Anti-PD-1 Immunotherapy Clinical Trial Update - 1246967

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tikicat
Anti-PD-1 Immunotherapy Clinical Trial Update - 1246967

Update on my anti-PD-1 clinical trial (MK 3475): I had my twelve-week scans this week. Everyone, including the doctors, trial nurses, and my family and friends, was very anxious to see the results, as I am the first of the lung cancer arm to get my scans at my clinic. And....ta da, almost seventy percent shrinkage of my tumors with no new mets! I had a feeling the results would be good, because I just feel better.
I feel normal, like my old, pre-cancer self. No side effects so far, no nausea, no thyroid or liver problems, and my hair is growing back. Most of all, I have hope! I love modern medicine! Clinical trials save lives!
:-P

certain spring
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

That is seriously nice news, Feisty D, and worthy of your name. Thank you for the update.
Must be quite strange to have everyone jumping up and down to see your scans!
I was wondering if you ever came across Justtina - you and she were discussing the trial on an earlier thread?
http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/
Hope you continue to feel better.

catdander
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

FeistyD, That is seriously good news. I'm so impressed with you and our other members for taking advantage of testing these new drugs.
Ta Da indeed!
Janine

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

That's remarkable, and it's extremely encouraging for you and as a lead for how someone with spindle cell/sarcomatoid lung cancer, a pretty rare subtype, might be treated effectively. I'm very happy for you and hope this is a great lead for many other people as well.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

Jazz
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

WOW!! That's great news! Very thrilled for you! Long may you run on this trial. Please keep us posted!

Jazz

graceabchen
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

It is exciting to have a real example of excellent response of this rare form of nsclc in the anti-PD-1 clinical trial. Although anti-PD-1 Immunotherapy was a big news from this year’s ASCO, the data for nsclc were just average. The objective response rate was 18% (14 of 76 patients), as reported at http://www.nejm.org/doi/full/10.1056/NEJMoa1200690 . I have an impression that Immunotherapy works best in the maintenance setting. May be this phase of trial will push it to the first line. I also notice that this trial also includes the anti-PD-1+tarceva subset. This will open a new window for the EGFR+ patients. I did not see the trial criteria exclude patients who have acquired TKI resistance. Will these patients qualify for the trial? More importantly, can this combination actually treat the acquired resistance?

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

I don't know answers to those questions at this time...I believe that Bristol-Myers Squibb is still clarifying their future research priorities and plans.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

ssflxl
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hello,

I am unable to find this clinical trial on MK 3475 in US - only available in Australia in the clinicaltrials.gov website. Is there any difference between this and BMS?

thanks

ssflxl

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

I heard the Merck trial will be reopening with new arms combining anti-PD-1 with chemotherapy for melanoma and NSCLC.
I don't know about the difference between the BMS and the Merck anti-PD-1 drugs, but I believe they are quite similar. I'm just a survivor, though, not a biochemist or oncologist. You should really ask an expert.

Jazz
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Ssflxl,

FeistyD is enrolled in the Merck trial at the Angeles clinic in LA. Her trial doesn't seem to be recruiting any longer however it does appear that the MDX-1105 (also known as BMS936559) trial is recruiting there. The difference is that it's an anti-PD-L1 trial, which is trying to inhibit the ligand... See Dr. Brahmer's explanation in the podcast on immunotherapies - it's the other side of the coin of the anti-PD1 therapy.

This doesn't answer your question as to what the difference is, but thought you or someone else may be interested in this. Usually the difference is the actual molecule (like the difference between Iressa and Tarceva), otherwise the companies would be fighting over patenting it.

As I mentioned to blue skies on her thread, the phase 1 trials at johns Hopkins (BMS936558 + Tarceva or avastin or certain doublets) filled up as soon as they opened...

Jazz

ssflxl
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Dear Jazz,

thanks for your comments. I have already put the BMS trial into my folder for future considerations. It's good to hear from FeistyD of such good result with the drug.

ssflxl

certain spring
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

There was an earlier discussion of comparable trials here:
http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/

certain spring
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

FeistyD, inquiries are being made on another thread as to how you are getting on?
http://cancergrace.org/topic/afatinib-cetuximab-trial-user-group/page/6/...
Hope all is well and you are still getting good results from the trial. Very best.

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Thanks for asking- I'm still here! I have done 10 infusions of MK 3475 so far. My second set of scans in October showed continued shrinkage of my lung tumors and no new mets. I have my third set of scans next week (brain MRI and CT scans), so I'll let you know how those go. My side effects have been minor- some itchy red spots on my legs and hand, some muscle pain, and some fatigue. I'm still working full-time and trying to keep fit. I imagine they are examing my blood tests and scans pretty closely to see why I am doing so well. I have no known mutations, which may actually be a factor in my response. The doctor asked me last time if I had been a smoker (I was 30 years ago, for a few years in high school/college), which may also be a factor. Most importantly, my tumors express PD-L1. What a difference a year makes- last year I was bald, and could barely walk. Here I am, getting ready for Christmas and going to the gym!

catdander
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

That's great! The last sentence is the best. I look forward to more excellent updates!

certain spring
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

How wonderful. Thanks for responding.
It is a very nice thing to confound people's expectations, and one's own!

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Great to hear! Thanks for the encouraging update.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

Jazz
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Sounds like a Merry Christmas to you, Feisty! We love this news. Best of luck with next week's scans.

The high dose (10mg) sounds like it's working for you. I wonder if there are other NSCLC folks doing alright on the lower doses?

The expanded trial sounds fairly complicated, with randomization to either low, medium, or high dose WITH standard chemo (doesn't mention what agent), or anti-PDL-1 low or high dose. So I imagine testing would be done for PD-1 expression prior to randomization to the anti-PDL-1 arm? Perhaps you can probe your Doc as to what chemo agents might be used in combination? Inquiring minds want to know...

Jazz

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Jazz, You have a lot of good questions. I do not feel qualified to answer. My study doesn't involve chemo at this point. I know the DRUG in my study is anti-PD-1, and the TUMOR expresses anti-PD-L1 (not the other way around). From your signature it looks like you are in California. Why don't you call the Angeles Clinic and talk to one of the the study nurses? 310-582-7900. They are much better qualified to answer your questions.
I also heard from my former onc that City of Hope and USC Norris will be offering anti-PD-1 trials soon, too. If you are in California you have many options. Good luck!

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

I got the results from my latest scans yesterday. My primary lung tumors continue to shrink at a steady pace of a couple of millimeters every checkup (scans every 9 weeks). After six months on anti-PD-1, they are down to 0.7 X 1.6 cm and 1.4 X 1.3 cm. As a comparison, a year ago, after chemo, they were 2.1 X 1.9 and 3.2 X 2.7. The brain MRI was normal. My doctors feel I will continue to respond; basically, I am "on autopilot" as far as my treatment goes. I feel great with minor side effects of some joint/muscle pain and itchy red spots on my hands and legs. My docotr says the response rate is about 20%, so I feel very, very fortunate to have found this clinic and this trial. I would probably not be writing this if I hadn't.

New arms of the Merck trial are open/opening, so if you are interested, let me know.

Merry Christmas to all!

certain spring
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Great stuff. Delighted to hear it. Happy Christmas!

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

That is truly wonderful news! Thanks for sharing, and happy holidays! Hoping that you get more great news like that in 2013.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Update on my anti-pd-1 trial, Feb 22, 2013: Scans and fourteenth infusion of MK 3475. Continued shrinkage and stability- brain MRI shows normal. Ha ha- I'm normal, sisters (they always said I was crazy).
Primary tumors in my left lung have shrunk from 0.7 X 1.6cm to 0.7 X 1.4, and from 1.4 X 1.3cm to 1.5 X 1.2. No cancer detected anywhere else in my body. A year ago they were 2.1cm X 1.9 and 3.2cm X 2.7 with mets on my ribs and pancreas.
There are open slots in this trial if anyone is interested. Now your tumor needs to be tested for expression of PD-L1 first before they will accept you, so you have to have a fresh biopsy and meet other criteria as well (no pleural effusion or active brain mets.) Here's the link:
http://clinicaltrials.gov/show/NCT01295827

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Thanks for sharing that great news and the link... (and don't be surprised if your sisters say that just because your brain MRI looks fine doesn't mean your normal).

I hope you continue to show great results on this study.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

double trouble
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Congratulations! We love good news around here! And people who participate in trials are my heroes, so on behalf of all of the future patients you're helping with your selflessness and willingness to try something new and perhaps a bit risky... Cheers! And thank you very much.
Debra

marisa93
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

FeistyD,

Thank you for sharing such good news, that is great! And how wonderful you are to participate in a trial to help advance the treatment of lung cancer:)

Take care and best wishes,
Lisa

catdander
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Oh FeistyD, I just can't say how happy and excited I am to hear you've gone from being in such straights a year ago and now feel normal. What a roller coaster for you and your family I know have been on. I'm sure your friends are just speaking of your wild spirit and I hope the drug wouldn't take that away. :wink:
I will try to stay calm and collected about the possibilities for this drug, but darn you're making it difficult.

Yeehaa,
Janine

gn21
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Fantastic stuff. Congratulations

Gail

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

FeistyD....how are you doing on the Merck pd1 trial? You have not posted for such a long time.

Anyone know how Feisty is doing, please post an update.

Thanks. Wendy

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi, This is FeistyD. I am still around. I am recuperating from hip replacement surgery a week ago. I was having more and more trouble walking, and it turned out to be a lesion on my right hip. I am still waiting for the pathology report to find out if I will be able to continue with the Merck 3475 drug. So right now I am resting at home waiting to see if I can stay on the trial. The rest of me is stable and feeling pretty good. Thanks for asking. I usually port on Inspire but I still check in on Cancer Grace from time to time.

catdander
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi FeistyD, Good to hear from you! Hope the new hip works better and you able to stay on the trial.
Janine

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Great -- thanks for the update!

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Feisty please keep us updated on whether or not you will be stay on the trial. Clinical trial rules are confusing to me. Why would Merck kick you off the trial?

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

They would kick me off the trial if they considered this lesion to be a sign of progression. My oncologist is trying hard to keep me in the trial on the grounds that the rest of me is stable (after about 80% reduction in the size of my primary lung tumors). Apparently the lesion has been there for a while, but it had been causing me more and more pain, to the point of not being able to walk. The orthopedic oncologist who did my hip replacement told me I was very close to fracturing my hip, so I really had no choice- I had to have the operation. I'll update you all when I have some answers.

laya d.
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Thanks for the update, Feisty. . .and have my fingers crossed that you can remain in the trial.

Laya

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Feisty,

Thank you for explaining about clinical trials.When will you know the decision whether or not you can stay on the trial? How much longer do you have to wait....that must be sooooooooooo stressful.

Wendy

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi Everyone,

Thought you might find these articles regarding MK 3475 informative:

http://www.dddmag.com/news/2013/11/merck-drug-improves-melanoma-survival

http://www.dddmag.com/news/2013/11/merck%E2%80%99s-drug-shows-potential-...

FEISTY, I hope you and your hip replacement are doing well. Any decision from Merck if you can stay on the trial.

Well Wishes,
Wendy

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

I think there is ample reason to be hopeful about this agent and this entire class of immune therapies for melanoma, lung cancer, and very likely other cancers as well. Thanks for bringing these links to our attention.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

tikicat
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

At this point, I am off the Merck trial. The pathology report from the surgery came back as "consistent with leiyomyosarcoma" - basically uterine cancer ??? - another very rare cancer, which makes no sense to my oncologist. UCLA pathology is going to review my original biopsy slides and try to determine what is going on. Do I have another extrememly rare cancer as well as the spindle cell carcinoma, or did the pathologist misdiagnose me? I have been a strange case all along. My oncologist is going to appeal to the FDA to allow me to continue to receive the drug. But in the meantime, I am at home recovering from the hip replacement surgery and not receiving any other treatment. I don't really have any other symptoms. The Merck drug has been shown to have a durable response- maybe I don't even need it anymore. So that's where I am at. Despite this setback, I am grateful for having been on the trial for the past 18 months and remain hopeful about immunotherapy.

carrigallen
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

In cases like this, I would generally agree with external pathology review - it is not uncommon for lung cancer to aberrantly express proteins seen in other cancers, resulting in weird diagnosis, like you describe. It sounds like you have had a good run of 18 months, let's hope the future treatments go well too!

Jazz
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Feisty,

Best of luck with the FDA. I'm glad you have a proactive oncologist in your corner. And I hope the pathologists can get your mysterious situation straightened out, and that you continue to be symptom-free and that your response lasts a long, long, lonnnggg time.

My results are in and I'm PDL1+ so after a baseline CT, PFT, etc. hopefully I'll be set to start!

Happy Thanksgiving, everyone!

Jasmin

ssflxl
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Jazz,

Congrats for testing + for PDL 1. i was going to suggest that you try the Phase 1 anti-PDL 1 trial here in NCAL - at Redwood Regional Med Group in Santa Rosa. their trial doesn't require positive biopsy for PDL 1. their agent is made by EMD Serono - Merck subsidiary, not the same one as Roche. Anyway, I don't qualify for that trial because I have to fail chemo and I haven't had chemo before.
I am waiting for the CO 1686 Phase 2 trial to open in Stanford. I will be getting my biopsy to check for T790M mutation on 12/6, and will let all of you know result. if I am negative, then I will start chemo, after the holidays.

Happy Thanksgiving to All

ssflxl

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Thanks for the updates. Good luck to both of you!

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi Feisty,

I was wondering how you are doing? I hope that your hip is doing well.

I also hope that your next MRI & CT scans show that Merck's PD1 drug is still working for you.

Did you get the results of UCLA pathology reviewing your original biopsy slides? Also, did the FDA approve you staying on the Merck trial? If not, what are your treatment plans now?

Take care and I am sending positive thoughts your way!

Wendy

cthornton
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi

I am trying to find an open Pd1 trial for metastatic melanoma. I did ipi from last Sept to this July and just progressed after one round of IL2. Any information about a PD1 trial would be greatly appreciated !!

Dr West
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Unfortunately, we really don't have a critical mass of people here who are discussing melanoma. I might suggest the website for Aim at Melanoma, if you don't know of them yet.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Associate Clinical Professor
Medical Oncology
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

wendyp
Reply To: Anti-PD-1 Immunotherapy Clinical Trial Update

Hi Feisty,

I was wondering how you are doing? I hope that your hip is doing well.

I also hope that your next MRI & CT scans show that Merck’s PD1 drug is still working for you.

Did you get the results of UCLA pathology reviewing your original biopsy slides? Also, did the FDA approve you staying on the Merck trial? If not, what are your treatment plans now?

Take care and I am sending positive thoughts your way!

Wendy