Venita Currie (Host): Welcome to another episode of UAMS Health Talk, where we explore various health topics to help you lead a healthier life. My name is Venita Currie. Today, we have the pleasure of hosting Matt Kovak, the Executive Director of the Cancer Clinical Trials Office at the Winthorpe P. Rockefeller Cancer Institute.

Matt has been a critical part of UAMS since 2010, advancing through roles from research technician to his current leadership position. Join us as we dive into the world of cancer clinical trials and discover how tomorrow's treatments are being shaped today. Welcome to the show, Matt.

Matthew R. Kovak, MS, CCRP: Good morning. Thank you so much for having me.

Host: I am guessing when people find out what you do for a living, they are intrigued. At least I know I am. Tell us your story. Tell us how did you become involved with clinical trials?

Matthew R. Kovak, MS, CCRP: So I began at UAMS in 2010, working on my master's in biochemistry and molecular biology. I was working in a basic science lab where we were studying different protein interactions and really how that affects different types of cancers, specifically prostate cancer. Because of my interaction needing samples, I began working with the cancer clinical trials office not long after that time.

And it really shaped me into then moving over to cancer clinical trials where I was beginning to work in regulatory and then working my way up now to be the director of the office. You know, when I started in 2014 in the clinical trials office, we had around 10 staff. As it is today, we have 87 staff with a portfolio of more than 300 cancer clinical trials.

We enroll more than 1,200 participants a year with 250 or more of those going on therapeutic treatment clinical trials, which are really the utmost important for really shaping tomorrow's treatments.

Host: You know, and I think, when people hear the word clinical trials, they've probably heard it before, but they may not know exactly what that means. Can you kind of walk us through what it means and why it's important?

Matthew R. Kovak, MS, CCRP: Absolutely. So I like to quote the World Health Organization and the National Cancer Institute on their definitions of clinical trials. So the World Health Organization says clinical trials are a type of research that studies new tests and treatments and evaluate their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions, including drugs, cells, and other biological products, surgical procedures, radiological procedures, devices, and other types of preventative care.

The National Cancer Institute defines it as a research study that tests how well the new medical approaches work in people with cancer. These studies test methods on screening, prevention, diagnosis, and disease. And this is very important for, you know, shaping what new treatments can be standard of care for tomorrow.

Host: Could you give us a little more information on what kind of research your team is working on? Like, what are you trying to solve? What are the research options you're trying to provide?

Matthew R. Kovak, MS, CCRP: So really one of the big things that we're looking at again, as I said, is these treatment clinical trials, these trials that are looking at different treatments. We have what we call 13 different disease modalities in breast, brain, GI, GU, lung, Myeloma, leukemia, lymphoma, sarcoma, and we have a dedicated phase one unit, so our phase one studies are what we like to call first in human.

These are the first time these drugs are being looked at and really they're the basis of what moves on to larger clinical trials to really shape the standard of care practice.

Host: Some of our listeners may be thinking that maybe they should be a part of a clinical trial if they are battling with some form of cancer. Can you tell us how that works? Like how are participants selected and how do they become a part of your clinical trials?

Matthew R. Kovak, MS, CCRP: What I like to tell patients that are either new to the Cancer Institute or new even to learning about clinical trials is it's best to talk to your treating physician. They are the ones that know what trials we have open and what's available. We also get a lot of folks from outside the community who reach out. We have a phone number, an email address, a website, that really have a plethora of information. So if you're new and you don't have a physician established, I always like to tell patients to feel free to look at our website, the  Winthorpe P. Rockefeller Cancer Institute has a wonderful website. Clinical trials are right at the top of that website. You can always call our office at 501-686-8288, or send us an email at cancerclinicaltrials.@uams.edu.

Host: As patients have that conversation with their physicians, I'm imagining there may be some risks that they may be concerned about, if they go through and participate in a clinical trial. Can you talk about what the risks are?

Matthew R. Kovak, MS, CCRP: Absolutely. So with any clinical trial, there's an informed consent process. These are lots of times lengthy documents that outline the procedures that will occur during the clinical trial, as well as any potential adverse events that could occur. These documents, as well as the actual study, which has a large protocol, have been reviewed by scientists in their field.

They've gone through an institutional review board process to ensure that the trial is based on sound science. If a participant takes place in the trial, their safety is protected through that informed consent process, careful review, and approval of the clinical trial and a protocol, as well as continued monitoring. That informed consent is really the essential process in which the participant goes through with the investigator as well as with the clinical trial office staff that explains the trial and what they're taking part in.

Even after the participant signs that consent form, they can leave the study at any time. They can always ask questions and if new information becomes available, the clinical trial office team will let them know immediately.

Host: If I'm remembering correctly, Matt, you said your team is working on more than like 300 different clinical trials. Is that right?

Matthew R. Kovak, MS, CCRP: That's correct.

Host: Can you share any patient stories of success of a patient that participated in the clinical trial and some good results that came from there?

Matthew R. Kovak, MS, CCRP: Absolutely. We've had a recent case study for one of our phase one clinical trials that was looking at novel monoclonal antibody that was looking at a specific inhibitor. This was a first in human study. African American male that had been diagnosed with kidney cancer had gone through extensive therapy that had all failed.

He had unfortunately had metastasis where the disease had spread throughout his body and he really had no other options. He was enrolled into the clinical trial, in February of 2023. He received 31 cycles of this novel drug, receiving the last cycle in October of 2024. He saw complete disappearance of his cancer.

He had what's called a complete response where the cancer disappears. He is back to his normal everyday life. He is just a wonderful story. And I have more of those that I could share if I had more time. Now, while this is not always the case, it's wonderful when we do see these cases, and then the hopes that this phase one study will then move into a phase two or phase three study to hopefully see change, especially in this kidney cancer population.

Host: That is so inspiring. Please tell us, what does that phase two and three look like? How does it become available to others that may need that kind of treatment?

Matthew R. Kovak, MS, CCRP: So, new protocols have to be written. Again, like I talked about, it'll end up going through process of the FDA approval, the Institutional Review Board approval. Once all that's done, a study can then be opened up and a lot more patients. Where this study really only had, less than a hundred patients that were on it.

These phase two and three studies will likely see 500 to a thousand patients. And that's really what the FDA is looking at to make that determination on whether this can then be considered a new standard of care drug.

Host: And once that process has been completed, how many years will it take for it to be kind of offered for anyone else?

Matthew R. Kovak, MS, CCRP: So that can take time. Some of the quicker ones can move in a three or four year process, but some can take even longer, just depending on how long it takes to recruit participants. Some say it can average almost 10 years to see that difference, which is unfortunate. But we want to make sure everything is safe.

We want to make sure that we're not putting patients in danger by any means. And really with clinical trial, you're getting an added layer of support. You're getting your clinical team with your doctors and your nurses, but now you have at UAMS, 87 other staff who have your back, who are there to see you through this process of having a cancer diagnosis.

Host: You know, from our conversation, it seems like the ultimate goal for a clinical trial is to transform patient care. So Matt, when you think of a future version of cancer clinical trials, what do you see? What do you envision being different?

Matthew R. Kovak, MS, CCRP: Really, my big vision is that, especially here at UAMS, is that we'll be able to offer every patient that comes to UAMS the opportunity to be on a clinical trial, that it's going to be more driven towards that singular patient to where everybody is different. But it's important that we have options for everybody to be able to participate in clinical trials and know that they're safe and the effective means of hopefully one day eradicating cancer.

Host: Thank you, Matt. I really enjoyed our conversation today and I hope our listeners have a better view of how hard your team is working to improve their lives. That concludes this episode of UAMS Health Talk. If you want to learn more about clinical trials at the Winthorpe P. Rockefeller Cancer Institute, please visit cancer.uams.edu/clinical-trial or call 501-686-8288. Stay tuned for our next episode and until then, stay informed and take care of your health.