Interview with Melanoma Big Dogs Weber and Allison

Hi Jackie! I didnt know that either the investigators or certain trial protocols have failed (or sorta have failed) to collect meaningful tissues along the way during these trials???, however, if i can add, part of “my” Clinical Trial study admission paperwork, asks for “Voluntary” tissues sampling to be donated to Melanoma Science, totaly separate from my own tissue sampling (biopsys) needed for my own personal trial, now, could the lack of Tissue sampling be due to folks “Declining ” to do so? And, as far as my personal treatment plan for the next “possible” 2 years of this trial (if i tolerate it or its working) Dr. Hamid says a good number of tumor biopsys will be performed & analyzed in great detail along the way to study the INCMGA00012 & Epacadostat activity within my tumors so, sounds like my team is doing right! A far cry from what Kaiser has done for me since my diagnosis in 2008!!

Hey Mike, Just to clarify, my estimated percentage was from studies I’ve been involved in directly or tangentially to date. It does seem to be trending towards collecting biosamples, etc and big biosample registries are being developed as we speak. Now, I think Dr. Allison and the community must be seeing a less than 100% marriage of clinical trials collecting biopsies (it would be interesting to know the percentage of clinical trials that collect biosamples currently) as well for him to mention it, and clearly many trials in the past have only looked at clinical outcomes and have not collected samples since traditionally clinical trials have usually been focused on clinical endpoints such as progression free survival, pain, absense of disease or any other clinically defined endpoints based on the disease state. And trials that are involved with Investigational New Drugs are looking at safety and efficacy endpoints as big part of their submissions for approval at end of the clinical trial phases. I think the trend we’ve been seeing is to add collection of tissue samples/biorepositories to the protocols and informed consent as secondary research. Especially with precision medicine, they are now looking at genetic materials and tissue samples/biomarkers to create a group of patients they think will respond to a certain drug, etc. . We see that in melanoma with all the testing for expression of different things and subsequent enrollment in a trial based on that inclusion criteria. There are ethical implications for all of this in terms of Human Subjects, the clinical trial world is still trying to operationalize all these things ethically, etc. I thought this was interesting discussions of the challenges: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396357/

The issue you brought up is great and you are right, there is always a percentage declining voluntary consent. This is an Informed Consent issue when there is request for samples or genetic materials that is voluntary and a separate consent process than the consent for the treatment protocol etc. Those of us in clinical research are expected to follow the guidelines of Good Clinical Practice of the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. There are also FDA Code of Regulations that must be followed if you are working on a trial for a investigational new drug before approval. One of our main committments is to protect Human Subjects rights through Informed Consent. And often Informed Consent for allowing biosamples can be separate from consenting to treatment or requires a separte signature from the patient. Good Clinical Practice is that the subject is informed of exactly what is going to happen to them in terms of treatment, where their data will be stored and how long and where, etc, and if any biosamples are collected and stored where will those be stored, de-identifed and confirmation of your rights if you voluntary decline. It’s a big issue as you have pointed out but it is absolutely the subjects right to decline if that is outlined in the protocol and consent. I’m not sure you want to read this all Mike, but Informed Consent around tissue samples is a really complex area since it is becoming so apparent how important the biopsies are as Dr. Allison pointed out: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-faqs-recommendations-and-glossary-informed-consent-and-research-use-of-biospecimens-and-associated-data/index.html

Your team is absolutely doing right, rock on!

Your so smart! Hehe, im so glad you & a few others are here, iv learned so much from you all as well as my own experiences on my end thru my onco’s & docs..
When i signed off on donating a specimen (tissue sample) i know (or hope anyways) its for true Melanoma sciences and observation purposes, this whole trial thing is a far cry from the regular FDA approved type treatment, ya know, the whole 9 yards of the preparation, the Legal aspect, the intense monitoring, etc but like they said, once i get passed my first infusion ill be ok, the beganing, and the day of my first infuse is time consuming, apparently the 1st infuse will began at 7am and ill be there most the day to be monitored, not because its a slow dosed med, (i actually need to ask how long a bag of INCMGA00012 is! 30min, 60min or 90min?) But to make sure im handling it ok…
Thanks for talking about this subject, good to know the Ins & Outs!!