Researchers in Canada launched a phase 3 trial of IMM-101, titled CCTG IC.8, with the hope of strengthening the immune system of patients with cancer.
Canadian researchers have launched a clinical trial, titled CCTG IC.8 (NCT04442048), aimed at strengthening the immune system of patients with cancer during the coronavirus disease 2019 (COVID-19) pandemic.
The study will be evaluating the use of IMM-101, a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections. Researchers from The Ottawa Hospital came up with the idea for the trial and worked with the Canadian Cancer Trials Group (CCTG) at Queen’s University to plan and carry it out in centers across the country.
“An effective vaccine that provides specific protection against COVID-19 could take another year or more to develop, test, and implement,” study lead Rebecca Auer, MD, MSc, FRCSC, surgical oncologist and director of Cancer Research at The Ottawa Hospital, as well as associate professor at the University of Ottawa, said in a press release. “In the meantime, there is an urgent need to protect people with cancer from severe COVID-19 infection, and we think this immune stimulator, IMM-101, may be able to do this.”
Laboratory tests have shown that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, such that if a patient is exposed to these types of infections their body may be able fight off the infection more effectively. This could help prevent severe symptoms from respiratory and COVID-19 related infections.
IMM-101 has already been studied in over 300 patients with cancer who have also been receiving other cancer treatments, including chemotherapy and radiation, and appears to be promising; however, it is not yet clear as to whether it can offer better results than not having the immunization at all.
"We know the immune systems of cancer patients are compromised both by their disease and the treatments they receive placing them at much higher risk of severe complications from COVID-19,” Christopher O'Callaghan, DVM, MSc, PhD, senior investigator at the CCTG who will be overseeing the national trial, said in a press release. “These patients are unable to practice social isolation due to the need to regularly attend hospital to receive critically important cancer treatment.”
The randomized, phase 3 trial of immunization with IMM-101 versus observation is anticipated to enroll 1500 participants. Patients in the experimental arm will receive one 1.0 mg/mL (= 0.1 mL) dose of IMM-101 given on day 0, followed by a second dose of 0.5 mg/mL (= 0.05 mL) of IMM-101 on day 14 (-2/+5 days), and a third dose of 0.5 mg/mL (= 0.05 mL) of IMM-101 on day 45 (+/-14 days). The observation arm will receive no other active treatment.
The primary outcome measure for the study is the rate of “flu-like illness,” which includes the WHO definition of "influenza-like illness" or confirmed viral/bacterial respiratory infection and results in a change or delay in cancer treatment or requirement for and unscheduled medical assessment, hospitalization or death.
The trial has already been approved by Health Canada and is anticipated to open at cancer centers across Canada this summer.
The Ottawa Hospital. Protecting cancer patients from COVID-19: World-first clinical trial tests a novel immune-boosting strategy. The Ottawa Hospital website. Published July 8, 2020. ohri.ca/newsroom/story/view/1256?l=en. Accessed July 13, 2020.