I have gone though more than a year of chemo therapy with little success and the oncologist is now trying immunotherapy. I understand there is a 2nd phase trial with Keytruda specifically addressing Mesothelioma going on in Chicago.
I have Mesothelioma and have gone through 6 sessions of Chemo w/two 'maintenance' follow ups. Am now on Keytruda. The trial you are referencing is one being done by the University of Chicago. Its National Cancer Institute identity is: NCT02399371 (Ability of PD-L1 to predict response [ Time Frame: Up to 3 years ]) It is in ARM II of Phase II of the trial. ARM I I assume is finished by this time. These patients were those identified in ARM I of the Phase II as being PD-L1 ( 'Programmed Death-Ligand1' positive expression ). I don't know how many patients they have now, but the goal was 65 patients. The primary goal was: "Ability of PD-L1 to predict response [ Time Frame: Up to 3 years ]" While this trial has been going on for some time I think it might be difficult to get any feedback at this point. Keytruda is being supplied by Merck here and drug companies in general are loath to let the competition how and what they are doing. However, if you make the effort and get any success, I would appreciate it if you could/would forward anything you find out there.
Have gone through two sessions of Keytruda IVs over the past 5 weeks - IV each 3 weeks. This is not a U. of Chicago effort, but due to a "compassionate usage request" by City of Hope Hospital, here in California. Otherwise the cost runs some $150,000 on a yearly basis. Am the only Meso patient presently going through this process there.
The side effects ( I find ) are as severe as the Alimta/Carboplatin combination in the chemo sessions. The difference is ( for me ) that the Keytruda IV impact seems to take about 4-5 days before it 'hits' you. 'Chemo' hit me in a matter of hours. At this early point I can detect no other changes in myself other than the side effects - fatigue, nausea, muscle/joint soreness, and weakness, primarily. The series is scheduled to run through four sessions, three weeks each. At the end, I will be given a CT Scan ( NOT a PET Scan ), to attempt to determine the results of these IVs. Have gone through so many PET Scans that my cardiologist is concerned the the accumulated radiation has impacted one of my heart valves, thus the CT Scan instead.
I also have some skin cancer, 'Squamous', on head and neck. There may be a BAP1 gene/BAP1 protein relationship between these two. ( another 'rabbit hole' to go down ). Supposedly, Keytruda has about a 16% chance of 'addressing' this as well. So far, I note no change in the lesions I currently have. I have no idea, though as to how fast this drug is supposed to work. At this point, though, it is probably too early to form any substantive evaluations. At the end of this series I hope to have a better feel and will be back here.
I have little advice to give. To determine whether you are PD-L1 positive or not ( to qualify for the ARM II in Chicago ), would require processing a fresh biopsy. Am under Medicare, myself, so this was not a part of my own original 'FISH' analysis. There are a lot of biomarker type tests that can be run, almost endless, but Medicare/Supplemental insurance requires inspirational justification to warrant these. The question becomes, how 'adroit' is your oncologist?
I research the Internet approx. 3 hrs a day over the past 18 months. Lots of interesting stuff going on in the bio medical field, but at this point I don't see much that would cause me to say, "Ah hah!!", to address our problem. Lots, too, of interesting work in the CAR-T area, but this is basically for 'blood' tumor type cancers, like leukemia. You and I have what's called 'solid' cancer. For this, we may want to browse some in the TCR area. The CAR-T effort seems far ahead of what's happening in the TCR-T field, offers promise, but ( at least to me ) I see heavy risk in the CAR-T area, particularly considering the cost(s) involved. All of the above,of course, 'IMO'.
I wish you the best of luck...
- Keytruda Information for Consumers
- Keytruda Information for Healthcare Professionals (includes dosage details)
- Side Effects of Keytruda (detailed)
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