OVdialogue – consider joining our team in the role of Peer Support Volunteer. Over a few hours each week, you would be part of a team that helps connect people, support conversations and are thought leaders for OVdialogue. This is your opportunity to give back to those who have/continue to support you through the tough times, share your unique experiences, and help celebrate successes. For more details of what this entails, please reach out to @Mfallis (mfallis@ovariancanada.org).
clinical trials
Comments
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Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
Unfortunately, this is the end of my journey on this trial.
Cycle 8
Week 1 Days 1-5
Treatment: Received treatment for the entire cycle, Days 1-5.
Blood work: My liver enzymes are still a bit elevated and my neutrophils did not drop as much as in previous cycles. Day 5 treatment was approved and received.
Side effects: Chills (manageable), aches (manageable), fatigue (decreased during week)
CA125: Increased slightly.
CT scan: This CT scan reports “slight progression.” However, it is a matter of interpretation and what my oncologist sees is much different. There is definite progression and I have been removed from the trial because the drugs are not working. This is supported by a rise in my CA125 over the last two tests and minimal progression in a previous CT. From what I read and tried to interpret from the report myself, I concur with my oncologist.
Next steps
I will begin weekly paclitaxel in a couple of weeks.
There are currently no Phase 2 or Phase 3 trials available for me at this time. My oncologist has reached out to see if there are any Phase 1 trials that may be appropriate for me.
My thoughts
I am exploring combination drug treatment options for the last three standard-of-care treatments available to me (weekly Paclitaxel, Gemcitabine, Topotecan).
I had some reservations about continuing with my current oncologist now that the trial has been discontinued, but she has proven to be attentive, patient and emailed several contacts regarding potential trials while I was still on the phone with her. I still have some reservations, but I am going to give her a chance. I also know she is very agreeable to me getting a second opinion if I feel it necessary.
I hope this journalling of my experience in this trial is helpful to others considering participating in one, both now and in the future.0 -
So, I have been busy trying to find a trial I am eligible for. Unfortunately, there are no trials available for me at this time (including Phase 1).
I found one trial that I followed up on. On the surface, it was very clear that I did not meet the # of trials criteria - I had had too many lines of treatment. However, I have reviewed so many different trials and each has its own unique set of inclusion/exclusion criteria AND exclusions to those rules, that I felt it was worth clarifying my interpretation of the criteria for this particular trial. Basically, I was not sure if a clinical trial was considered a “systemic” line of treatment. After all, the drugs are not approved for systemic use, so maybe that treatment would not part of the equation. Plus, I had read in another trial that clinical trials were excluded from the # of treatment criteria. Unfortunately, for this trial, the clinical trial was included as a line of treatment, so I was deemed ineligible for participation.
As a result of this latest search, I want to be sure that anyone looking at trials not be too quick to exclude themselves. As mentioned above, all trials are unique and do not follow the same inclusion/exclusion criteria. Some trial criteria are very clear, while others leave room for interpretation. So, if you are not certain…ALWAYS ASK.If you ask and your oncologist interprets the criteria in the same way you do, give a little push and ask your oncologist to contact the trial Dr for confirmation. The other option is for you to contact the trial contact directly with your specific question. In my case, the trial contact directed me to work through my oncologist to get the information clarified. My oncologist made the call and my ineligibility was confirmed.Good luck on your search!!0 -
Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
End of Trial Follow-up 1
The Artistry-7 trial protocol required lots of bloodwork, a urine sample, and an ECG for end-of-trial data. There will be another follow-up in the next few months.
The BIODIVA study also wanted lots of bloodwork because my treatment is changing.
The bloodwork draw was done in order of priority...Oncologist bloodwork, then trial, then BIODIVA. Because they were doing a vein draw for blood, and even though they had to poke two veins to get more blood, they could not complete all of the vials for BIODIVA, but they were okay with that.
CANNABIS SURVEY: The lead oncologist for BIODIVA is involved in a survey regarding cannabis use and I was asked if I would be interested in doing a Cannabis survey. Of course I am! This is not connected to the BIODIVA study, it is its own separate study. I will do the survey in the next couple of days. After researching a few articles on CBD for ovarian cancer, I am very interested in seeing where this will lead. I am also wondering if I have found an oncologist who is willing to investigate/consider the use of turkey tail mushroom therapy. I mentioned it to the coordinator who thanked me for the info and indicated that was exactly the type of information they are looking for from patients...they welcome the opportunity to explore/consider alternatives. I don't know why I was approached at this time, but it makes me wonder why this survey is not available to all ovarian cancer patients no matter where they are in the treatment process. It is an optional survey, so patients can decide whether or not they are interested in doing it. I know that in a lot of surveys if someone is not interested, they will not complete the survey. This is unfortunate because it is important for studies to know not only why some patients are interested but also why some are not and, perhaps, how many are indecisive and why.
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A clinical trial about clinical trials 😁
If anyone is considering participating in a clinical trial and want an opportunity to input your personal experience on a trial - check this out.Appraising Medical Trial Experiences of Cancer Patients
NCT05801795
NOT YET RECRUITING - Expected start date is April 20240 -
Correction to title above
Appraising Medical Trial Experiences of Ovarian Cancer Patients
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@GloHo I checked it out but didn't find much info and/or links to follow it further...perhaps I am missing something? Quite possible as the way it goes some days. I did find this which I found interesting......
"Analyzing Factors of Patient Involvement in Ovarian Cancer Clinical Trials"
So they are doing a study on patient involvement in OCC trials? Interesting....wouldn't they have that data already? I am confused.
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@Strongwoman
I believe these are both for information gathering purposes (online) from people going through the clinical trial process starting from the beginning of a participant’s decision to enrol. To see what works and what doesn’t. What roadblocks are. What is good/not good about processes, etc. There is still a lot of apprehension around clinical trials and I don’t think participation is as good as they would like or need to get fulsome data for some of these trials.Does that make sense?0 -
@GloHo It absolutely makes sense. I know when I was looking, I was like do I qualify, do I not? Am I one of those in between ones and a maybe? I feel that this is great that they would take the time to see the perspective as a patient and want to attempt to iron out any kinks in it. I know some also look at doctor reviews which we all know cannot be trusted. A lot of the time it is mostly negative and rarely do you find positive ones online. That could also be a roadblock to some trials. I think location and time it consumes is another concern for patients. For example, do they have someone that can take them/pick them up and what is the time commitment etc. It's wonderful. I will be very interested to see the results from this and what they will end up doing proactively to possibly fix the roadblocks being encountered. Thanks for sharing!
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Phase 1/2 Study of 23ME-00610 in patients with Advanced Solid Malignancies
Princess Margaret Hospital
My Cancer Type: High-Grade Serous Ovarian Cancer (Note: In this trial, they are exploring the effects of this drug on several cancers, not just ovarian).
Part A (Phase 1) - Complete
- dose escalation phase
- determine maximum tolerated dose
- recommended phase 2 dose selected
Part B (Phase 2) - Currently enrolling participants
- dose expansion phase
- patients receive recommended dose
Process
- Primary Onc submits request to PMH
- PMH reviews and sets up pre-screening appt
Pre-screening (2-3 hours)
- bloodwork
- meet with nurse/Dr to discuss medical history and do a physical exam to ensure you are an appropriate candidate for a trial (they want to “see” you in person)
- Dr then determines if there is a trial available/which trial is most appropriate (I think this has already been determined at the PMH review earlier in the application process)
- Comes back into room to discuss trial criteria and schedule to determine patient interest
- Nurse contacts trial sponsor to see if there is space available in the trial
- If space available, move to screening process
Screening process (3-5 hours)
- Tests to ensure you meet specific criteria (blood, ECG, ECHO, CT)
Biopsy
- required for this trial
- results not shared with Dr or patient
- cannot start trial until biopsy complete
- treatment can begin as soon as the day following biopsy
Genetic Testing
- tissue/blood/saliva collection is required
- results not shared with Dr/patient
- for study purposes
Optional Genetic Reports
- Study sponsor, 23andMe, is offering participants a subscription to their Health and Ancestry Service
- separate from main study and decision does not affect participation in main study
- separate consent forms for health and/or ancestry participation
Comments
So far, the process has been okay aside from a couple of hiccups that arose due to another issue I had. The trial nurse has been extraordinary and has bent over backwards to get this trial started for me!
Biopsy was done at Toronto General (as was the ECHO). I had no issues or complications during or after the procedure. Had a bit of tenderness at biopsy site the following day.
I am having an issue with getting blood return from my port but the trial nurse has indicated that they will get someone to take a look and get it going again.
I have not yet had the saliva collection or the discussion about the 23andMe service being offered. I will probably join the service…I am curious.I have already had genetics testing via BioDiva, so I have results from that and am not concerned that this trial does not disclose the results.I start Cycle 1 next week and will post about my experience.1 -
Thank you @GloHo for sharing this experience with all of us. Thankful you will be initiating this treatment next week and will look forward to your updates as well.
Take care 0 -
Since the drug, 23ME-00610, is in the initial stages of testing, there is not a lot of info on it.
Some info links about this new drug, results of Phase 1, and info re Phase 2.
https://www.globenewswire.com/news-release/2023/04/14/2647346/0/en/23andMe-Announces-Phase-1-Results-from-the-First-in-Human-Phase-1-2a-Study-of-23ME-00610-an-Investigational-Antibody-Targeting-CD200R1.html
If the above links do not work automatically, copy and paste URL in search engine.0 -
Thank you @GloHo
As always, you provide so much information and what can be choices for yourself and others out there. Thank you for taking the time to document in such detail your journey with your trials.
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