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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.