› Forums › General Melanoma Community › Another Trial Possibility!
- This topic has 7 replies, 4 voices, and was last updated 4 years, 7 months ago by
MelanomaMike.
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- September 18, 2019 at 1:59 am
Hello MRF Family, took a break from “Melanoma Thinking” for a few days haha, hope everyone is good? I hope so..
Ok, update, i have both Brain MRI & CT scans scheduled for next week, 26th MRI & 27th CT scan, ill do the CBC (bloodwork) a few days beforehand, that way i have everything done at once for Dr. Hamid, im ordering the scans to be burned on CD’s for him.
Another one of Dr. Hamids coordinators (forgot his name, ill get use to everyone!) Sent me “another” Clinical Trial agreement form (PDF) to read & learn from, then of course when i come in this Thursday id sign it, the coordinator didnt know what happen to the prior Trial i signed up for, he thinks cuz this one would get started faster but he said Hamid will go over it when i come in Thursday about it. This new Trial is Phase 1b Study by the Incyte Corp. And of course Investigated by The Angeles Clinic using a drug titled INCMGA00012 (non-FDA in study)
INCB050465 ( Non FDA in study)
PART 1-Dose Escalation
Epacadostat in combo with one of above drugs.
Group A= INCMGA00012 w/epacadostat
Group B= INCMGA00012 W/ INCB050465
Part 2 of study is Dose Expansion.
Epecadostat is apparently in “Pill form” so thats a bonus, no sittin’ in the chair for me for an extended hour or so!! Haha.. See? Look at all these Trials that are coming up for me!! That Jang cat is gunna eventually hear from me, hes a liar & a fat mouth telling me there isnt trials for me!! But i digress….Hope everyone is doing ok, gunna go browse our forum & see if theres folks needing some lovin’ or info! 🙂
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- September 18, 2019 at 5:06 pm
So glad you have even MORE options, Mike!! I’m sure Hamid and his team can help you pick what is best for you. But, if you are interested – here’s some data from a pembro/epacadostat trial in 2018:Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).
Mitchell, Hamid Smith, et al. J Clin Oncol. 2018 Sep 28.
Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.
Patients received escalating doses of oral epacadostat (25, 50, 100, or 300 mg) twice per day plus intravenous pembrolizumab 2 mg/kg or 200 mg every 3 weeks. During the safety expansion, patients received epacadostat (50, 100, or 300 mg) twice per day plus pembrolizumab 200 mg every 3 weeks.
Sixty-two patients were enrolled and received one or more doses of study treatment. The maximum tolerated dose of epacadostat in combination with pembrolizumab was not reached. Fifty-two patients (84%) experienced treatment-related adverse events (TRAEs), with fatigue (36%), rash (36%), arthralgia (24%), pruritus (23%), and nausea (21%) occurring in greater than/ = to 20%. Grade 3/4 TRAEs were reported in 24% of patients. Seven patients (11%) discontinued study treatment because of TRAEs. No TRAEs led to death. Epacadostat 100 mg twice per day plus pembrolizumab 200 mg every 3 weeks was recommended for phase II evaluation. Objective responses (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) occurred in 12 (55%) of 22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck. The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
Epacadostat in combination with pembrolizumab generally was well tolerated and had encouraging antitumor activity in multiple advanced solid tumors.
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INCB050465 is a PI3K-delta inhibitor (as best I understand). Here’s a bit of info on that:
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Clearly, not the full package of what this trial would deliver but it’s a little bit of intel on the “parts”. I bet the Edster will have some good stuff for you!
Hang tough with your scannage!! Glad you had a break!!! c-
- September 21, 2019 at 3:56 am
Hi Bubbles, thanks for the links, im learning Epacadostat & Pembro didnt prove efficiency in Over all survival and i believe that study was halted, now MAYBE that time has passed and the Encyte Group made some tweeks to Epacadostat plus im gunna do a different drug not Pembro, maybe itll work better together, im already hearing the VERY first 250 patients before me, most have had tumor shrinkage and other great reponses and tolerability was great! Fingers Crossed! Eyes crossed! -
- September 21, 2019 at 4:02 am
Oh! Ed already put up a link to with Epacadostat and Pembro trial awhile ago, way before i brought up, i found him on the web! (MRF of course) Haha…
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