Wednesday, July 15, 2020 The Canadian Cancer Trials Group (CCTG) and its network of investigators have responded to the pandemic through activation of and participation in three innovative clinical studies to ensure patients with cancer have access to cutting-edge treatments and supports. CCTG IC.8 COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19-Related Infections in Cancer Patients at Increased Risk of Exposure CCTG IC.8 is an innovative, world-leading clinical trial focused on strengthening the immune system of patients with cancer. The trial is investigating IMM-101, a preparation of safe, heat-killed bacteria that broadly stimulates the innate, or “first-response,” arm of the immune system. Dr. Rebecca Auer, surgical oncologist and Director of Cancer Research at The Ottawa Hospital and associate professor at the University of Ottawa, is the Study Chair and Dr. Chris O’Callaghan is the CCTG Senior Investigator leading the trial team. They hope that boosting cancer patients’ immune systems with IMM-101 will protect them from developing severe COVID-19 and other dangerous lung infections. In addition to support from the Canadian Cancer Society, the trial has a number of other partners, including, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, and Immodulon Therapeutics, the manufacturer of IMM-101. The trial was centrally activated on June 25, 2020 and is being conducted at 8 participating centres across Canada, including Ottawa (Dr. Auer), Odette Cancer Centre at Sunnybrook Health Sciences Centre (Dr. Martin Smoragiewicz, Princess Margaret Cancer Centre (Dr. Grainne O’Kane), Juravinski Cancer Centre at Hamilton Health Sciences (Dr. Rosalyn Juergens), London Regional Cancer Program (Dr. Eric Winquist), Cedars Cancer Centre, Montreal (Dr. George Zogopoulos), Centre Hospitalier de l’Université de Montréal (Dr. David Roberge), and Vancouver Cancer Centre (Dr. Jonathan Loree). https://www.ctg.queensu.ca/trials/symptom_control/ic8/ CCTG SC.27: Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of COVID-19 Pandemic on Cancer Patients During Treatment and Survivors The goal of CCTG SC.27 is to examine the impact of the COVID-19 pandemic on the experience of Canadian cancer patients at all stages of treatment, focussing on self-reported emotional, social and physical symptoms, quality of life, changes in cancer care, satisfaction with care, and use of a variety of positive and negative coping strategies. Drs Linda Carlson, University of Calgary, and Lynda Balneaves, University of Manitoba, with CCTG Senior Investigator, Dr. Harriet Richardson, are leading the study team. They will be looking at the unique challenges and potential benefits of these changes in care during the current pandemic by conducting a series of online surveys over a 12-month period asking cancer patients and survivors about their experiences, including people currently receiving cancer treatment and up to 10 years post-treatment. Participants will complete online surveys and investigators will interview cancer patients, survivors and their caregivers to better understand their experiences during the pandemic and how they have coped and adjusted to changes to their care. Investigators hope that the results of the trial will help to provide a better understanding of the nature of challenges encountered by cancer patients and that identifying potential solutions and developing appropriate supports that can be implemented and evaluated in future emergency planning and research will help to better support patients with cancer. The trial was centrally activated on June 30, 2020. https://www.ctg.queensu.ca/trials/symptom_control/sc27/ CCTG ICC.1/NCI COVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study CCTG ICC.1/NCI COVID-19 in Cancer Patients Study, or NCCAPS, is a natural history study of COVID-19 in people with cancer. In this study, researchers are following people and collecting medical and other information about them over time to learn more about how a disease and its symptoms develop and change. The knowledge gained through this study will help doctors better manage treatment for people with cancer and COVID-19 in the future. As part of the NCCAPS study, researchers will collect blood samples, medical information, and medical images from 2,000 people with cancer who also have COVID-19. Each person will be followed for up to 2 years to help doctors understand how cancer affects COVID-19 and COVID-19 affects cancer. The study is being led by the US National Institutes of Health (NIH) and CCTG activated the study on June 18, 2020. The Canadian Study Chair is Dr. Nathalie Daaboul at Hôpital Charles LeMoyne and Dr. Lois Shepherd is the CCTG Senior Investigator leading the trial in Canada. https://www.ctg.queensu.ca/trials/symptom_control/icc1/