National clinical trial open at Massey will examine short- and long-term outcomes of patients with COVID-19 and cancer
A nationwide clinical trial funded by the National Cancer Institute and now open at VCU Massey Cancer Center will examine the short- and long-term outcomes of patients with COVID-19 and cancer to gain a more comprehensive understanding of the impacts of infection. The NCI COVID-19 in Cancer Patients Study (N-CCaPS) is a longitudinal natural history study that will include a national registry of blood samples and radiologic images from adult cancer patients infected with the novel coronavirus to analyze disease pathology.
“This clinical trial will allow for a more in-depth investigation of COVID-19 pathology in cancer patients and could contribute to a deeper understanding of the immunological impacts of infection,” said Andrew Poklepovic, M.D., study site principal investigator, medical director of Massey’s Clinical Trials Office, medical oncologist and member of the Developmental Therapeutics research program at Massey. “The findings from this study will guide the clinical treatment of cancer patients affected by COVID-19 through the course of the pandemic.”
For a number of reasons, cancer patients on active treatment may be at greater risk of more severe infection with COVID-19 and poorer outcomes. Common risk factors associated with cancer, including old age and smoking, correlate to worse outcomes from COVID-19 infection. Additionally, cancer patients often have suppressed immune systems due to the disease itself or from their treatment, making them especially vulnerable to the novel coronavirus.
Recent findings indicate that cancer patients are nearly twice as likely to die from COVID-19 infection as the general population, according to a report from the World Health Organization-China Joint Mission on Coronavirus Disease 2019.
However, existing data on how COVID-19 infection impacts cancer patients is severely limited, and much of this data is specific to the Chinese population. Because the disease was not discovered until December 2019, long-term outcomes from the novel coronavirus are unknown for cancer patients as well as the general population. Early reports indicate that prolonged intubation and heavy sedation while on a ventilator could have negative long-term impacts, including lung damage and cognitive impairment, among others.
Cancer patients are also at risk of having to stop, alter or delay their cancer treatment if infected with COVID-19, potentially leading to worse outcomes associated with their underlying disease.
“It is critical that we acquire long-term data to gain a comprehensive understanding of how COVID-19 affects cancer patients,” Poklepovic said.
How patients respond to certain FDA-approved immunotherapies for cancer, including PD-1/L1 inhibitors and CTLA-4 inhibitors, is of particular interest in this study because these drugs are associated with an overreactive immune response called cytokine storm. A wealth of new data has indicated that cytokine storm is also a common factor in severe cases of COVID-19.
“A larger understanding of the course of COVID-19 infection in cancer patients actively being treated with these immunotherapies could have significant implications for all cancer patients as well as the general population,” Poklepovic said.
Massey is one of four cancer centers in Virginia participating in this trial and one of more than 700 study sites in the nation. The goal is to enroll 2,000 patients nationwide on this trial.
Questions about this clinical trial at Massey should be directed to Robin Toft, study coordinator, at (804) 628-0282 or firstname.lastname@example.org.