My name is T.J. Sharpe, I am a Stage IV melanoma patient, and I just celebrated my 40th birthday, thanks to clinical trials that turned a terminal prognosis around.

A few years ago, I walked into the ER with what I thought was a bad flu, and left sixteen days later with the Stage IV diagnosis. My wife had given birth to our second child, Tommy, a mere four weeks before. We had a 2 year old daughter, a house, and a nice active family life in Fort Lauderdale, Florida.   So when the oncologist came into the room and said, “I will be surprised if he is here in two years”, you find the best treatment options and you find them now.

34 months, six surgeries, four treatments, and two clinical trials later, I am on the verge of being cancer-free. There was never a guarantee of success, but knowing I was getting the most cutting-edge treatment, by some of the brightest minds in the melanoma world, gave me confidence that I would be one of those dots that stretched waaaay out on the survival curve. I chose a trial (well, two trials) because it gave me the best chance for what I desired, a durable long-term response.

By happenstance, the oncology world was undergoing what may be a fundamental shift in cancer treatment, with the use of immunotherapy drugs to unlock the body’s own cancer-fighting defenses. Metastatic melanoma treatments are at the crest of that wave, and I was fortunate to be guided towards trials that offered me several treatments working on a similar premise; that our bodies can fight and beat cancer, if given the proper tools to do so. In my case, this was an ipilimumab (Yervoy) + TIL/IL-2 trial, followed by the breakthrough anti-PD-1 drug pembrolizumab (recently approved as Keytruda).

The first clinical trial combined the melanoma immunotherapy drug, ipilimumab, with Tumor-Infiltrating Lymphocytes (TIL) therapy – where a tumor is removed, and the “best” T-cells are cultivated and multiplied to 50+ billion before being reinserted into your body. When I asked the lead investigator how others had fared on this treatment, he looked at me, paused a bit, and replied, “As far as we know, you’re the first person to ever try this combination in this order.” While some may have been scared off by that uncertainty, my only thought was, “Great – no one has EVER failed this before!!!” It even became the name of the blog I write, chronicling the ups and downs of cancer treatment with my trials – the “Patient 1” blog at

Having been an IT consultant in the pharmaceutical world right out of college, I understood more than most how the clinical trial process works, and more importantly, why they were of such benefit to the participant. Yes, without patients, drug companies cannot patent and profit from the products, a byproduct of the free market system often offered as a rebuttal to standard treatments by alternative practitioners. If you’ve ever been around the doctors, the researchers, or the dedicated people in the industry, whose every day goal is to give life, peace, and hope to those facing medical challenges, that view is quickly dismissed by the realization that thousands dedicate their professional lives to finding cures for cancer and other diseases. The treatments we currently have are a result of others taking a measured risk for the opportunity to get the most promising treatments currently available. I was more than willing to be a part of that medical future, for a chance that the durable response would give me the opportunity to watch my children grow up.

Was the trial process perfect? No, of course not. We had issues getting the first trial started, which led to multiple calls to one pharma company’s legal department demanding they rubber-stamp the trial approval so we could begin my treatment. There was a month-long delay during the trial as a result of a diverticulitis; our options were abandon the trial or get a colostomy bag; we faced the decision of giving up before even getting to the main cancer-fighting part (and choosing the bag versus opting out). We found out the melanoma had progressed after the trial finished. We scrambled to come up with Plan B, even while being hospitalized by tumors pushing onto internal organs. There were clashes with the second trial’s oncologist, who was not in sync with his team and not used to a patient pushing back on him and saying, “not knowing is not good enough”.

In the end, the combinations worked, and have continued to work nearly three years after the initial Stage IV diagnosis. We’ll never know if one trial’s failure paved the way for the second one’s success; immunotherapy combinations are being shown to have significantly better results, but it will be years before doctors understand fully how they work synergistically. It is reasonable to assume, however, that the prognosis of “I’ll be surprised if he’s here in two years” likely would have become a self-fulfilling prophecy had I stuck with the standard of care chemotherapy.

My case may be extreme, but it is illustrative of why trials are important options for every patient to consider, no matter what the diagnosis may be. It’s your life, and your choice, what treatment option is the best fit for you. Giving patients all available choices, including clinical trials, will further medicine while providing patients with the opportunity to select the most advanced treatments available – and hopefully give more families the life we have recovered.




Image courtesy of Naypong /

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