PRAME positive

May I ask which trial it is? I just emailed my doctor to see if I am PRAME positive as I have run across this antigen in a variety of trials. I wish you good luck if you choose to go with the trial.

The trial is for an experimental drug identified as "IMC-F106C" and the study is being done at Mass General Hospital in Boston. It would be given in combination with one of about six other, currently approved drugs for cancer. This is a Phase 1 trial which means it's being done to establish a safe level of dosing. There have been previous studies testing the experimental drug as a single agent, also to establish safe dosing. The potential side effects are quite frightening and the time committment is significant. I'll have a lot of questions for the oncologist when I meet with him in 3 weeks.
Have you been in any clinical trials, and if so, for what cancer? I'm curious about any other trials for ovarian cancer being done at other cancer centers. The whole thing is daunting to say the least.

Did you have the feeling that they had other patients on this trial and that they were doing well? (I was contemplating clinical trials myself, and this one is nearby. I don't know if my tumor is PRAME positive.)

There are lots and lots of clinical trials on ovarian cancer, more than for endometrial. It is somewhat bewildering. You can look them up on clinicaltrials.gov, although that tends to be a bit out of date. Individual hospitals/cancer centers usually have a listing of their own trials, and these are often more up to date.

That’s a good question which I haven’t asked. The protocol for the trial is no joke, quite terrifying actually.
I did as you suggested and researched clinical trials for ovarian cancer. Given the amount of monitoring required it probably isn’t feasible for me to do anything outside my general location.

What trial are you considering?

What's terrifying about it? Informed consent forms have to list all the known possible side effects, even rare ones. It's usually possible to figure out which are the common ones that you're actually likely to have.

Different trials have different amounts of monitoring, so there are some where you only have to go every three or four weeks, except during the screening at the beginning. So you probably could do one of those that was a few hours away. Phase I trials have the most monitoring. Phase 3 trials have control arms where they give you some kind of standard chemo instead of the trial drug, so I'd avoid those. I'd also try to avoid the dose escalation part of a phase I.

I have already done 4 clinical trials and have had 6 different line of treatment, so I have fewer options. (Many trials restrict enrollment to patients with only 1-2 prior lines of treatment.). I was looking at the exact same IMC-F106C trial as well as several others. I'll do whichever one I'm eligible for that I can get into fastest.

If I were you, unless you get the feeling that the IMC-F106C trial is working great, I'd probably look for a trial of an antibody-drug conjugate (ADC). These use an antibody to target chemotherapy drugs specifically to the cancer. There are several of these with different targets. Elahere is one that has been approved for ovarian cancer, so I assume they already tested your tumor for the target (folate receptor alpha) and it was negative. Similarly, I assume it's negative for HER2, or you would be eligible for an approved ADC. Clinical trials are a bit of a crapshoot, but what are you going to do.

@amywells I was unfamiliar with PRAME so I did some research and found this article in Frontiers in Medicine:

Frontiers in Medicine; PRAME immunohistochemistry:

-- https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1265827/full

In the first paragraphs of the Introduction, the above article explains what PRAME is, how and when it was discovered. At first I was a little confused as PRAME pertains to melanoma and cutaneous (skin) cancers but to a smaller degree it's found in the endometrium, ovaries, and the adrenal glands. This article focuses on a comparison of different types of testing but explains PRAME quite well.

@val64 is very familiar with this lab science and her recommendations are spot on. As for consent forms? Yes, the boards that approve studies (called Institutional Review Boards) are rigorous and requires that the perspective participant/patient be informed of anything and everything know that could happen. It doesn't mean that this will happen to you and as @val64 wrote it's possible to discern which side effects may be more likely (more common). There is a principal investigator indicated on the consent form so if you have questions then this is the person to contact.

As your options become less it's reasonable and good practice to offer clinical trials to patients. If I were you, I'd look into the clinical trials recommended by your oncologist and then do whatever trial you can get into sooner rather than later.

Agree with Helen that you should look into trials recommended by your oncologist. But it's also worth looking beyond what they recommend. Both from my personal experience and that of others on Mayo Connect, most doctors are only going to recommend trials at their own hospital. This is probably mostly from lack of knowledge about other trials, although they are also under some pressure to prevent "leakage" (patients changing hospitals). Many oncologists probably can't even be relied on to recommend all suitable trials at their own hospital. The best people to get in touch with are the doctors who are the principal investigators on several clinical trials. They are most likely to know what's available at their own hospital. (Keeping up with what's available is non-trivial. Trials open and close; eligibility requirements keep changing; and this information isn't publicly available in real time.)

Val64, that is very helpful information. You obviously are very knowledgeable about this process. I hope to be helpful to other people as you are. My oncologist has recommended that I consider meeting with people at Sloane Kettering in NYC and Tampa General Hospital who are apparently doing other clinical trials, although it's a little confusing when I look them up. This is my first recurrence so I'm not sure if it makes sense to wait with a clinical trial until my next recurrence. I have a repeat scan and labs and meet with my team in two weeks and will hopefully have more clarity on next steps. I'd be interested to know if you do decide to do the IMC-F106C trial.

Helen, I appreciate your sending the link for the article about PRAME. I don't quite understand the science yet but am working on it.

I have a friend who went through a PRAME trial for melanoma… She is now considered in remission however she has dangerously high potassium levels and they can’t seem to get them down. She believes they are a result of the trial.