causes the immune system to turn off, allowing the tumor to escape destruction by the immune system. The drugs targeting PD-1 and PD-L1 interfere with this process. The idea behind looking for the presence of PD-L1 in the tumor is that blocking this system seems to be more effective when the PD-L1 is there. Perhaps if it isn’t there then the PD-1/PD-L1 system is not preventing immune attack and giving the drugs won’t do anything.

There are several issues with this assumption. First of all, every company uses a different method to define “PD-L1 positive”, using different antibodies and different cutoffs of what is positive or negative. So theoretically a biopsy could be called “PD-L1 negative” by one test and be called “positive” by another. Second, PD-L1 expression can vary from area to area within a tumor or even in different sites of spread within the body, so any one biopsy may not reflect the whole cancer; i.e. they just may have missed the part that was positive and biopsied a negative area. Finally, PD-L1 expression may change over time and with treatment. If the tissue being tested is from the time of diagnosis and is negative, it is possible that later on after radiation or chemo that a new biopsy could be positive. All of these are hypothetical but this illustrates how little we really know about this biomarker.

We do know that some patients labelled “PD-L1 negative” still do respond to immune checkpoint inhibitors, and my guess when that happens it is for one of the above reasons. Since most trials require PD-L1 to be positive, then the options would be to be tested again using another test (or with another biopsy), or to enter a trial that does not require a positive test.


Nathan Pennell, MD
Associate Professor, Solid Tumor Oncology
Cleveland Clinic Taussig Cancer Center

Views expressed here represent my opinion, not those of GRACE or Cleveland Clinic Taussig Cancer Center. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

July 2, 2014 at 10:19 am  #1264734    

Bill

Dear Dr. Pennell,

Thank you so much for so perfectly articulating the issues with the PD-L1 testing as we know them at this point in time.

Should I have requested to Dr. Neil Segal at MSKCC to do more testing on new tissue before I let them toss me from the trial? After reading your assessment, I wish I had.
Bill

July 2, 2014 at 10:27 am  #1264735    
Dr Pennell
Dr Pennell

Well, it depends. If the test was on an old biopsy then a new one is reasonable to consider but certainly not trivial and depends on how safe it is and whether the cost would be covered by the study. If the test was on a recent biopsy then I am not sure how likely a running of the same test would be to show something different.


Nathan Pennell, MD
Associate Professor, Solid Tumor Oncology
Cleveland Clinic Taussig Cancer Center

Views expressed here represent my opinion, not those of GRACE or Cleveland Clinic Taussig Cancer Center. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

July 2, 2014 at 1:19 pm  #1264742    

Bill

Mike – the study is at Georgetown U Hospital?

July 3, 2014 at 6:13 pm  #1264770    

Bill

Hi Mike,

I found info on Dr. Michael J. Pishvaian @ Georgetown University Hospital…thanks.

But I can’t find any info on your trial and/or Dr. Ion Cotarla on the GUH web site? Thoughts?

Bill

July 4, 2014 at 8:42 am  #1264779    

cards7up

This is the only clinical trial I could find with a location in Washington, DC. This might be the one he’s on.
Take care, Judy
http://clinicaltrials.gov/ct2/show/NCT01693562?term=MEDI4736+and+NSCLC&rank=8


Stage IIIA adeno, dx 7/2010. SRS then chemo carbo/alimta 4x. NED as of 10/2011.
Local recurrence, surgery to remove LRL 8/29/13. 5.2cm involved pleura. Chemo carbo/alimta x3. NED

July 4, 2014 at 10:54 am  #1264781    

mrkenney

I’m afraid I received an email from Dr. Ion Cotarla informing me that all the slots for Gastroesophageal cancer have been taken nationwide on this MEDI4736 study (they are accepting patients only for the waiting list).

July 4, 2014 at 11:10 am  #1264782    
Dr West
Dr West

I’m sorry. We’ve generally found that the extreme interest in immunotherapy trials leads to it being a race to get patients on trial before the trials close, often very rapidly.

-Dr. West

August 2, 2014 at 1:34 pm  #1265235    

bethw

Hi, I’m new here! Been following Mike’s progress — was so excited to see his post re latest scans. I do have a personal interest in MEDI4736, too…

I have Stage 4 lung cancer and am in a clinical trial of MEDI4736 and tremelimumab at Moffitt Cancer Center in Tampa. Not where Mike is reponse-wise (yet!) but all my mets that they’re tracking — brain, adrenal gland, 3 smaller lesions/lymph nodes — have shrunk dramatically. My primary tumor is not precisely measurable, I’m told, b/c I had radiation on it earlier this year and edges are fuzzy/blurry on CT; it’s also not a study “target lesion” b/c of recent radiation anyway. But radiologist reports in April and June (started treatment in Feb.) called it “grossly stable.” Next scans Aug. 7!

[Sorry, don’t have time to learn the cancer shorthand right now.)

Why I really got on here is to tell Bill about another clinical trial which he hasn’t mentioned and perhaps hasn’t investigated: http://clinicaltrials.gov/ct2/show/NCT01975831?intr=MEDI4736+tremelimumab&rank=1

It’s with the same 2 drugs I’m getting and for people with “solid tumors.” It’s based at Ludwig Cancer Research Institute in NYC. And listing says they’re recruiting.

No PD-L1 testing, but I don’t know if your current treatment would make you ineligible. Listing says this:

“Failed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment.”

Maybe you already know about it, but thought I’d post it just in case you don’t!

Best wishes, all–

Beth

August 2, 2014 at 2:35 pm  #1265238    
JimC Forum Moderator
JimC Forum Moderator

Hi Beth,

Congratulations on your great results so far, and thanks for the helpful information.

Positive thoughts your way for excellent scan results on the 7th!

JimC
Forum moderator


Jul 2008 Wife Liz (51/never smoker) Dx Stage IV NSCLC EGFR exon 19
4 cycles Carbo/alimta, 65% shrinkage
Tarceva maintenance
Mar 2010 progression, added Alimta, stable
Sep 2010 multiple brain mets, WBR
Oct 2010 large pericardial effusion, tamponade
Jan 2011 progression, start abraxane
Jun 2011-New liver, brain mets, add Tarceva
Oct 2011-Dx Leptomeningeal carcinomatosis; pulsed Tarceva
At rest Nov 4 2011
Since then: http://cancergrace.org/blog/jim-and-lisa

August 2, 2014 at 3:42 pm  #1265239    

Bill

Hi Beth!
Thanks so much for reaching out with your experience and info on MEDI7436.
I’ve been trying to enter a MEDI7436 trail — no luck yet. I’m working with Dr. Christopher Azzoli at MGH.
I have a scan scheduled for early September, so we will see if the Docetozel is still working.
– Bill

August 4, 2014 at 11:44 am  #1265271    

bethw

Hi, Bill–

Oh, I thought you were in NYC! Presuming that MGH is Mass General, please note that the MEDI4736 + tremelimumab trial I sent the link for also has a site in Boston. There’s a third site in Buffalo.

The trial I’m in is still recruiting but is strictly for lung cancer patients, which is why I didn’t provide details. Sites are Los Angeles, New Haven, NYC, and Tampa. Here’s a link to info about that study for anyone else who may be interested:

http://clinicaltrials.gov/ct2/show/NCT02000947?term=medi4736+tremelimumab&rank=1

— Beth

August 4, 2014 at 5:10 pm  #1265274    

gigy

Exciting to hear your good results from the trials. Congratulations!
i am off treatment and waiting patiently for PDL1, 3rd phase trial in CA. This is different from the one discussed here. Truthfully, i am very confused with all these trial, i will keep my hope up in the positive way, ***** the one i get must be good!*****

August 5, 2014 at 8:26 am  #1265276    
catdander forum moderator
catdander forum moderator

I don’t want to muck up the conversation frivolously but I just have to…say congrats Beth even brain lesion shrinking! The post rad fuzzies do last a while.

gigy, I think you’re right the one you get’s going to be a good one!

Mike, I hope docetaxel is working well without too many side effects. As I’m sure you know if the side effects are deemed too difficult it’s thought of as no longer effective.

mrkenney, YaY!


My husband, 8/09 53 @ dx stage III squam nsclc R. pancoast tumor
Destruction of 3 ribs, touching brachial plexus.
6/09-8/09 2 core and 1 VATS undx biopsies. Open thoracotomy for 1 positive biopsy (unresectable)
9/09 Chemo/rads curative intent
11/09 MRI by pancoast specialist surgeon spine met found undiagnosed Rad to spine, Chemo continued thru 6 cycles
Tarceva maintenance 2/10
11/10 3cm tumor L lung, undx core bx w/collapsed lung. Gemzar, 12/10 through 7/12
NED 3/12, stop tx 7/12. Remains NED as of 9/16
Unanswerable question. Was it ever metastatic?

August 5, 2014 at 8:40 am  #1265277    

gigy

Hi Catdander (Janine?):

Thank you.
It is worrisome to wait for their selection process without any kind of treatment.
i applied for phs 3 trial, which is a comparison trial with Docetaxol. Phs 2 is strictly PDL1 drug only. i am thinking about changing the program if i can.
Do you know what is the “reasonable time” to be off any kind of treatment?
Thank you for any advise and sharing.
Gigy

August 5, 2014 at 9:37 am  #1265279    
catdander forum moderator
catdander forum moderator

The timing is strictly dependent on the biology of your cancer, whether it’s fast growing (aggressive) or slow (indolent) can only be determined with time. As long as you’re kept under close surveillance most oncologists feel comfortable with waiting.

There are no rules one way or another. In the following quote Dr. West makes a suggestion for a treatment break. The circumstances are different but the idea of being without treatment is the same. “There’s a point at which the cancer can’t be knocked back down with treatment or the person is too sick from cancer to take tx. The general principle I follow is that if we can’t feasibly be treating for cure, I favor the least toxic approach to control the cancer over the next significant chunk of time (say, several months). If the cancer is indolent enough, the least toxic approach may just be ongoing surveillance with a plan to intervene when it looks more like there’s an actual risk of cancer-related symptoms in the near future, as opposed to giving potentially side-effect inducing chemo that may well be worse than the underlying disease” http://cancergrace.org/topic/no-more-stable/#post-1262955

Yes, I’m Janine


My husband, 8/09 53 @ dx stage III squam nsclc R. pancoast tumor
Destruction of 3 ribs, touching brachial plexus.
6/09-8/09 2 core and 1 VATS undx biopsies. Open thoracotomy for 1 positive biopsy (unresectable)
9/09 Chemo/rads curative intent
11/09 MRI by pancoast specialist surgeon spine met found undiagnosed Rad to spine, Chemo continued thru 6 cycles
Tarceva maintenance 2/10
11/10 3cm tumor L lung, undx core bx w/collapsed lung. Gemzar, 12/10 through 7/12
NED 3/12, stop tx 7/12. Remains NED as of 9/16
Unanswerable question. Was it ever metastatic?

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