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The Canadian Cancer Society (CCS) is uniting with a team of 12 researchers and collaborators to lead one of the world’s largest randomized controlled clinical trials using fecal microbiota transplantation (FMT) to improve the effectiveness of the standard of care for advanced melanoma. This phase II trial is made possible by investments of $1 million each from CCS and the Weston Family Foundation and will be overseen by the Canadian Cancer Trials Group. 

An estimated 11,300 Canadians are expected to be diagnosed with melanoma in 2024. The current standard of care for patients with advanced melanoma is a type of immunotherapy called immune checkpoint blockade (ICB) and while it plays an important role in treatment, more than half of patients will still experience disease progression and unfortunately die of the disease. Finding a path to make this treatment effective for more people would have enormous impact on patient care and significantly improve the odds of surviving advanced melanoma. 

The funding from CCS and the Weston Family Foundation supports all translational research and part of the trial costs (study ME17). The study is being co-led by researchers from Université de Montréal's affiliated hospital research centre (CRCHUM) and Lawson Health Research Institute, alongside collaborators and close to 130 patients with advanced melanoma who will be recruited throughout Canada to participate in this study.

The phase II trial builds on previous research that also received funding support from CCS. Those studies showed the safety and therapeutic potential of using healthy donors’ stool to influence a patient’s gut microbiota and make treatment for advanced melanoma more effective. The study will administer fecal microbiota transplants using specially-prepared oral capsules produced and pioneered at Lawson Health Research Institute, which have been a game changer in patient acceptance and ease of use.

For the past five years, the Weston Family Foundation has supported Canadian researchers working to leverage the microbiome to improve cancer diagnostics, therapy and patient care. 

The biggest and most critical issues related to cancer, such as improving treatment effectiveness for people living with melanoma, are issues that require collaboration. From researchers to clinical trial leaders, to academic and scientific institutions, to caring funders and generous donors, it takes a society to transform cancer. To support cancer research and clinical trials, visit cancer.ca.

Quotes

“What saved me was trusting the scientists who knew what they were doing and the promising results of the clinical trial. To someone who is diagnosed, I would say that if you are offered this treatment, it may sound strange, but it is to help you. Thank you to the partners and the CRCHUM team for their support and for the treatments that went wonderfully well and saved my life." - Louise-Hélène Giroux, diagnosed in 2021 with stage 4 melanoma, first patient in the phase I clinical trial in Quebec to try FMT treatment 

“Because of the generosity of our donors, we are able to invest in world-leading cancer research and clinical trials like this trial focused on advanced melanoma. In 2020, together with the Lotte and John Hecht Memorial Foundation, we committed nearly $1.5M into this research through an Impact Grant. Today, we are joining with the Weston Family Foundation to double down on our original investment through this clinical trial because we believe this work will transform the future of melanoma, saving lives and bringing hope to thousands of people facing the disease every year in this country.” – Dr. Stuart Edmonds, Executive Vice President, Mission, Research and Advocacy, Canadian Cancer Society

“The Weston Family Foundation is thrilled to support this pioneering research into the role of the microbiome in the fight against cancer, which has real potential to transform treatments and care for this devastating disease. It's a bold step forward in our mission to invest in innovation that delivers measurable impacts to the well-being of Canadians. Working alongside forward-thinking researchers and partners like the Canadian Cancer Society will make way for advancements that help to bring hope to patients and families affected by melanoma.” – Garfield Mitchell, Chair, Weston Family Foundation  

 “We are aiming to safely change the patient’s gut microbiota to improve the benefit of immunotherapy in several cancers, including melanoma. This experimental treatment consists of transplanting stool from healthy donors using a Health Canada-approved process - known as fecal microbiota transplantation (FMT). With this investment, we can pursue our randomized trial, with the goal of improving the lives of patients with advanced melanoma. We are optimistic that we will see promising results.” – Dr. Arielle Elkrief, principal investigator, Clinician-Scientist, Université de Montréal-affiliated hospital research centre (CRCHUM)

“Our early research has shown the safety of combining FMT with immunotherapy and that it may improve outcomes for patients with melanoma. Through this new trial, we hope to demonstrate that the combination is more effective than immunotherapy alone. A positive result would lead to a phase III trial with the potential to make FMT with immunotherapy the new standard of care.” - Dr. John Lenehan, Medical Oncologist at the Verspeeten Family Cancer Centre at London Health Sciences Centre and Associate Scientist at Lawson Health Research Institute, Co-chair of ME17 trial

The researchers and collaborators

The phase II clinical trial, known as the ME17 Fecal microbiota transplantation (FMT) in combination with immune checkpoint blockade in patients with advanced melanoma: A randomized phase II trial, involves several highly collaborative experts who will be working with the Canadian Cancer Trials Group (CCTG) who will administer the trial nationally. For the translational research associated with the trial, the project team includes: 

Co-Principal Investigators:
Dr. Janet Dancey, Medical Oncologist and Professor, Queen’s University, Director of the Canadian Cancer Trials Group  
Dr. Arielle Elkrief, Clinician-Scientist and Assistant Professor, Université de Montréal-affiliated hospital research centre (CRCHUM)
Dr. John Lenehan, Medical Oncologist at LHSC’s Verspeeten Family Cancer Centre, Associate Scientist, Lawson Health Research Institute 
Dr. Bertrand Routy, Clinician-Scientist and Associate Professor, Université de Montréal-affiliated hospital research centre (CRCHUM)
Dr. Saman Maleki, Scientist, Lawson Health Research Institute, London Health Sciences Centre's (LHSC) Verspeeten Family Cancer Centre and Ontario Institute of Cancer Research (OICR) 
Dr. Michael Silverman, Scientist, Lawson Health Research Institute, Medical Director of the Infectious Disease Care Program at St. Joseph’s Health Care London 
 
Collaborators:
Dr. Seema Parvathy, Lawson Health Research Institute
Dr. Marcus Butler, Leader of the CCTG Melanoma Disease Site Committee, Princess Margaret Cancer Center
Dr. Rahima Jamal, hemato-oncologist, researcher and medical director at the Unit for Innovative Therapies (Phase I-II Unit), Université de Montréal-affiliated hospital research centre (CRCHUM)
Dr. Ian Watson, Associate Professor and Co-chair CCTG Melanoma Disease Committee, McGill University
Dr. Bingshu Chen, Professor, Queen’s University
Dr. Meriem Messaoudene, Research Associate, Université de Montréal-affiliated hospital research centre (CRCHUM)

About the Canadian Cancer Society
The Canadian Cancer Society works tirelessly to save and improve lives. We raise funds to fuel the brightest minds in cancer research. We provide a compassionate support system for all those affected by cancer, across Canada and for all types of cancer. Together with patients, supporters, donors and volunteers, we work to create a healthier future for everyone. Because to take on cancer, it takes all of us. It takes a society. Help us make a difference. Call 1-888-939-3333 or visit cancer.ca today.

About the Weston Family Foundation
At the Weston Family Foundation (formerly The W. Garfield Weston Foundation), more than 60 years of philanthropy have taught us that there’s a relationship between healthy landscapes and healthy people. That’s why we champion world-class health research and innovation with the same passion that we support initiatives to protect and restore biodiversity on our unique landscapes. We take a collaborative approach to philanthropy, working alongside forward-thinking partners to advance Canada and create lasting impacts. We aspire to do more than provide funding; we want to enable others to find transformational ways to improve the well-being of Canadians.

Researchers at Western University and Lawson Health Research Institute continue to make important contributions to help mitigate the spread of COVID-19 and its negative consequences. Two projects in London will address virus transmission during surgery and pandemic planning for COVID-19, thanks to new funding announced by the Government of Canada, through the Canadian Institutes of Health Research (CIHR), along with provincial partners.

Researchers in London received more than $400,000 in funding through this latest round.

“Accelerating high-quality research and real-time evidence is a priority for Canada in its fight against COVID-19. I congratulate the successful teams for their essential work aimed at better preventing, detecting and treating COVID-19 at the individual and population levels,” said Patty Hajdu, Minister of Health in a press release. “Our government believes that it’s through collaboration and data sharing that we will respond efficiently to this global health emergency.” 

Virus transmission in surgical smoke

In an effort to perform surgery during the pandemic as effectively and safely as possible, Dr. Leigh Sowerby, Associate Professor at Schulich Medicine & Dentistry and Associate Scientist at Lawson, will be investigating whether or not the virus that causes COVID-19 can be transmitted in surgical smoke. Surgical smoke is the aerosol produced by an essential surgical tool called electrocautery. 

“Electrocautery is a ubiquitous tool for surgery, and is known to generate aerosol and smoke. We do not know if the SARS-CoV-2 virus can be transmitted in this plume, and this is important to answer for all surgeons, but in particular, for surgeons working in the respiratory and aerodigestive tract,” said Dr. Sowerby, who is also a head and neck surgeon at London Health Sciences Centre and St. Joseph’s Health Care London. “CIHR funding will allow us to rapidly execute this project. Without this funding, the project would not be possible.”

Dr. Sowerby says the results from this study, whether positive or negative, will have important implications. If positive, it will have a critical and direct impact on ensuring the safety of health care workers performing procedures on patients. Procedures using cautery will continue to require high level protection if the COVID-19 status of the patient is unknown. If negative, it will allow these surgical procedures to continue safely and effectively while conserving critical protective equipment for cases that need it.

The family physician’s role in pandemic plans

Maria Mathews, PhD, Associate Professor at Schulich Medicine & Dentistry, is investigating how the role of family physicians can be better incorporated into pandemic plans. Family physicians play important roles during a pandemic, from detecting potential outbreaks and screening and testing patients to providing care to infected patients and contributing to surge capacity in hospitals. 

“During the early stages of the COVID-19 pandemic, family physicians had concerns about roles they were asked to fill for a variety of reasons, including the lack of appropriate personal protective equipment, availability of tests, and concerns about infection risks to other patients and staff in a family practice clinic,” said Mathews.

Mathews will examine the experiences in four regions in Canada – Newfoundland and Labrador, Nova Scotia, Ontario and British Columbia – to identify key roles, supports and best practices. The results will provide government ministries, public health units, and other health organizations with evidence and tools in order to incorporate family physicians in the response to a potential second COVID-19 wave and plan for future pandemics.