Are you currently (or have you been) in a Clinical Trial?
Comments
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Katty- Phase 1, is it certain that you would get all three study drugs? And would they be able to tell after just one month whether your tumors are responding?
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There are already 23 patients at MDA in this study and my onc seems to think that he would have enough information in 1 month to know if we should proceed with nivolumab and the other FDA approved immunotherapy drug. He mentioned that he would proceed with those drugs if I had a greater than 10% response, but that is something I need to get clarification about. I'M not clear on what happens if I have a less than 10% response. I thought it would be in the paperwork that I brought home but it isn't, and my head is still spinning from all of the information I got but didn't really hear yesterday.
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Ooh, 23 patients, isn't that more than the numbers who were in your trial? I would surmise that they are probably seeing some good (if preliminary) responses with some of these people. It's not a just-starting-up phase 1 trial, and they probably are not going to be giving you way low levels of the experimental drug, having already treated at least 23 people (including others at the different trial sites). They know you got a good response in the last trial, so just need to tweak the immune system a bit.
Side effects? I've read that two checkpoint inhibitors have more SEs, of course they also get a much better response rate. And then add in the experimental drug, need to make the response strong enough so that the cumbersome procedure is worthwhile.
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Cure-ious, I was the only participant at MD Anderson (not sure how many were worldwide) ; he just added someone else recently! They are giddy about my response to the trial, since apparently I was doing far betters than others on it. Go figure. Now I flunked! Just kidding...
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If you were literally their only patient, then they have a 100% response rate!
Is this your trial? It just started a bit over a year ago:
https://clinicaltrials.gov/ct2/show/NCT03444753
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Cure-eous, it looks similar, but my informed consent paperwork doesn't have the gov't ID number on it. I'll check with my coordinator on Monday.
The description of the study you posted above is:
An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
And the description on my consent paperwork is:
A Phase 1 study of BMS-986299 as Monotherapy and in combination with Nivolumab and Ipilimumab in participants with advanced solid cancers 2017-1041
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Kattysmith I was surprised and so sorry to read about the progression you experienced while being on the trial drug that seemed so promising. I was so hoping it would have produced a long lasting solution for you and all of us.
I hope this other trial you're joining works out better for you.
Big hug
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Elizabeth--I would pair crizotinib (if you can get it donated or otherwise covered) with abemaciclib or palbo. i am on abemaciclib and have been wanting to add crizotinib but, yeah, it's hard to get off-label because of the high cost.
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Not sure where to post this but let's try it here.
The latest issue of Cell has two interesting papers.
Paper 1: This paper shows that Fulvestrant does not work as thought (at least not precisely). The effectiveness of the ER degraders in this category (including the new SERMs) is not related to how well they destroy the ER receptor, but rather how they interfere with slowing down its actions and mobility in the nucleus. They say this class of drug can weakly stimulate the activity of the ER that is not destroyed. It sounds like they conclude that the more effective drug just slows the ER down so it can't get on the DNA to turn on the genes. This should provide a new way to evaluate how well different drugs in this class work and to design the optimal drug- does this also explain why some studies are showing that it is more effective to combine Faslodex with an AI, rather than use it alone?
https://www.cell.com/cell/fulltext/S0092-8674(19)30689-0
Paper 2: This is for KattySmith ( and all of us that want to use immunotherapy in the future). This paper shows that interferon can have opposite effects on the cancer cells and the immune cells surrounding the cancer. They show that fixing a link involving the TRAIL receptor (not sure how that was done), it can reverse the effect, and basically makes immunotherapy work for cancers that are non-responsive, or in cases where it did work but then the T cells crapped out. They indicate this improvement makes the immune system work regardless of the tumor burden in the animal. Below is a link to the summary and then to the paper.
https://medicalxpress.com/news/2019-08-key-cancer-...
https://www.cell.com/cell/fulltext/S0092-8674(19)30784-6
U Penn is testing one possible compound (a JAK kinase inhibitor, Itacitinib) with Keytruda in some solid tumors.
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Hi All,
I've had a few days to slow down, take deep breaths, read a good mystery book, and digest everything, including the excellent, helpful advice and comments from y'all. Cure-ious, your informed enthusiam for this new trial is infectious, and your ability to cut to the scientific chase and clearly explain the possible pros and cons and how things work would be the envy of any researcher and oncologist. You are definitely one of my lifelines in this MBC version of "So You Want to Be a Millionaire."
We all know that there are no guarantees and no easy choices at Stage 4, and although I am not a fatalist, I am a cautiously optimistic realist. When it looked like I was at the end of the road as far as conventional treatments last October, my MO (who is leaving MDA this week for another position elsewhere - wah!) steered me to his colleague in clinical trials with an eye on one or two trials that looked like they might be the most aggressive and effective as far as my liver mets were concerned. My MO was concerned - me too!- that my liver might quickly get out of control and that my QOL would start declining. So I prepared for those, but when I went for my first meeting with the study chair, BIM BAM BOOM, there was this new opening in the cool, new immunotherapy trial and faced with a team that was pushing for my enrollment and they needed to know right away or I'd lose my spot, I signed the consent form. Then, I went home and melted down, accused them (to myself) of only wanting a lab rat for their shiny new trial, convinced myself that they didn't have my best interests at heart, unlike my MO etc. etc. etc., so I made sure that my MO was on board with this change...and he was.
So, off I flew into the wild, blue yonder not knowing what I'd encounter or if I would be coming back. It was intense, overwhelming (especially the scheduling which is just effing crazy exhausting the first cycle/month) and incompresensible at times. Clinical trials are not like regular orderly conventional treatments - they are a beast at first, so looking into the maw of this new one scared me a little again. And the scheduler didn't help because it's a massive amount of info all at once and she kept adding in all of the scenarios that weren't possible, so it got confusing. We're having to work around my hubby's two cataract surgeries in Sept., so it's cray cray.
The plusses are that my blood work and general health and appetite are good. I feel that I have a couple of months to give this trial a chance to kick-start my immune system, so unless I change my mind at the 11th hour, off I go again into the wild blue yonder. I can always bail out later and try another option if need be. In the meantime, I have a birthday coming up and will raise a glass or two of Tanqueray Rangpur Gin and tonic with lots of cherries to my health! Cheers!
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Glad you feeling clear and focused , enjoy tour birthday and gyn xx
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Kattysmith- cheers! To health and happiness and a great trial
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Happy Birthday, Katty! Cheers to you! I will toast your gin with a glass of bubbly. I hope the trial does just the trick on those liver mets. Fascinating that they inject the drug into the tumors. Hybrid of local and systemic theroay
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Happy Birthday Kattysmith! I am celebrating with a powerful homemade slurpy soup of frozen mixed berries, almond milk and quercitin! Yummy
May you happily live to a delightful old age!
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Yum, Frisky! Anything frozen sounds great right now; it's 100 degrees out. Bleh.
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kattysmith, good luck with your treatment. I hope you have a big breakthrough and I hope you know youre doing important work for humanity at large.
Cure-ious, thank you for sharing these articles. I found this one but was having trouble understanding it:
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Pretty promising for the future of chemo often used in MBC
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Thank you for being a Trail Blazer, Kattysmith! Praying for an outstanding response to this new immuno. Treatment for you. Please continue to share your treatment process with us. So interesting! Not much for clinic trials in my location so great to learn about trail opportunities out there.
“Cure-ious, your informed enthusiam for trials is infectious, and your ability to cut to the scientific chase and clearly explain the possible pros and cons and how things work would be the envy of any researcher and oncologist.“ - I love this! Your name is so fitting and I love that! Thank you.
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On August 20, Pat posted on the Ibrance thread about a trial of Opdivo and Yervoy taking place at Southwestern in Dallas. I posted that it's also starting at Dana Farber. The doc in charge at Dana Farber said it's also going to start up at U of Pittsburgh (and she said some other places but didn't name them.)
This is an immunotherapy trial combining the two named drugs. It requires a recent genomic report (think F1 and others like it) and you need to have 10 or more mutations showing up on that report.
Hope this helps someone.
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A new paper out today in Cell identifies a new protein, DHX37, that shields TNBC cancer from the immune system, providing another target for drugs to make immunotherapy work better.
https://news.yale.edu/2019/08/22/genome-screen-unc...
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Hi Cure-ious. Thanks for sharing this. Did they use TNBC in the mice models for a particular reason? Also I’m really digging your new avatar
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thanks Sky, I am the least computer-savvy person, but I finally found where to upload pictures
I didn't read the paper in detail to know why they chose TNBC, I'd guess it was because its somewhat more sensitive to immunotherapy than ER-positive breast cancer and they wanted to use a solid tumor model.
I was more interested in what DHX37 is, and its an RNA helicase, so I don't this this would be at all drug-able; there are a ton of RNA helicases in the cell and no selective inhibitors. they said they had some other candidates pop up in the screen, hopefully they find something that can be acted on.
Same Cell issue has 3 papers detailing how 3-5 day fasting helps kill immune cells that are surrounding the tumor and makes chemo more efficient. A review of the work by Valter Longo, which some here are following his view of the fasting story.
i'm not a big fan of that - if you weaken the body the cancer cells die off more easily, however the steroids you have to take to survive the chemo also strengthen the cancer cells, so there is a trade-off there, plus, some fraction of the cancer cells will always be in an arrested state and not be growing, so always some are able to survive the chemo. So none of this is going to be a cure. Z did do the Longo fasting and her doctors were amazed how well her chemo worked- but still wasn't good enough to even give her a long remission.I'd prefer they find a drug to unshield the cancer, or convert the protecting immune cells to tumor-killing immune cells.
For a drug like Piqray, where people can potentially be on it for a long time, I am a big fan of the daily short evening fasts just to burn down the sugar levels and get into fat-burning mode by bedtime. This has great potential to boost the treatment and is not going to significantly impact quality of life But its hard to see how prolonged 3-5 day fastings surrounding every chemo treatment would really lead to a long remission period so as to make up for the impact on quality of life?
Ha! you didn't even ask about any of this, but anyway, there's my rant of the day...
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Skyguy- How is your mom doing? She is coming up on her one-year anniversary!!!
Did they decide to remove the original tumor? Is she having any side effects?! Hope you celebrate!!
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RACHEL1: An Interesting New Clinical Trial (MD Anderson only):
Here is a new phase 1 trial for ER-positive MBC, which involves immunotherapy, in the form of a new hybrid molecule that blocks both PD-1 and TGF-beta, and is administered alone or with radiation.
Radiation blasts open tumor cells and can stimulate an abscopal effect, where the immune system targets cancer cells throughout the body, and so it works synergistically with immunotherapy.
What I like about the trial is that they've opened it up to everyone- you have to have had a minimum of one endocrine therapy, but not more than five chemos, which obviously covers a very broad range of people. What seems unusual, unless I am missing it, is that it does not require PDL1 expression or high tumor mutation burden.
It seems tempting to try this, if you need radiation anyway and its convenient... Presumably you'd go back to regular therapy after the radiation is done?
https://clinicaltrials.gov/ct2/show/NCT03524170
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Anybody still hanging in there on clinical trials?!
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Not me any longer, Curious. I tried 3 times/ 3 different dosages of Alpelisib. My body just couldn't handle the strict rules regarding treating SE's but I stayed on the fulvestrant arm for 10 months. Now I'm on low dose Xeloda while waiting for the new trial for oral fulvestrant to open. It's been on hold since May 1. Not sure what the hang up is. But for the most part Xeloda's not treating me too badly so I'm happy to stay on it.
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Dee, are you going to try a SERD?! that would be cool, and also ten months on Faslodex alone is pretty nice given no SEs..
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A new approach is out for a different immunotherapy- in this case, they examined why NK (natural killer cells) are kept at bay by cancers, and discovered its because they bind to a molecule called Activin. It turns out a natural hormone, follistatin, binds Activin and releases/activates the NK cells to go kill cancer.
https://www.sciencedaily.com/releases/2019/08/1908...
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GG27, what is trial# of that oral SERD?
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SandiBeach, A Phase 1/2 study for the safety, efficacy, pharmacokinetic and pharmacodynamics evaluation of SAR439859, administered orally as monotherapy, then in combination with palbociclib in postmenopausal women with estrogen receptor-positive advanced breast cancerBCCA CODE: BRTSERD (on hold as of 1May2019)
I am hoping to get on this trial but if Xeolda is working do I go off that? My MO is on sabbatical until January so I doubt i would change before then. My next scan is at the end of October & I didn't get my TM's this time so not sure if it's working or not.
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