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clinical trials

i was just wondering if anyone out 5ere has perhaps a good website in understanding clinical trials
alot of women I talkdont really u derstand the ins and outs
is there an advocate around that could help some of us understand them



  • Flowergirl
    Hello @maryk - you can try this site  - thanks @CurlyHair
    As each province is different as to what may be offered locally, you could discuss with your health care team about what is available.  There is some really good information at the above site and you can search by province. Hope this helps.
  • maryk
    Thank you Flower Girl 
    I hope the Caylex and avastin works 
    this on going dry hacking cough is getting to me
    whats your p,ands for. Ew Years eve?
    in gonna watch it on the tv
    my fav CNN Anderson cooper is ringing it in New York 
    Happy New Years!!!

  • Hi @maryk .  Welcome to OVdialogue.  @Flowergirl has suggested a great site for further information about clinical trials.  There are a couple of other resources you might like to look at too.  The Ovarian Cancer Canada website has some information and there is a relatively new site called It Starts with Me that is geared to patients and written in lay language to make the topic easy to understand.  Here are these 2 links:

    Another resource for help is the Ovarian Cancer Canada Regional Director in your area. Please feel free to reach out to them too for information and support.

     Here is the link where you can find that person based on where you live in Canada.

    On another note, when you use the "@" symbol in front of someone's name you tag them and then they are notified that someone has mentioned them in a post.  Otherwise, they might miss it.

    Hope you find this information helpful!
  • This is an old conversation, but one I think is worth continuing and here goes...

    I am looking ahead at potential clinical trials to share with my Dr so she can take them to the tumor board to see if they are appropriate for me. I am not sure when I will be participating, just waiting to see if my current drug cocktail is going to work and for how long. I do know that my next step is a clinical trial, hence my current research and many questions.

    My background (2019-present):
    Diagnosed via hysterectomy pathology 
    BRCA negative
    Platinum-resistant after two rounds of SOC followed by PARP-inhibitor maintenance (Niraparib: ZEJULA) (which did not work)
    2nd recurrence: Currently on Caelyx (PLD) and Avastin (Bevacizumab) (just finished the first cycle)
    London and/or Toronto are possible sites for participation in clinical trials

    Potential trials:
    • NEMVALEUKIN Alfa + Pembrolizumab (Phase 3) 
    • Pembrolizumab/Placebo plus Paclitaxel with/without Bevacizumab (Phase 3)
    • Batiraxcept/Placebo in combination with Paclitaxel (Phase 3)
    • Alpelisib plus Olaparib with no BRCA mutation (Phase 3)
    • Using Genetic Profile to Determine Treatment for Patients who previously received PARP-inhibitor (Phase 2)
    • Immunotherapy Platform Study (IPROC) (Phase 2)
    • Maintenance treatment with Bevacizumab and Atexolizumab (Phase 2)
    Has anyone reviewed/considered any of the above trials and/or spoken to their oncologist about them? If considered but did not follow through, why?

    Does anyone have experience with biopsies? (I've never had one)

    Some of these trials require confirmation of certain gene mutations or expressions...I have no idea about how that would be determined - probably thru biopsy or bloodwork - will discuss with Dr if considering one that requires further determination.

    If you have participated in any trial, what did you find to be the most difficult part of the commitment for you? (travel, time, side effects, waiting, not knowing if placebo or not, follow-up commitment, etc.)?

    Has anyone discontinued their participation in a trial? Why? If you withdrew from a study, did you go back to chemo? Did you consider another study?

    What happens after trial completion? I have seen some roll-over studies for continuation if the drugs have been successful. But I don't know if that is true for all, the majority, or some. I have also heard that, where successful but no roll-over study is available, it may be possible to find out which drug you were receiving. I imagine that would not be easy to find out and maybe impossible in some cases. Does anyone have any experience or thoughts on this? Do they just stop treatment, even if it has proven to be successful?

    I think any feedback regarding your experience with a clinical trial would be welcome by many of us who are just at the stage of our journey where we are now considering "what next?" 

  • Strongwoman
      So many questions and looks like a wide array of trials. I, sadly, can't answer most of your questions but perhaps other ladies may have some input based on any trials they have been on.
      I will say, that although you are questioning or believe feel you haven't had a biopsy, your tissue from your hysterectomy would be used (the diseased part). That is how they would come up with the pathology and diagnosis as to specific type and what they call histology.
     My determination for the trial drug was approved by London requesting a piece of my tissue from Hamilton to do their own testing etc. There is usually a document to sign for release by you if the tissue is at a different institute than where the trial or alternate oncologist resides. 
      Does that help clear up that part of it?  Also, if you do go to a new institute for medical care, although they may have a history of your case I have found they usually like to do their own bloodwork the day of your appt with them.
     Hope that helps and keep us posted 
  • @Strongwoman
    Ok. That makes sense and definitely helps with the pathology part. Thanks!

    Good to know about blood work too. I just had a port implanted yesterday and am hoping that will come in handy when I do head to a trial. I know only nurses can do the port needle stuff so it will depend on who is doing the draw. I still have to get vein draws at my Dr clinic appts. I’m sure I’ll appreciate the port even if it’s only used for infusions. My veins are a challenge!

    I have a CT at end of Feb that will determine the direction I’m headed. I’m hoping drugs working and I can wait on the trials for a bit. I try to listen to my body but this round I’m getting mixed messages. Some days I would swear the drugs are working, yet other days my body sends me a message and I think “oh oh, what was that?” I’ve also read that it can take 2-3 cycles for these drugs to start working…so just waiting. 
  • mjmck21
    Adding my experience with clinical trials here as well. In other discussions I wrote how I had recurred very quickly last year. Merely a few months after my last chemo and an optimal cyto reductive surgery. (they got everything they could see so at the time there was some hope that I would have some disease free time possibly years) Before I began treatment again, this time Taxol and Avastin, my oncologist in Hamilton referred me to Princess Margaret for possible clinical trials. Bio Diva and one testing an immune therapy drug currently used in lung cancer Durvalumab. I needed to have one of two possible tumor markers for this. Unfortunately I do not have either so am excluded from this trial. Bio Div does not provide treatment but they test for over 500 tumor markers. This could be very useful for deciding future treatments that are in the pipeline or at the very least provide the research community with data to treat future generations. Unfortunately I have only 1 marker out of 500. TP53 which I understand is very typical for HGOC so nothing they can use and this is very disappointing. I'm doing well on Taxol/Avastin for now but the real advances across cancer sites seem to be in immunotherapy so wishing I had more to work with. 
  • GloHo
    An oncologist in my local centre is actually conducting the BioDiva biomarker study, so it's on my list for discussion. I didn't realize the number of biomarkers they test! I also have an immunotherapy trial for discussion. This is my first meeting with the medical oncologist...I hope they are ready for me. I've done lots of research and have MANY questions about next steps. 

    I am on my second recurrence and I'm just finding it hard because every time I try a new treatment that doesn't work, my CA125 goes up and the CT scan shows new and progression (there were some decreases though, too). Anyway, as far as I know, I still have options and I'm holding onto that to keep my positivity up.

    Glad to hear that Taxol/Avastin is working for you. That's a nice place to be in. 

    Thanks for taking the time to add to this discussion. I truly appreciate any and all information related to this topic.
  • mjmck21
    Thanks @GloHo clinical trials really are a bit of a puzzle, not easily deciphered and we obtain bits of information from here and there. Bio Diva is so far ..I think the most comprehensive way to have our biomarkers tested and I wish you the best results in that they find some. I'm hoping there are still some trials that don't rely on markers for inclusion but some other criteria and I will focus on those. I'm thinking that list will expand as well as they identify other markers. If I learn anything else I will be sure to post. Let us know how things go for you.
  • GloHo
    Hi. I have an update. Met the entire clinical trial care team at my appointment on Monday (Dr., nurse, nurse practitioner, and trial coordinator). I am in the pre-screening process for the ARTISTRY-7 trial [Nemvaleukin Alfa + Pembrolizumab (Phase 3)]. My biopsy has already been scheduled for Friday. They are testing for PD-1. The results will not affect my eligibility...they are collecting as part of their research database. Just awaiting a CT appointment which also has to be done before the trial begins. Once that appointment is set, I believe I will be able to start the program in 2 weeks, if accepted. There were no red flags in my file, so I am hopeful that it will be a go. The trial consists of 6 drugs: 2 trial drugs (Nemvaleukin Alfa & Pembrolizumab (Phase 3)) and 4 standard of care drugs for platinum-resistant ovarian/fallopian tube/primary peritoneal cancer (PLD, paclitaxel, topotecan, gemcitabine). No placebo! The groups are: both trial drugs, one trial drug alone, or one of the four standard drugs. So win-win...I will be getting something specific to my cancer. I will be advised which drug treatment I will be receiving prior to the start of the trial (not a blind study). They sent me home with the Study Information and Consent Form (24 pages) to review and ask questions prior to signing. 

    I am also in the process of providing consent for two other studies for research purposes only.
    POWER (study collaboration Western University, Lawson Health Research Institute, and London Health Sciences). This study tests for the more common cancer markers specific to ovarian (for me). I have already heard from this study coordinator and the paperwork is done. Once the tissue is sent for testing, it will take 6-8 weeks for results.
    BIO DIVA is being conducted by an oncologist in my cancer centre. As you know, this is an extensive testing study. I expect to hear from the coordinator today to get the paperwork done. 
    Both studies will grab tissue samples from my biopsy this Friday. 

    I found it interesting that the trial coordinator will actually be at the biopsy, the sample(s) will be handed directly to her and she will send it immediately for the main study PD-1 testing. 

    The medical oncologist has also set up a telephone appointment with me on Thursday (the day before the biopsy). No reason was given, but I imagine it may just be to confirm that I do want to participate and to cover any questions or concerns I may have. 

    I am not sure if all trial application/prescreening/appointment processes are this efficient, but this Cancer Centre never ceases to amaze me. 

    Thanks for keeping this conversation going. Sorry this is so long, I know you are familiar with a lot of this. When I searched in January, the last post was from 2018 - way outdated. So I decided to try to bring it to the forefront again to get more up-to-date info on processes and current trials. I wasn't expecting to be adding information about trials myself so soon! I hope it is helpful to others who may be thinking about clinical trials as part of their journeys. I will continue to update as I move through the trial process. 

  • mjmck21
    @GloHo this is exciting. I'm very pleased for you and I  am also going to look into this study as they appear to be recruiting from Hamilton according to the CT site. Thank you for keeping this going!!!
  • GloHo
    Good luck to you!! 🤞 Keep us posted.
  • hope2022
    Good morning,

    I have been reading your discussion about clinical trials as I am currently searching for one myself. 
    How do get tested for biomarkers? Is it just a blood test? I am a little unsure on that and have not asked my oncologist about it yet. Any information you can give me would be really helpful. 
    Best of luck to both of you... with Bev & Taxol and clinical trial. Sending you positive vibes!

  • GloHo

    Hi Hope.

    First, if you are not yet connected with a medical oncologist at your cancer centre, I would suggest you set up a consultation appointment with them. You can do this through the surgical oncologist you are seeing.

    My trials are all Ontario-based. I'm not sure what province you reside in, there may be something available in other provinces. You can check this site: Fill in the appropriate search criteria for you (and be sure to check the "Recruiting/Not Yet Recruiting" circle). I prefer not to fill in too much criteria because it narrows the search too much. Under "Advanced Criteria," you can type in your city or province in the "Location Terms" box. 

    The biomarker studies I am involved in are drugs are involved. 

    The following is the BioDiva study which is being conducted in several sites across Ontario:

    The other study is POWER. This study is not advertised and is being conducted in London only. I became a part of it because that is my Cancer Centre and my medical oncologist invited me to participate.

    The drug trial I am going to be participating in is ARTISTRY-7. It is being conducted in three sites in Ontario and one site in Quebec. This trial has no placebo, so no matter which drug is randomized, it will be something specific for me (the trial drugs are immunotherapy and the other drugs are standard-of-care).

    I just switched over to the medical oncologist in my centre to start the trial process and although my surgical oncologist was knowledgeable, the medical oncologist has more in-depth knowledge of what trials and studies are available and which ones would be best for me. I did my own research before I spoke to the medical oncologist and the trial she suggested was number one on my list! I just felt better having a couple of options in my pocket for discussion purposes...why is that one better than this one for me, etc.

    If you have any other questions, let me know.

    Hope this helps. 
  • hope2022
    Thank you so much for responding quickly. I really appreciate you taking the time to do that. 
    I am at the BCCA in Vancouver. I do have a medical oncologist here and and she has been looking for studies for me. Currently there is nothing here in BC that I am eligible for, so I am looking at trials outside of the province that might be an option for me. I am aware of the ARTISTRY-7 study that you mention. I saw your post last Thursday about getting a biopsy for the trial. I have been told that there is no safe way to get a needle in for a biopsy because of where the cancer is. That's a hard one to wrap my head around and have wondered if getting a second opinion is something I should do. I see there are some studies that will accept archival tumor tissue, but there doesn't seem to be too many of those. I'm not giving up hope, that's for sure...

    I was on taxol /avastin until it stopped working at the end of March and currently taking Gemcitibine weekly. My ca125 went up after the first cycle and with the rumblings in my stomach I suspect it may not be working. I started the second cylce last week, so will see what the next few weeks bring. 

    Sorry, I didn't quite understand the information about bio markers. Is it only something that you get tested for if there is a study you are eligible for? I feel I should know this by now, but I don't. I have had 2 sets of genetic testing done in the last 5 years and nothing came up. 

    I hope this all makes sense, I feel like I have been babbling a bit.

    Thank you again.
    Take care

  • GloHo

    Babbling allowed...actually encouraged! Since my brain is scrambled right now with everything that is going on anyway, I totally understand everything you've said. 😊

    I am sorry to hear that your cancer precludes you from having a fresh biopsy done...but I think that could happen to any of us at any time during our journey. I only had a fresh biopsy because it was quicker than waiting for pathology to confirm whether or not there was sufficient stored tumor tissue for testing and then waiting for them to transfer it for the trial. This allowed for an earlier start date for the trial. It also allowed for multiple cores to be collected for the other studies I am involved in. Although the other studies would also have gone through the stored tissue sample process if I wasn't getting this fresh biopsy. The biopsy was ultrasound-guided, they did have a discussion on how tight it was for them to get a sample and they chose one side (left) over the other (right) for that reason. I would ask if an ultrasound would help determine the viability of a biopsy. I know CT scans show a lot, but maybe an up-close look with an ultrasound might show a potential line of access. It might be worth discussing this with your oncologist. I would probably also get a second opinion to satisfy myself that I have explored every avenue fully.

    BioDiva does accept stored tissue samples. There is something in the fine print that states a biopsy will not be performed if the study doctor determines it is unsafe. So, maybe they will accept the stored tissue samples for the purpose of this study. Worth asking about. The study also requires blood samples...give, give, give! As well as Ascites Collection and other fluids. I have no fluid samples, but if I ever have to undergo any procedures related to fluids or other "things" (bowel, bladder, liver, kidney, etc.), a sample will be collected for study purposes.

    (I have sent you a personal message - check your profile page for messages)

    My experience with biomarker testing has also been limited. I was tested for BRCA to inform whether I received Olaparib or Naraparib for maintenance treatment. I am currently being tested for PD1/PD-L1 for the trial. So, it does seem that biomarker testing is specific to the drug treatment that you are eligible for and being considered for. 

    I am fortunate to be able to participate in the biomarker studies due to my location. These are of great interest due to the fact that they test a vast array of genes, proteins, and other substances unique to me/my cancer. And...the results are shared with my oncologist which could potentially lead to targeted therapy (if available) for any markers found.

    In a perfect world, anyone diagnosed with any cancer should be tested for biomarkers at the beginning of their journey. Although that raises more questions...Do biomarkers change during the different stages of the disease? Is it better to get biomarker testing at the beginning or at another point in time? I am sure budgetary restrictions are the determining factor in all of this!

  • hope2022
    That is interesting about the ultrasound-guided biopsy...I will add that to my list of questions when I see my doctor on May 23rd. 
    Thank you, now I have a better understanding of the bio-markers and Bio Diva study. 
    They did test my tumor tissue from 2018 surgery for mis/match was normal. I also had an onco-panel done thru BCCA and as I mentioned genetic testing in 2018 and 2022. Lots more genes tested in 2022 - bloodwork was sent to the US.
    Maybe I have covered all the bases - it's all so complicated! 
    I agree, it does come to money here in Canada. 
    I hope you have recovered from you biopsy last week. It must have been painful. 
    It sounds like you have really done your homework and are on top of things.
    Time to get ready for chemo appt this afternoon. It's a beautiful day here in Vancouver, so nice to see the sun shining !
    Take care
  • GloHo
    It sounds like you may have covered all the bases as far as genetic/biomarker testing is concerned. 

    The biopsy procedure was was just a few days this week that I felt some discomfort at the site. My GP says it's normal and I'll discuss with my oncologist on Thursday. But the discomfort has subsided, so I'm thinking all is ok.

    I have an ECG after my oncologist appointment on Thursday and CT on Friday...all for the trial. 

    Enjoy the sunshine. We're still dreary (gray and raining) here. 

    Hope your chemo goes well.

  • mjmck21
    mjmck21 Legacy
    @hope2022 apologies for the delayed response.  But @GloHo has provided all the details I have and more. I was tested for 19 genetic markers (blood draw) at diagnosis which I assume is the same across the country and Bio Diva (500+ markers) used my archival tumor tissue. I also paid over $2600 to have an HRD test (also archival) done in the US. It was negative. I wanted to know how likely the PARP Inhibitors would work for me and while the cost was steep it seemed like a good step at the time. I was tested for two other markers BA3011, BA3021 for an immunotherapy trial at Princess Margaret and was not so excluded from this trial.  I may have mentioned this but after all of this I am only positive for TP53, which I understand is true for everyone. I do feel further adrift in that all of the advances made in OC research and targeted therapy seem to rely on having various mutations and they have not found any so it is less hopeful. But in the end it is important to know our status and pursue and clinical options. 
  • Fearless_Moderator
    @GloHorThanks for your updates.  I find it surprising how often we hear about particular studies or reseach progress through our own network and not through our own cancer care teams unless we ask.  Like @mjmck21 I"ll also be asking my team if the study applies to me (most likely) and managed within a reasonable commute for me to participate.  
  • hope2022
    Absolutely no apologies for delayed response. As you see, mine are often that way as well...
    Thank you for all your input in this discussion. I have a better understanding now about bio markers. Sorry to hear that you weren't eligible for the immunotherapy study at PMH. I too was positive for P53 and also WT1(wilms tumour). Nothing else has come up after all the testing I've had done. 

    I continue my search and try to stay hopeful that something is just around the corner, but hear what you are saying about so many trials being dependent on expressing a certain protein, gene etc. I agree, knowing our status is so important in this journey. 

    This discussion has been helpful, and I have learned a lot from it. 
    Thanks again

  • GloHo

    I have been randomized into the main study group in Artistry-7! Yes! Nemvaleukin Alfa + Pembrolizumab (Keytruda). I am so looking forward to trying this immunotherapy treatment.

    Pre-screening included oncologist visits, ECG, CT, multiple blood draws, and a biopsy [tissue required for PD-L1 testing (if adequate sample in pathology, that can be requested rather than a fresh biopsy), and the result does not exclude from the trial]. I had never had a biopsy (this one was ultrasound-guided), so wasn't sure what to expect. The procedure was quick and painless. I had a little discomfort for a few days the following week (felt like muscle), but it resolved itself. 

    The time commitment for the trial is significant. It is a 21-day cycle with one week on treatment and two weeks off. On days 1-5, I will receive Nemvaleukin Alfa. On day 1, I will also receive Pembrolizumab. Each day will require approximately 6-8 hours at the hospital. The days start at either 7:30 or 8:30 am. The order of the day is oncologist, blood (via vein), one hour of observation (vitals, waiting for drugs), blood [specifically for trial purposes (via port)], treatment, blood (via vein), ending with two hours of observation. There will also be blood drawn each Monday on the off weeks and I will be scheduled for CTs every 3 weeks. If nothing else, the oversight is tight and I welcome the attention to how I am responding to treatment more frequently than standard of care.

    The most common side effects are chills, nausea, and fatigue. Of course, decreased blood counts (neutrophils, platelets, etc.) will also be monitored and treatment will be adjusted accordingly, if necessary.

    I have spoken to my oncologist about all of the "what ifs" that could arise and am satisfied that I will know what to do if something does happen.

    The other concern I raised with my care team is the fact that London does not do Heparin locks on ports. I have heard one person who has been having some difficulty related to this, so I will wait and see. I will also ask the chemo nurses when I go for treatment to see what the bigger picture is on this issue.

    Now I am trying to plan my week with the long stays at the hospital. Books, puzzle books, and my cell phone should keep me busy for a few hours. I'm hoping I will be able to sleep some of the time. I am also trying to figure out what I should take to eat. During my last treatment, I was not hungry at all. So, I will take a little bit of the things I like and see how it goes in the first few days. 

    I begin treatment next week and will keep this post updated throughout my journey.

    Biomarker studies update: Tissue and blood samples have been sent for testing for the POWER study. The BIODIVA study has collected the blood they need and is just waiting for my tissue samples from pathology, then that will be sent off too.

    Even though this information is specific to Artistry-7, it may help other Teal Sisters who are considering participating in a trial by raising questions, opening other avenues of exploration, and informing their decisions. Remember, everyone is unique in their own way and each of our experiences will not be the same. 
  • hope2022
    That is wonderful news ! I am so happy for you. Glad your pre-screening went well and it sounds like you are all ready to go for Monday. 

    It definitely is a big commitment, but one that I'm sure most of us on this journey would be happy to make. You may be surprised at how fast the day goes between, reading, naps and a little cell phone time!

    Good luck on Monday...will be thinking of you.
    Take care

  • Strongwoman
    Strongwoman Moderator
      What an amazing update and your excitement about it all comes through I'm your post. Thank you so much for sharing and for wanting to continue to share along this new avenue of treatment, I am positive quite a few Teal Sisters will be following along. The may also choose to base some of their own decisions around trials in general or Artistry-7 specifically.
     Your days in treatment sound lengthy and you are planning well. May I suggest audiobooks or podcasts and/or I have an app that is colour by number that I do from time to time. I sometimes took my knitting to my chemo days as they were usually lengthy like yours will be.  As for food to take, I brought protein shake, fruit, granola bars, yogurt with chia seeds and frozen berries (helps keep it cold) crackers/cheese on my visits. The hospital did provide food at lunch when I went but I didn't care for it. Not sure if anything on that list will help you at all but there in case it does. I took ginger chews as well. 
      Sounds like side effects may be minimal on the grand scheme and do NOT mean to diminish any side effects as they can be all consuming when occurring.
      Thank you again for the detail of your post and info. @hope2022 said it well and wish you well on your journey.
     Take care ladies and look forward to updated posts.

  • Fearless_Moderator
    @hope2022 congratulations on being approved for the trial.  I hope it's successful for you.  And thank you for the excellent update. If you could continue to share your experience for others here that would be wonderful.  
  • GloHo

    Artistry-7 Trial update!

    Cycle 1 

    Week 1

    Day 1 (Monday): blood (via vein), oncologist appointment, pre-treatment meds, one-hour observation, blood (via port, trial only), treatment (Nemvaleukin Alfa+ Pembrolizumab), post-treatment blood (via vein, trial only), and two-hour observation.

    I only have to see the oncologist for a check-up and drug approval on the first day of each cycle. With this being a new trial for everyone involved, the chemo nurses were being extra cautious to ensure they were following trial protocol and procedure every step of the way. The trial coordinator was on hand to answer questions and, if needed, either my oncologist or the lead trial oncologist were also available. This turned out to be a very long day. 

    My downfall on Day 1 was not related to the drug infusion, but rather the two Benadryl I was given for pre-treatment. I was slurring my words in less than an hour and I was in and out of that haze until 9:30 the next morning! 

    The infusion side effects included some cramping in my abdomen that only lasted a few minutes on the way home, some chills when I got home, loss of appetite, and some achiness throughout my whole body. Since I was in my Benadryl haze, I really don't know the extent of the side effects because I slept through them! When I briefly woke up that evening, the side effects were gone. 

    Day 2 (Tuesday): blood (via vein), pre-treatment meds, one-hour observation, blood (via port, trial only), treatment (Nemvaleukin only), blood (via vein, trial only), and two-hour observation.

    I advocated for a reduced dose of Benadryl! The chemo nurse suggested rather than reducing the dose of Benadryl, that she could give me a full dose of a replacement antihistamine. Because this is a trial, there was back-and-forth with the trial coordinator and oncologist to determine if the pre-treatment meds could be altered without going outside of the trial parameters. It was allowed, so I chose the full dose of the replacement antihistamine. What a difference! I still slept a bit, but I was not totally out of it!

    The infusion side effects included some chills, achiness, and a mild headache when I got home. I took Tylenol. Still not much of an appetite, but I was able to eat a little bit of my homemade vegetable soup. Then I took a nap and was feeling much better throughout the evening. The chills and achiness returned later that evening, so I took another Tylenol before I went to bed.

    Day 3 (Wednesday): blood (via vein), no treatment

    I felt physically and mentally strong. I was in a positive mood and was ready to get another treatment. However, my blood counts were not cooperating - my treatment was put on hold due to my liver enzymes skyrocketing! This basically happened in one day. So very thankful that the strict blood work protocol is in place. Oddly, I was not discouraged by the hold. I was expecting something to go wonky (usually my neutrophils and platelets), and I figured the trial would have some built-in options for this type of scenario. The trial coordinator had to contact the trial board to report this development and find out what the next step should be. She would then discuss this with my oncologist and the lead trial oncologist to determine what would be best for me.

    Day 4 (Thursday): blood (via vein), no treatment, oncologist appointment

    I met with my oncologist to follow up with the hold, review my blood work, and discuss the move forward. My blood work showed a significant decrease in my liver enzymes, still not down to normal, but close. Out of caution, it was decided that the trial drug (Nemvaleukin Alfa) would be given at a reduced dose starting Cycle 2 and the other drug (Pembrolizumab) would be given at the normal dose.

    After this appointment, I did a thorough review of my blood work and noticed that my neutrophil count had decreased significantly - but still within the safe zone. 

    Week 2

    Tuesday: blood (via vein), oncologist appointment

    The achiness side-effect returned one week after treatment. It lasted for about 3 days.

    I met with the trial oncologist to review my blood work and discuss in further detail the options that would be available given some different scenarios that I posed to him.

    Again, my liver enzymes decreased (another sigh of relief). However, my neutrophil count had increased significantly. He confirmed the decreased dosage of the trial drug beginning Cycle 2. The increase in neutrophils could be a result of the drugs doing their thing. We will take another look after next week's blood draw to see where things are at. 

    The trial options start with a reduced dose of the trial drug. If my body reacts to the reduced dose, then the trial drug will be stopped but I will continue with the other drug, also immunotherapy, for as long as possible.

    Week 3

    No side effects this week...just some fatigue (it doesn't seem to be as bad this week).

    Monday: blood (via vein, trial only)

    Thursday: blood (via vein), oncologist appointment

    My oncologist scheduled this appointment because she is going to be away at the beginning of Cycle 2 and wants to keep on top of my blood work and how I am feeling. This week would normally have a trial-only blood draw. 

    My blood counts were all back to normal. My oncologist gave the go ahead to move forward with the reduced dose of Nemvaleukin Alfa starting Cycle 2. This blood draw showed that my CA125 has increased significantly.

    Other comments
    I have noticed a slight increase in fatigue and require a nap each day. Not out of the norm for any treatment regimen. So...adjust my daily expectations and routine and get on with it.

    I also noticed that my LD blood count decreased slightly. It has been steadily climbing as my disease progressed. I know I am reaching with this one but, for me, this could be a positive! 

    It is my understanding that immunotherapy works differently than regular chemo and that it may take 2-3 cylcles to determine if the drug is working. So, the rise in my CA125, although alarming to me, is not a surprise.

    I will be getting a CT scan every six weeks during treatment to determine the effectiveness of the drugs.

    The blood drawn for trial only, is sent away for testing and the results do not appear in my health records (ConnectMyHealth). The trial coordinator can share the results with me, if I request it. The first vein blood draws on treatment days are duplicated on Days 1, 3 and 5 for my oncologist's review.

    The three hours for observation embedded in the trial schedule make for very long days.

    The checks and balances built into the trial seem a bit daunting, but are necessary for trial purposes. It's all for research! Not only to help myself get through this, but to inform decisions for others that follow.

    I am hopeful that Cycle 2, starting June 5, will be more successful and less eventful so that I can shorten my updates!! 
  • Fearless_Moderator
    @GloHo thanks so much for these updates.  They are so helpful to our community and those who've never experienced a clinical trial.  Although each trial can be quite different in purpose and administration what seems consistent from my own experience is the well controlled surveillance.   

    Keep us posted and good luck.  
  • GloHo

    Thank you so much for the comment.

    Just to reiterate for those who have an interest...

    Yes, it is true that each trial is different AND each person's experience throughout the trial will be unique. There are so many variables that will affect the response of each individual. There are two of us at my cancer clinic on the same drugs...and we have totally different responses! The side effects are similar, but I have the added complication of my blood work being wonky. The trial parameters allow for different scenarios and grades of adverse reactions to assist with the move-forward decisions that I have had to consider as a result of my reaction to the drugs.

    Artistry-7 is a trial that is currently open and I want to provide an overview of my experience throughout the trial...something fulsome and current. 

    I did a lot of research ( was my main source of info) before I made my decision and I would recommend the same to anyone interested in participating in a trial. The more you review the trials available, the more knowledgeable you will become and will be able to speak to your oncologist from an informed position. Your oncologist will work with you to determine the best trial for you. Self-advocate and don't be afraid to ask questions...why do you think this is/is not the right trial for me?, what if (scenario) happens?, can I be tested to see if I have the biomarker required to participate?, will I require a fresh biopsy or are there samples in pathology that can be used?, when will I know which trial group I have been selected for?, when will I begin the trial?, etc. If you are able to travel to a different site for a trial, be sure to mention that as well (the trial timetable will help you determine if travel is feasible for you). 

    Note that there are trials available at all stages of our disease, it is never too early to start researching to see what is available and when. It may also help with decisions you are making throughout your journey. A certain path or new drug regimen may qualify you for a clinical trial in the future. Ask your oncologist at every visit or two whether or not there are any new trials available. 

    I do hope that my updates as I move through this trial will be informative and helpful to others. 
  • GloHo

    Artistry-7 Trial update!

    Cycle 2 

    Week 1

    Day 1-2 (Monday & Tuesday): Received reduced dose of Nemvaleukin Alfa  + regular dose of Pembrolizumab. Received alternative antihistamine. 

    The infusion side effects included some chills and a little achiness when I got home. Although I am receiving an alternative antihistamine, they are still a bit sedating, so sleep on and off throughout the evening. 

    Day 3 (Wednesday): Bloodwork showed a slight rise in liver enzymes, but not at a level that would affect the continuation of treatment.

    The infusion side effects included chills and achiness. I was not as tired today, so was able to eat, drink and stay awake most of the evening. 

    Day 4 (Thursday): Treatment continued. The side effects were the same.

    Day 5 (Friday): Bloodwork showed another rise in liver enzymes, but not at a level that would affect the continuation of treatment; however, my neutrophils fell to a level that was unsafe to receive treatment. So, no treatment Day 5.

    Week 2

    Tuesday: blood (via vein) for trial 

    Blood work showed that my liver enzymes decreased and the neutrophils increased, bringing both to the normal range.

    No side effects this week...just some fatigue.

    Week 3

    Monday: blood (via vein) for trial

    Did not call for results because everything was in the normal range last week.

    No side effects this week...just some fatigue.

    Other comments

    If not for the decrease in neutrophils, I would have been able to complete the full 5 days of treatment.

    The reduction of the trial drug seems to be better on my system. Still an increase in liver enzymes, but not alarming.

    I have an appointment with my oncologist on Day 1 of Cycle 3.  We will discuss options to keep my neutrophil count up.

    I have a CT scan scheduled following my Cycle 3 treatment week. So, we'll see what that shows.

  • @GloHo
    Thank you for the updates on your trial... there is certainly a lot involved for your trial and it doesn't sound like an easy road, but hopeful for sure!  I saw your post last Thursday and know you are waiting for CT results. I know how much anxiety comes along with waiting, we've all been there before... fingers crossed for a good outcome for you! 

    I have not been joining the chat on Thursday's as I am still receiving Gemcitibine and it's been on Thursday. My ca125 went up in April, down in May and up again in June. The ct scan in mid June showed cancer stable and slight shrinkage with largest tumour. I'll see what happens at the end of July.. confusing or what?? 

    Still looking at clinical trials of course, and there are 2 options.. both phase 1/1b. My understanding is that there is a small chance of success with early trials, so not sure if it would be worth it. 

    I had genome sequencing done, to see if there was possibly an option for private pay targeted therapy. Unfortunately, nothing much came out of it. I am HRD positive. 

    With your bio diva study, did they look at your MSI and TMB status (microsatellite instability and tumour mutational burden)

    It's all so complicated, that's for sure!!

    Best of luck with your ct results!