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Los Angeles artist Jim Day had just overcome an incredible feat. After suffering a tragic motorcycle accident, he learned to walk again despite doctors telling him it wasn’t possible. The accident and subsequent recovery had taken him away from his passion of sculpting for nearly a year and a half, and he was ready to get back to work.
One day in his studio, while trying to work through the back log of projects left in the wake of his accident, Jim abruptly lost his hearing and felt lightheaded. When his hearing slowly started to come back, he was able to call for an ambulance.
In the hospital, a neurosurgeon identified a large mass growing on Jim’s head and promptly scheduled emergency surgery the following day. After several days of feeling disoriented and confused post-surgery, Jim began to mostly feel like himself again. Except, he developed a condition known as pure alexia: difficulty reading, despite retaining the ability to write and spell.
Two weeks later, Jim returned to the hospital. His staples were removed, and he was told to seek follow-up care with a different provider. Overwhelmed and struggling to parse through the stack of paperwork that was handed to him, he recognized one word amongst the jumble, “MELANOMA.”
Indeed, Jim’s large brain tumor was confirmed as melanoma, but according to his doctors, scans did not reveal any additional tumors. Jim left the hospital confused by this, and thinking about a small-but-growing lump on the back of his neck that was previously dismissed as lipoma, wondering if it had to do with his melanoma and was somehow missed.
With little guidance and no clear access to follow-up care, Jim started doing some research on melanoma that spreads to the brain and quickly realized that this diagnosis was much more serious than the ER doctors indicated.
Jim called his older brother, a doctor living in Texas, to tell him what had transpired. “My brother invited me to move to Texas to live out the remainder of my life with him and his family… but I had more faith in research,” said Jim. It was at that point he decided to visit a local clinic to see if more could be done about the growing lump on the back of his neck.
Scans and a skin exam at the clinic revealed six additional tumors – confirming Jim’s diagnosis as Stage IV melanoma and indicating that he was nowhere near being in the clear. He was put in contact with the University of Southern California (USC) and medical oncologist Dr. Gino In, and things finally started falling into place.
Jim first began immunotherapy treatment with pembrolizumab. While initial results seemed promising with many of his surface tumors disappearing, new tumors in his lymph nodes emerged. Dr. In suggested alternative therapies as a next step, introducing a phase one clinical trial that was enrolling at the Keck School of Medicine of USC.
“Dr. In sat with me and explained the trial in great detail, even down to the chemistry involved,” recalled Jim.
“I’ve always had a healthy interest in science, so I thought, ‘this makes perfect sense; I want to be a part of this’. We were both really excited about the possibility of the trial.”
In phase one at the time of Jim’s enrollment in 2022, the IGNTYE trial is investigating a new oncolytic immunotherapy called RP1 (vusolimogene oderparepvec) in combination with the immunotherapy nivolumab. Created by study sponsor Replimune, RP1 is a Herpes Simplex Type 1 cold sore virus genetically modified to preferentially infect tumor cells and maximize tumor destruction, while at the same time activating the immune system.
Known as oncolytic viruses, these immunotherapies involve direct injection into the tumor, stimulating local tumor destruction and the possibility of trafficking these immune cells to destroy tumors that have spread to distant sites in the body.
Hearing all of this from Dr. In, Jim had no hesitations. His initial results on the trial were fantastic, with near-immediate reduction seen in his tumors. He first underwent a series of injections1, with the injections occurring over 8 visits every two to three weeks administered by Dr. In. “Not only did the virus attack the tumor it was injected in, but it travelled to other tumors and shrank those as well,” said Jim. Even the tumor on the back of his neck, which had grown to the size of a peach, shrunk significantly.
After completing the RP1 injections, Jim continued treatment with nivolumab to hopefully fully eradicate the remaining tumors. However, some tumors started growing back after a few months, especially the one on the back of his neck. Since he had such great results while receiving the RP1 therapy, Jim began another series of injections, with the main goal of shrinking the tumor on the back of his neck to the point of being operable.
This particular tumor proved quite the challenge for Jim and his care team. Desperate to avoid emergency surgery so that the virus had time to work its magic, Jim did his best to live with the tumor that had started bleeding sporadically and causing him great discomfort.2
Eventually, scans revealed that Jim’s tumor was at a point where it could be surgically removed. The surgery was a success, and when he returned to USC for a follow-up appointment, the reaction was immediate. Staff embraced him, nurses cried, and when Dr. In walked into the room with three other doctors, all smiling, Jim braced for the news. “Surgery was a success,” they told him.
Over the course of his cancer journey, Jim had more than 40 tumors – spanning his skin, lungs, bones, liver, and brain. Today, scans show no observable new growth of his tumors, and many tumors eradicated entirely. “While I still have some tumors, my scans show no observable new growth,” said Jim.
“The RP1 therapy did everything it was supposed to, and I am alive today because of it.”
When Jim first met Dr. In three years ago, his goal was simple: to survive. “You want to cure cancer,” he recalled telling Dr. In, “And I want to be cured.” But as the experimental treatment began to work, Jim’s hope expanded. Still living with melanoma but stable thanks to his involvement in the clinical trial, he realized, “I want to help cure cancer too.”
That shift in perspective didn’t go unnoticed. One day, during a routine visit with Dr. In, the typically reserved doctor asked Jim if he had any idea how many lives he saved by joining a clinical trial. Jim shook his head and Dr. In replied with, “Countless. This therapy is the next breakthrough.” Jim remains a testament to what happens when courage meets cutting-edge medicine.
Reflecting on his journey, Jim remains humble about his contributions to research. The fact is that roughly only 5% of cancer patients enroll in clinical trials, and for melanoma patients, while therapies have improved dramatically, we’re far from a cure for all. Without patient volunteers like Jim, our entire medical research process would stop. Ask your doctor if a clinical trial is right for you.
To learn more about the oncolytic viruses being developed by Replimune, including RP1, please visit replimune.com. For those looking for a clinical trial option for patients with advanced melanoma that has progressed on certain immunotherapies (anti-PD-1 & anti-CTLA-4), please visit https://replimune.com/clinical-trials/ignyte-3/ to learn about the ongoing IGNYTE-3 trial.
RP1 is an investigational agent which has not been approved or recommended by any regulatory agency and its safety and effectiveness have not been established. Jim’s experience discussed during this interview may not represent the experience of all patients who had received RP1 either alone or in combination with nivolumab as part of a clinical trial. Always speak with your doctor about whether a clinical trial is right for you.
1. The IGNYTE trial allowed for additional courses of treatment for patients to receive more than the recommended eight injection cycles, depending on their individual prognosis and discussions with their doctors and the trial team. However, the recommendation was for eight injection cycles in total. administered every two weeks.
2. Patients that experience adverse events while participating in a clinical trial should report those symptoms to their trial physician.
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