Precision oncology trial to be conducted entirely through telehealth
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Researchers are launching an all-telehealth precision oncology trial that will include patients with pancreatic cancer whose tumors have the same genetic mutation.
About 5% of cancers involve a mutation of the gene that controls proteins called fibroblast growth factor receptors (FGFR). This mutation causes cancers to grow rapidly and spread.
The new trial will focus on patients with pancreatic cancer, about 1% of whom harbor FGFR mutations.
To overcome the rarity of this subset of pancreatic cancer, investigators developed a telehealth-enabled clinical trial to reach patients nationwide. Participants will take the study medication in pill form and will communicate with an oncologist through phone calls and video chats.
“We hope that this trial and other trials like it will teach investigators and pharmaceutical companies about a new way of creating access,” study investigator Sameek Roychowdhury, MD, PhD, medical oncologist and associate professor in the department of internal medicine and division of medical oncology at The Ohio State University, told Healio. “This trial, in particular, has some features that make it a good place to start for telehealth. FGFR drugs have well-known side effects that can be managed by telehealth. They are also oral drugs that are routinely shipped in the mail. This provides an ideal first step into telehealth for treating metastatic cancer with a clinical trial opportunity.”
Healio spoke with Roychowdhury about how the trial will be conducted and the expanded opportunities for telehealth in cancer care.
Healio: What motivated you to conduct this study?
Roychowdhury: We have treated four patients with pancreatic cancer who had mutations in the FGFR gene in various basket trials for FGFR drugs. Fewer than 1% of patients with pancreatic cancer have an FGFR mutation but, because of our basket trials, we were fortunate to learn that patients with this mutation responded to treatment and did well. Patients with metastatic pancreatic cancer may not live more than 6 to 12 months, but most of these trial participants lived several years because of treatment. We became interested in this subset of patients who do very well and wanted to study this further. Much of this happened via telehealth during the pandemic, and that gave us the idea to pursue this with telehealth in a clinical trial.
Healio: How will you conduct the study?
Roychowdhury: We hope to open it within the next 4 months at Ohio State. We will be the only clinical trial site, but we will be treating patients anywhere in the country. Physicians can refer patients, or patients can refer themselves. We want to get the word out about this trial.
Patients can have a telehealth visit to see if they are eligible. They will undergo blood work, CT scans and eye exams locally. We will get that data and review it for eligibility. We will work with local oncologists to facilitate these steps.
Our investigator team at Ohio State will do the study assessments and provide the drug, which is an oral therapy that will be shipped to patients. We will monitor how they do, their side effects, and any need for regimen adjustments or supportive care, such as IV fluids.
Healio: How is this different from other telehealth studies happening now?
Roychowdhury: Most other telehealth studies aren’t treating patients with a novel therapy for their cancer. They tend to be about nutrition and exercise counseling, pain management, , access to their physicians or patient satisfaction. In this trial, we actually are treating patients with advanced cancer with a novel therapy.
Healio: What are some of the challenges to conducting an all-telehealth clinical trial?
Roychowdhury: This is new to everyone. Every step of the trial activation process raises many more questions, and we hope our lessons learned will help others. We’ve been fortunate to get advice from Kelly Bolton, MD, PhD, assistant professor in the division of hematology at Washington University in St. Louis. She leads a study for ivosidenib (Tibsovo, Servier) treatment for patients with clonal hematopoiesis that opened around the time of the pandemic, and she had to adapt. She’s been very helpful and has led the way for us. We hope that through what we accomplish, together with what Dr. Bolton has achieved, we can show that this is feasible and there is a way for us to find the patients we need without having 200 clinical trial sites.
It's a limitation for drug companies to pursue these types of rare targets. However, if we can have a mechanism to find these patients, approach them and offer treatment, I think we lower the bar for being able to do these types of studies. That’s one of the biggest barriers to the development of precision oncology therapies. We have the drugs, but the patients just can’t come and get them. Our trial is an ideal setting to start with. Doing more complicated or more toxic regimens is probably a bit further away right now, but the possibilities are ahead of us.
Healio: What are the potential implications of this study?
Roychowdhury: There are so many obstacles to being able to participate in a clinical trial. Every patient I have ever had participate in a traditional clinical trial has always had a loved one who brought them to their appointments. Not everyone has that. There are some patients who could never get to do a clinical trial, when there might have been something that could have helped them. Being able to engage a patient with their local physician, without leaving their hometown, can overcome barriers for participation. It’s a scientific advance to use telehealth to bring this opportunity. I believe it’s also a patient-centered advance to bring access and improve the diversity of patients who participate in clinical trials.
Reference:
- The Ohio State University. ‘Smart Drugs’ give new hope to some patients with advanced pancreatic cancer (press release). Available at: https://cancer.osu.edu/news/smart-drugs-give-new-hope-to-some-patients-with-advanced-pancreatic-cancer. Posted June 7, 2023. Accessed April 2, 2024.
Sameek Roychowdhury, MD, PhD, can be reached at The Ohio State University, 2050 Kenny Road, Columbus, OH 43221; email: sameek.roychowdhury@osumc.edu.
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