› Forums › General Melanoma Community › Important Question!!
- This topic has 7 replies, 5 voices, and was last updated 6 years, 3 months ago by
MelanomaMike.
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- September 29, 2019 at 7:56 pm
Hi guys, i have a question concering something i found out about my specific med on an Incyte page (the sponsor)that ill be starting INCMGA00012, (just that drug, not in combonation with the other drug ill be taking Epacadostat) a short report of its phase 1 study dated last year September 2018, could someone explain what Radiographic and Clinical Progressions mean? Heres what it read: Overall, 107/162 (66%) of patients had discontinued treatment as of the data cutoff primarily due to Radiographic progression (40%) and Clinical progression (11%)……
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- September 29, 2019 at 8:26 pm
Hi Mike
My understanding is Radiographic progression would be evidence from a CT scan etc. Clinical would be something identified as part of an appointment in a clinic e.g. presentation of a new skin met or similar.
Regards
Mark-
- September 29, 2019 at 8:44 pm
Thanks Mark, atleast the beganing part of the study had only 11% Clinical progression (new tumors popping up) that tells me its a decent drug thus far! Im still up in the air on what Radiographic progression was, scan show new mets? Isnt that the same as clinical? Mind you, this study is without the drug Epacadostat with ill be taking in combo with the INCMGA00012. And, to ad wich i should have mentioned in my post, the cancers that where being treated where Cervical, Sarcoma and Endometrial cancers…
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- September 29, 2019 at 9:48 pm
Hey Mike,I actually found the poster you are looking at on the Incyte website. This is an interim analysis of MGA012 and the results to date. Progression-free survival is a major primary endpoint in cancer research so progression (whether radiographic or clinical) should be defined in the protocol. Progression is usually spelled out with specific criteria in the research protocol approved for every study and that could be something like two-fold tumor growth rate/tumor burden increase/number of new lesions in either radiological findings or % change in a lab value for your study (10% increase in LDH, etc) or % change in other areas such as any clinical value in your labs, etc. without the protocol or any publications this was based off of, would be hard to know what that specifically is defined as progression in the poster, but it The hashmark below is from FDA.gov and the process of informed consent. The protocol should also outline when drug would be discontinued based on progression or any other criteria. This is something you can ask Dr. Hamid about as the site Principal Investigator, and if anything is defined in your protocol about what constitutes progression for your trial and what measurement would they use, if any, to discontinue treatment, or what was defined in these other Phase I studies as radiographic progression (# of new lesions/tumors, percent of growth, distant spread from baseline, % change etc) doesn’t hurt to ask:
-an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.
Usually multiple studies are being done for one investigational new drug and the data is being aggregated and collected by the sponsor, but the site prinicpal investigators have access to the Investigator’s Brochure with all the data to date on ongoing studies. It may be outlined there. I’m on the data/statistical side/monitoring so I’m not sure what the patient gets access to at start of the study and what coordinators/PIs share with the subject.. So I would ask either the coordinator or the PI if this information exists in the protocol and if you can get the actual definition for radiologic and clinical progression (what measurements are they using)? etc.
Hope that helps or at least doesn’t hurt. You would need to see what the definition is for this particular poster and for your own protocol.
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- September 29, 2019 at 10:52 pm
You all are so smart! Jackie, MelMel, Mark and of course the rest of our Melanoma Smarties! Thanks Jackie for laying it out a lil clearer as to what i was reading & kudos to you for finding the page! I tried to find it again to link it here but couldnt find it, i had snap shot the area in question….In a nut shell, those percentages doesnt necessarily mean those folks stopped the med cuz it wasnt shrinking tumors or lack of tumor “responses”.. when i read it i was like WTH? lol…ill follow up with Dr. Hamid and the other Doc thats leading the investigation (Trial) Ani Balmanoukian…i realize those short study updates (last current data) has a lot more detail and depth to what i only was able to read, it was short & sweet haha…thanks guys, you all Rock! -
- October 1, 2019 at 12:18 am
Hi Tracey here from Toronto Toronto Canada DoubleTT…Mark R is correct at least it was in my case. Mike it’s just awesome to hear your news about it disappearing in your intestines so happy for! I just finished adjuvant Nivo for my T12 met that got blown up by stereostatic surgery. But now I’m scared shitless again as I have the NRAS gene. Do you have BRAF or NRAS…you are my inspiration to try to become more positive …its really hard …uggghhh -
- October 1, 2019 at 3:12 pm
Whaaaats up my Canadian sister! Long see no time! Haha…yep, Oct 8th is D-Day for the 4th battle of War on Melanoma (3 prior meds didnt work well with me as you know) a clinical trial is set! I know for sure im B-RAF (Neg), but im being analized as we speak (had biopsy last Thursday) to see what kind of DNA make up my strain of Melanoma is, something that wasnt done before when i was with Kaiser (my last USA insurance plan) so, lets see how this works, like iv already boasted, i just may be testing the next BIG thing to possibly cure and or prevent Melanoma!…good hearing from ya sis! Hope you maintain your tumor shrinkage!! Oh! Im still waiting to hear back about my CT scan showing no obstruction in my bowel, really wierd, i know somethings there still!!
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