Are you currently (or have you been) in a Clinical Trial?
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Avelumab is traditional pd-1 based immunotherapy, like Keytruda
Pelareorep is a virus, modified to selectively infect cancer cells and attract the immune system.
From the Oncolytics website:
In non-cancer cells, pelareorep enters the cells but is unable to replicate and the virus is actively cleared In cancer cells pelareorep selectively replicates, and cancer cells lyse/die, releasing additional virus particles to infect nearby cancer cells.
The virus is turned on in a variety of different types of cancer cells because it was designed to sense:
- Defective cell signaling pathways
- A high level of genomic mutations (or mutations in key tumor suppressor genes and oncogenes)
- Cellular stress from chemo and radiation therapy
Pelareorep enhances the body's natural anti-cancer immune response by activating both the innate and adaptive immune systems, converting immune unresponsive 'cold tumors' into immune responsive 'hot tumors'. Cancer cells infected with pelareorep release inflammatory cytokines. This inflammatory milieu activates natural killer (NK) cells and promotes the migration of NK cells, dendritic cells, and T-cells, to the tumor microenvironment which aids in immune cell mediated cancer cell death. Following pelareorep mediated cancer cell death, the release of the tumor and viral associated antigens are taken up by antigen presenting cells (APCs). APCs then process and present antigens to T-cells. This trains the adaptive immune system to recognize and kill cancer cells. An adaptive immune response allows for: existing cancer cells to be eliminated, constant cancer cell surveillance, relapse prevention, and increased overall survival.
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Curious- sounds great! any results from studies yet?
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NKB,
Well, there are so few trials for immunotherapy (IO) with ER-positive MBC that the bar is set very low. So in phase 2 the pelareorep virus plus paclitaxel did not give PFS better than paclitaxel alone, and that PFS was like 3.6 months, which tells you how ineffective chemo is.
Anyway, the pelareorep trial was nevertheless considered a success because the overall survival doubled or more, strongly suggesting that the virus was stimulating an immune response that made all the subsequent treatments work better. So now they add in immunotherapy, hoping for a strong synergy, and if so, to determine if they even need the paclitaxel. For MBC we need a drug combo that gives a decent response rate, which for IO alone is only around 5%. First, get a lot more patients to respond, and then work on improving effectiveness and duration of response.
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Hello friends,
After doing 8 treatments in the last year, I'm starting to get adventurous! Because I'm now super pretreated, I think I'm ineligible for many trials.
But I remain super interested in learning more about CAR-T. I was screened for the program at Fredhuth, cut I am not MUC1 positive, so moving on. I know some folks have done the CAR-T trial at NCI, and that is sometimes works and sometimes doesn't.
Would love any more info from those who have it.
Thanks!
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Dear LedaScout, CAR-T for solid tumors is indeed very interesting but they are not successful enough in solid tumors as they were in blood cancers and lymphomas (where they are believed to produce up to 50% cures in before deadly cancers, time will tell). Now second/third generation of CAR-Ts is coming for solid tumors (too slow!) in combinations with something else. There's hope (like this one: http://news.mit.edu/2019/car-t-cell-therapy-cancer-0711) but mostly all about cancer research is like looking for a needle in hay-stack. What we lack in this "system" is a "parallel track", i.e. right to try out treatment even if it does not make it into clinical trials. What do some stage IVers have to loose anyway? I think science and medicine would benefit from "parallel tracks" a lot, and things would move so much faster when there's initial data, especially when now 75 % or more successful drugs in mice BC models (cures!) do not even reach clinical trials... Saulius
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Thanks Bsandra for the helpful info and the link. Whew... yes, this stuff moves so slow. I'm ready to be a guinea pig for anyone who will take me. Trying to figure it ou!
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Here is something to keep an eye on : Clinical trial number : NCT03970382
Interestingly they are enrolling :148 people.Usually these type of clinical trials start with very small % people ( less than 30)
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Ledascout, you might have mentioned this..but was genomic testing done on a new liver bx?
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Wow, Weareone, that's quite a find. How the heck did you come upon that? It sounds REALLY interesting -- and it's for HR+ people (and I see that the one arm uses Opdivo + their experimental product.) Thanks for posting.
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THanks so much werone. Seeing they just openned at UCSF, so I'm inquiring now!
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WeROne,
Thanks for the info about this interesting trial!
It is California-specific, and one of the investigators is funded by the CA stem cell initiative, so maybe that's why. Sponsored by PACT in the bay area; this company has a very elite advisory board. Trial is available at many of the UCs & City of Hope, and does not seem to require much beyond MBC diagnosis, and otherwise good health. Available till end of next year, and followups will go on for a year beyond that
What they offer patients is remarkable- to identify some cancer`specific antigen in your cancer cells, then clone that into T cells and grow it up to go fight your own cancer, and deliver the CAR-T alone or together with I-O. Totally personalized medicine; this trial seems like it would be very expensive for the pharma to pull off due to all the individual labwork required, but great for the patients! They are testing this in cancers that respond well, intermediate, or poorly to I-O alone, and picked ER+ MBC as one of the latter.
Here is a review of their approach:
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Shetland, scaling back on the boards to enjoy NEAD status and life is great to hear! You had a rough year before this and it is wonderful how well things have turned around. Enjoy!
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Bromelain (from pineapple), Fucoxanthin (in certain seaweeds), and Modified Citrus Pectin (google) may all inhinit FGFR to some degree. This is of course not medical advice.
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Thank you for your understanding JFL. The turnaround does seem pretty miraculous.
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Hey, Luce- Do you know about FGFR effects on immune system? Bromelain is also apparently anti-inflammatory, however, FGFR inhibitors like Erdafitinib can sensitize some cancers to respond to immunotherapy, which would seem like these are pro-inflammatory?
https://cancerimmunolres.aacrjournals.org/content/...
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Seems like the Saci (aka Trodelvy but I hate that name) party is coming to an end. Had scans last Tuesday that showed mild progression. Not enough to get off of the trial yet but these things don't usually reverse course. My next scans will be in five weeks so looking for my next treatment. These days, getting six months more is all good since Saci was very easy to tolerate.
Starting to get worried about the fact that my time on treatments keeps getting shorter and shorter. Was on Xeloda for 26 months, then Ibrance for 20 months, then Piqray for 8 months, then Abraxane/Taxol for 8 months. Likely 6 months for Sacituzumab.
I was also disappointed to hear that I would not be able to get on Enhertu after I have failed on Saci. Apparently, even though the chemo payload delivered is different, since the ADC mechanism is the same, it is unlikely to work. Asked about Exemesthane + Everolimus but my MO didn't think that would work for me. She mentioned a CDK 2/4/6 trial as a possibility. Anyone on this? Hoping I have enough tissue left from my last biopsy to do a Foundation One analysis. I did the UCSF 500 genetic analysis more than three years ago. Hopefully, something new will be in there to target.
Would love to hear suggestions from this very knowledgeable group!
Hugs, Susan
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Sorry to hear that, Susan, although its very helpful to know that you consider Saci tolerable, it's so new & we don't even have a thread for it so not much info is out there
So, the Pfizer CDK2/4/6 trial could be very appealing, at least I'd look into it. Would it be with an anti-estrogen or by itself? Remember Frisky joined that trial in its early stage, but she dropped because she couldn't tolerate the combo and it depressed her- however shortly after that she said they did a major dose reduction for everybody on the trial. A benefit is that the compounds are very powerful, not only will you effectively block CDK2, but the CDK4,6 inhibition is also much stronger than either Ibrance or Verzenio. For me, I'm very interested in that drug, I bet it has strong single agent activity
I'm sure its profoundly worrying that treatments aren't lasting as long as before, but surely there are some effective immunotherapy combos heading our way and this trial might buy you some significant time until one comes along that really kicks the can waaaay down the road.
As always, we are very interested to follow what options you consider and choose!!
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Dear Susan, I am very sorry to hear that Saci might fail (I hope not). Whenever you have time and will to answer, I wanted to ask if you have a trop2 mutation that you were able to get Sacitizumab Govitecan (because I see you are ER/PR+)? Your MO could have a look at UCSF 500 profile in depth again and maybe there's something that could be addressed today - there are so many new drugs in clinical trials (trop2,b7-h3, etc.). Have you thought of new PD-L1 immunotherapies if you have this mutation? I am also utterly surprised they deny Enhertu because of SaciGov. I mean both of these drugs target completely different genes. This must be clarified too. All the best and keep us posted. Saulius
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hugs Susan. You are in a great place for access to other treatment options. I am sorry to hear this trial may not be working gir you but have high hopes there are several more out there for you.
Thinking of you
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hi!
What is the NCT number for the Pfizer CDK2/4/6 trial?
im always looking to put something in my bucket.Thanks
De
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So sorry Susan- I hope that it is not the end for Saci. I am also interested in the CDK2,4,6 - so hope that you will come back and tell us what your find out.
it is very disturbing that the effectiveness keeps getting shorter for each treatment- I heard a speaker who seemed to say when you add up all the treatments people get similar total treatment times (if very long on one treatment, lesser times on others) I don't know if that still holds true.
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Here is a link to the Pfizer CDK2/4/6 inhibitor trial. Interestingly, it is being tested with endocrine therapy for ER-positive patients, but without anti-hormonals for TNBC and ovarian cancer.the rationale here is that CDK2 activity can be high in cancers that are resistant to Ibrance, and/or in cancers with high c-Met, so its important to inhibit the CDK2 in order to get the CDK4,6 inhibitor to work
All patients had to have had 1-2 prior lines of chemo, and ER-positive patients had to have taken I/F or equivalent. Offered mostly at the heavy-hitters: UCSF, UCLA, MDAnderson, Memorial Sloan Kettering, Sarah Cannon in TN`...
my notes say its a pill and the CDK4/6 part of it is 100x stronger than ibrance, Frisky was on the highest dose used in early testing (100 mg) and had bad nausea, however they have since reduced the dose, so it would be interesting to know what level they are testing nowadays. The trial will run through 2023.
Anybody here on this trial?
https://clinicaltrials.gov/ct2/show/NCT03519178
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Cure-ious,
Thanks for posting that info about the trial. I tried to find it but was unsuccessful. I actually just wrote to Pfizer to find out if they are opening other sites any time soon. It's an interesting trial.
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The breast cancer arm of the PACT Pharma trial is unfortunately closed at all locations. Possibly opening up again in a few months
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Cure_ious: I don’t have an answer to your question regarding bromelain. I’m guessing it’s all a shot in the dark, and substances may have different effects on various tissues. And, sure, reducing inflammation may slow cancer growth but also potentially reduce response to immunotherapy. Let me know when someone figures it all out. In the meantime, if I had an FGFR mutation and couldn’t get either official FGFR blockers and/or immunotherapy, I would consider using supplements that inhibit FGFR in the hopes that that may enhance whichever chemo or targeted therapy I might be on, thereby possibly buying more time on that drug. But I have no idea how realistic that would be
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Nicole - there is a trial recruiting for berzosertib for breast cancer. https://clinicaltrials.gov/ct2/show/NCT04052555
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Thank you Moth...I am not going to be getting Radiation Therapy though? I was actually going to get TACE on my liver tumors...but maybe I could consider radiation I just don't know if I will be able to because they are near the colon wall....
Thank you for thinking of me.
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Luce...reducing inflammation can reduce effects of immunotherapy? Really? I am about to start LDN...and they say it can help with inflammation...because my itchy skin is out of control right now!!!>> so the dermatologist said to start the LDN again and see if it helps...but I want to be considered (if my MO says yes) for some Immunotherapy trials... thats also if she doesn't go the Verenzio/Faslodex/Affinitor route... She was talking Affinitor /Exemestane...
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Nicole,
Read that clinical trial -- I think it's for early stage, not metastatic. I only took a quick look.
Also, I would think that you could discontinue the LDN for any trial and be off of it for the same length of time as you are required to be off your other drugs prior to starting a trial?
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