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November 26, 2013 at 1:40 pm #21685
After a couple of months of attempting to get into an anti pd 1 trial, (and being disqualified/randomized to chemo), yesterday I began the PDL trial @ MSKCC. The past two months have been filled with disappointing outcomes, a few false starts and lots of travel to NYC, but I have much personal support from family and friends (and a big thanks to Catherine and Jonathan).
I had been treated @ NYU for the past five years (and leaving my team still brings tears to my eyes..) NYU has the Merck phase 2 crossover trial which I was disqualified from due to having been previously treated with two out of the four randomized chemos. In addition, Merck has closed this trial. I went on to enroll in BMS phase 3, more scans, MRI’s, and biopsies. (My scans also showed diminishment/disappearance of two new lesions..Yervoy still on the march) but was randomized to chemo. I opted out and headed north on 3rd Ave. to MSKCC and began the enrollment for PDL. Three days in NYC last week for EKG’s, MRI’s, scans more biopsies…oh yeah and a false positive pregnancy test…I was just about to go in for a CT scan and was told over the phone by one of the trial nurses that I had a positive pregnancy test…did I mention I just turned 57? So further scans were suspended while they retested.
So to bring this down to some bullet points for anyone interested in this trial..
ekg, scans mri, biopsy and good liver function while on other immunotherapies
After the first week…(I will be in NYC everyday this week except Thanksgiving…blood work, follow ups etc) then treatment every two weeks…scan @ 6 weeks…biopsy @ 8 weeks.. scan again @ 12 weeks and if all goes well..continued treatment.
My regular immunologist, Naiyer Rizvi, (whose specialty is lung cancer) explained there is not a lot of difference between anti pd 1 and PDL and they are trialing PDL on about 30 melanoma patients and hundreds patients with other cancers…but between lung cancer and melanoma they have been seeing the most promising results. He also explained that melanoma and lung cancer share something in common with the way the immune system turns on and off certain onc genes…the point is he was very willing to have a layman’s conversation with me on how PDL works…
MSKCC is an amazing medical machine and the volume of folks being treated there is equally amazing. It’s about a five hour round trip for me but there’s something about that NYC energy..as a matter of fact I must get going and head to Bridgeport to catch the 10:51 to get in for a follow up…I’ll post more as I go along.
I wish everyone all the best for Thanksgiving
MarthaNovember 26, 2013 at 6:36 pm #63042MathewRParticipant
Martha, I wish you the best of luck with the new trial. Are you able to provide a trial number (NCT . . .) for those interested in more info? Happy holidays.November 26, 2013 at 8:14 pm #63043Catherine PooleKeymaster Martha, I’m not finding this either on Clinical Trials.gov. It is the Genentech right? I think BMS dropped their PDL trial. I found this: A Study of The Safety and Pharmacology of MPDL3280A Administered in Combination With Vemurafenib (Zelboraf®) in Patients With Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma
That will be interesting! But please share the NCT number. Thanks! and I’m so happy things worked out thus far.November 26, 2013 at 10:35 pm #63044
The number is NCT01693562 (yes, hard to find on clinicaltrials.gov)…drug company Medimmune..drug number MED14736…the protocol # @ Sloan is 12-179…it’s listed as a phase 1 study for advanced solid tumors..Neal Segal is the investigator..on clinicaltrials.gov,…it does not give specific locations..only the states the trials are being held in. And yes Catherine, BMS did drop their trial to put all their resources into pd1. I am not sure if Genetech is running a trial, but their is one other additional company trialing as well.
As a side note…I failed to include possible side effects of PDL..really none….possibly milder and easier to tolerate than Yervoy…which does have it’s challenges but are usually manageable.
I had a follow up today…as one can imagine totally unremarkable…just wait until they see my cholesterol after Thanksgiving!!
Hope that was helpful,
MarthaNovember 28, 2013 at 9:59 pm #63045Andy123Participant
thanks much for the update and congratulations on enrolling in the promising pd-l1 trial.
I understand from other sites; that this trial is also going to get closed soon and so you’ve been quite lucky – rather i’d say your continued efforts paid off
What dose levels are you on for the MEDI-4736? We’re looking at this trial for a family member. And would you know what % of patients have responded so far on this trial? Possibly Dr. Rizvi or the clinical nurse would know.
And what kind of toxicities / side-effects have the patients experienced so far?
Best wishes for the trial and hope it works for you very well as it has for many other pts on these drugs.
AndyNovember 29, 2013 at 9:36 pm #63046
Yes..I do feel lucky to have gotten on this trial and I just want to say, because of info posted on this site and additional information from a friend I have on this site, I was able to cobble together the info I needed to bring to my onc @ NYU, who then made the necessary contacts for me @ MSKCC. I know there was a sense of urgency to get me enrolled, not because of my status (I am stage IV with a slow tumor burden) but I think because of the status of the trial…so I hope your family member can get to MSKCC as soon as possible.
My doctor during this trial is Rizvi. I have only met him once. I also met Neal Segal, the lead investigator of PDL, as well as the head of immunotherapy. Upon meeting Rizvi, I liked him. Willing to have an unhurried conversation and though my initial questions were few, he addressed them all. I am the type of person who will go in with a 3 x 5 index card with questions. I don’t have hard numbers, but from what I understand, the responses are positive, mostly from people with melanoma and lung cancer. My oncologist from NYU told me people who have even partial responses to Yervoy, most likely will have a response to PDL. As far as side effects I am told they are similar to Yervoy…rash…gastro issues etc. Most people tolerate PDL well.
If I can be of any further help to you and your family member in regards to MSKCC/PDL…please don’t hesitate to drop a line.
MarthaNovember 30, 2013 at 4:06 pm #63047Catherine PooleKeymaster
Here is the link to this trial: http://clinicaltrials.gov/show/NCT01693562
Looks like prior IPI is allowed. I have reached out to the company to find out more.November 30, 2013 at 4:30 pm #63048
ps to Andy…my dosage is 10 mg/kg..December 3, 2013 at 7:18 pm #63049erinmay22Participant Martha –
So glad to hear the PDL trial is working well for you so far! I’ve been at MSKCC for almost 3 years now. Did Zelboraf, then Ipi, and Jan of this year started the Merck anti-PD1 trial. I know Dr S and R. A few months ago they pushed me back to my original med onc – Dr Dickson. Mainly because there are SOOO many patients in trial in the ITC and luckily I’ve had good results with minimal side effects. So no need right now to be followed by the trial investigators.
I’ll be at Sloan on 12/5 for my 3 week treatment! It’s pretty amazing when you sit there and see all the patients that go thru there…
All the best!
ErinDecember 3, 2013 at 10:50 pm #63050
Yes…it is amazing how many patients are being treated just on the 4th floor…and how really organized the administration is. I have yet to get the “lay of the land” as far as medical personnel are concerned…I did ask Dr Rizvi who my doctor would be at this point and he said he would be my doc as long as I was on the trial…if they kicked me back to NYU for all things melanoma I would be thrilled. I actually just consider myself “on loan” to MSKCC. As a matter of fact at the “Safe from the Sun” event in 2012, I introduced myself to Dr. Wolchok in case Dr. Pavlick from NYU had to “co-broke” my care with him..he thought the term co-broke was hilarious (but accurate).
MSKCC is certainly on the cutting edge of trials and treatment..and being only 2 1/2 hours away makes it pretty easy to get in and out of the city…I just hope the MTA gets a bit safer…this last year has made me a bit nervous riding the train into the city…
Good luck with treatment on Thursday…I have treatment again on Monday and they’re calling for an ice storm in my neck of the woods…always something
MarthaDecember 4, 2013 at 9:02 pm #63051erinmay22Participant
Hi Martha –
Yeah, my biggest question/complaint about going to the ITC was ‘who’s my doctor?’. I had Dr Dickson for 2 years and then all of a sudden was down in the ITC and seeing a different doctor every visit. Dr Segal was the one who signed me up on the trial. I was totally excited when they kicked me back to Dr D. I appreciate the consistency of care. Although Dr R was growing on me! I didn’t really ask him too many questions. I think at the time when I started the pd1 trial I was a little beat down after failing 2 treatments and a major surgery.
Safe travels! I do feel pretty lucky to pretty much have sloan in my backyard! I am in Jersey City so it’s a quick train ride to WTC and then the E right up to 53rd/Lex. Good luck on Monday! Hope the weather cooperates for you!
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