Navigating Clinical Trials – IMCgp100

As most readers here know, ocular melanoma is an aggressive form of eye cancer which spreads outside the eye (metastasizes) in 50% of patients. When that happens, the prognosis is poor and there is currently no “standard of care”.

While participating in Clinical Trials is my last choice, it is often the first option presented to patients.

When I experienced life threatening side effects from systemic immunotherapy, I was forced to start to consider Clinical Trials in addition to undergoing liver directed treatments. The first step was a liver biopsy for the specific purpose of running a complete gene panel and to have a blood test to see whether I am HLA A201 positive or negative.

The reason for this specific blood test, normally conducted to evaluate whether someone is compatable for organ donation, is because there is a Uveal (ocular) Melanoma Clinical Trial which is only for those who are positive for HLA A201.

IMMUNOCORE, a T Cell Receptor (TCR) biotechnology company, is testing IMCgp100, described by the company as a “bi-specific biologic T cell redirection therapy“.

“Observation of spontaneous antitumoral T cell response in melanoma patients led to the identification of tumor associated antigens” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2728007/

That is how clinical trials work. Something is observed, then tested in a lab setting. Once it appears that there is potential for a therapeutic application with people, it is tested on people for safety and then for efficacy and dosage recommendations. With no standard of care for metastasized uveal melanoma, patients often look at Clinical Trials as treatments.

Learn More about Clinical Trials in general at https://www.melanoma.org/research-center/participate-science/participate-clinical-trials

The first step to finding a Clinical Trial if your Medical/General Oncologist has not already gone over your options, is to visit the US Government database of Clinical Trials located at clinicaltrials.gov or by visiting a third party vetting site like emergingmed.com

IMCgp100

This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator’s Choice but is pretty narrow:

“To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator’s Choice of dacarbazine, ipilimumab, or pembrolizumab.”

When you view a Clinical Trial online, it’s important to view the Eligibility Criteria. Here is a link to the trial of IMCgp100 sponsored by Immunocore Ltd: https://clinicaltrials.gov/ct2/show/NCT03070392

I was not eligible to participate in this Clinical Trial for two reasons: my blood test showed I do not have the HLA A201 and I do not meet one of the Eligibility requirements of “No prior systemic therapy in the metastatic or advanced settings”.

So this is a good reminder that patients may want to consider Clinical Trials as their first “treatment” if in consultation with their doctor, their disease is such that they have the time to try a trial first because the order things are done in can make the difference between being eligible in the future or not.B

One thought on “Navigating Clinical Trials – IMCgp100

  • December 20, 2018 at 9:09 am
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    My experience with the new IMCgp100 drug as well as participating in the phase 2 clinical trial at Duke has been excellent. I am under the care and outstanding leadership of Dr. April Salama and her top notch research team. Participating in a clinical trial is not for everyone due to various reasons or circumstances. It was the choice I made after looking at all options as well as being fortunate enough to be eligible and being randomized for the new drug arm. IMCgp100 shows promising results for ocular melanoma so far. The IMCgp100 drug side effects are less severe in most instances vs the FDA approved immunotherapy drugs. In my case the side effects kicked in after roughly 5 or 6h starting with a skin rash, itchy and burning skin followed by lower blood pressure and some nausea during my second ramp up infusion. The side effects where relatively easily controlled with fluids, antihistamines, cortisone cream as well as anti nausea meds. The first 3 to 4 times require a hospital overnight stay to ensure the side effects are monitored and controlled. In my case the side effects are gone within a few days. There are many cases where patients experienced chills, fever and weakness amongst others. I am fortunate enough to have never experienced any of those. I am trying to stay active and usually go for a run a few days after the treatment. The side effects become less severe every time and seem to be much easier to tolerate.

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