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July 8, 2012 at 8:08 pm #20455
Quick update, after 2nd second of Remicade, all colitis symptoms are gone, and I’m eating everything that’s not nailed down (still on hydrocortisone for adrenal insufficiency–seeing onco-endoc this week). But we still need to figure out next course of mel treatment.
Question: Given the scarcity of seats in Anti Pd-1 trials and the strict guidelines surrounding eligibility, is there any consensus of a time-frame for when anti PD-1 drugs might receive FDA approval? I’ve heard so many positive things from people in the trials, what are the chances of the drugs being fast-tracked for approval? Do the trials have to reach stage III before that can happen?
KarenJuly 8, 2012 at 11:16 pm #55331jamesaParticipant
I have read that BMS pd1 drug phase 1 was so successful that BMS plans to ask the FDA to skip Phase 2 clinical trials & then go straight into Phase 3 trial. The article stated that the Phase 3, BMS Pd1 trial for melanoma patients would start in 2013.
Given BMS PD1 Phase 3 trial for melanoma patients started in 2013, then I would surmise the trial & data collection would be 2+ years, and then it will take more time to get FDA approval.
Wishing you the best,
JamesJuly 9, 2012 at 6:28 am #55332
That is the best informatin we have as well. You never know with these approvals. It may gain faster approval with use for lung cancer first. No one knows, even BMS how long it may take but probably a year or so is correct.July 9, 2012 at 2:06 pm #55333 I notice you both reference BMS; what about Merck? Are they no longer running Anti PD-1 trials??
KarenJuly 9, 2012 at 2:27 pm #55334
I haven’t been able to get an answer from Merck about this, Genentech has just begun its trials. We know the most about BMS and that isn’t much!July 9, 2012 at 3:54 pm #55335jamesaParticipant Here is some info on the Merck PD1 trial:
It is a Phase 1 trial with 179 people. It appears that this trial’s completion date is January 2015. That seems like a lifetime away for people with active disease!!!
My understanding is that this trial is full with waiting lists. It would be wonderful if anyone who is participating in this trial would post so that we would know how effective is Merck’s pd1 drug.
Estimated Enrollment: 179
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)July 11, 2012 at 10:30 pm #55336FeistyDParticipant
I am on the Merck anti-PD1 trial (MK 3475)!
I have NSCLC, not melanoma, but I have met some of the melanoma patients in the clinic, and they seem to be having success. One man’s tumors had disappeared to the point where they couldn’t find any tumor to biopsy (they ask to do biopsies after 12 weeks). One woman had to suspend treatment because of a thyroid issue, which is the major side effect. The nurse told me 4 out of 30 on the trial were having the thyroid issue. I haven’t had my first scans yet, but I feel different (no cough or pressure in my lungs). In fact, I feel NORMAL, which to me is great! I have read the drug works primarily on those whose tumors express the PD-L1 ligand. My doc told me mine do, so lucky for me, I guess (if I weren’t in this trial, I think that would be a bad thing). I will be happy to update everyone after my first set of scans in August.July 12, 2012 at 9:32 pm #55337
Thank you Feisty, how’d you find us? We are here to support you too! I’ve heard this is working well in Lung Cancer and may be approved for that first. We’ll love to hear your updates. Hope things continue to go well!July 18, 2012 at 1:42 pm #55338 Thank you everyone for your replies. This is the first time I’ve been able to log in since posting…both on my desktop at home and from my iPhone.
It’s so frustrating to wait for the “golden ticket”, which might not even be a golden ticket at all! You are right, Catherine, the restrictions are so…restrictive! All my largest mets are on prior-radiated skin, that’s excluded. My largest one on NON irradiated skin was removed because there was no sign of any new cohorts opening up. so I don’t have “measurable disease” as part of their requirements…even though I have mm all over one side of my face, neck, in my ear, and now spreading farther up into my scalp…we’re “growing” another one (not cryo freezing and not applying Aldera,) just in case.
Remicade was my miracle drug for the colitis, and now I’m tapering off the hydrocort. for the adrenal failure. Now to decide next treatment…
i’m seeing Dr. Halpern, (derm at Sloan) today…he’ll freeze and I really want to look into surgically removing the mets inside my ear…not on earrdrum…yet, but it really worries me!
KarenJuly 23, 2012 at 11:20 pm #55339rbruceParticipant
I have been on Merck’s AntiPD1 at UCSF for 20 weeks now. My 12 week ct scan showed a 40% tumor reduction in lung Mets with no change in my rib and lymphnode mets. Side effects have been some muscle, bone and joint pain as well as a slight rash on my chest and a bit of fatigue. I have met a number of people on the Merck trial also having good results with little or no side effects. RobertAugust 7, 2012 at 9:53 am #55340LynnLucParticipant I am in the BMS Anti PD 1 trial at Moffitt. I am week 97. The trial is 30 months long…getting booster infusions every 3 months- the first 24 weeks of the trial I had it every other week… NED 2 years and 4 months stage 4.
My thyroid died and I am on Synthroid…I was told its a positive sign..so its great trade off…as we age that thing slows down and stops working anyways. They didn’t take me ot others I know off the trial because of it. I had some achy knuckles and about a week after each treatment I would have flu like symptoms that last a couple days. Recently no flu like symptoms…no problems at all. I did have peeling skin on my hands and feet…it started as a small blistery rash in December- lasted 4 months…now just peeling skin on hands…no blisters. Feet are fine.
Yes I heard that they will probably approve it for Kidney cancer as well before its approved for melanoma…bur wondering if it could be used as off label for melanoma…August 7, 2012 at 11:01 am #55341
Once it is approved (I heard lung cancer) it can be prescribed off label. But whether insurance will cover it for melanoma is another question. Glad to hear you are doing well!August 20, 2012 at 11:16 pm #55342margaretrogers57Participant My husband is looking for a trial of anti-pd-1 with an ocular primary. We’ve done yervoy with slight progression @ 6 months, but stable until then. Someone said they may have an ocular cohort soon. Right now he’s on a mek trial with selumetinib and has seen some shrinkage and rest stable. We’ve just been on 1 months. Will continue that until progression then would like to do anti-pd-1. We’re currently @ vanderbilt in nashville, but have also had lots of treatments @ emory in atlanta. Would have to stay close to our home in Chattanooga, TN. If anyone knows of upcoming trials, please inform. Thanks and gl to all the warriors. Margaret RogersAugust 20, 2012 at 11:22 pm #55343 Margaret,
I just posted the one that may have openings at Sarah Cannon, with Dr. Infante.
Let me know if it works out for you.
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