The innovative ME17 melanoma trial has opened to enrollment

Above: Dr. Rahima Jamal and Camille Amiel prepare the patient to take the fecal microbiota capsules. Photo: Centre hospitalier de l’Université de Montréal (CHUM)

français: La période d’inscription à l’essai novateur sur le mélanome ME17 est commencée.

One of the world’s largest randomized clinical trials, investigating the use of fecal microbiota transplantation (FMT) has opened in Canada. The ME17 (Canbiome2) study will look at the effects of adding FMT to the standard immune checkpoint blockade (ICB) treatment to improve outcomes for advanced melanoma patients.

“We aim to use FMT to safely change melanoma patients’ gut microbiota, which we believe will improve the benefit of immunotherapy,” says Dr. Arielle Elkrief, ME17 study co-chair, Clinician-Scientist, Université de Montréal-affiliated hospital research centre (CRCHUM). 

ICB is the current standard of care however many patients will still experience disease progression. The study will use an encapsulated stool sample from healthy donors to change patients’ gut microbiota with the intent of making the current treatment for advanced melanoma more effective. 

“This study builds on our experience with 2 early-phase studies that demonstrated the safety of this approach and suggested outcomes may be improved for patients with advanced melanoma,” says Dr. John Lenehan, ME17 study co-chair, and Medical Oncologist, London Health Sciences Centre Research Institute (LHSCRI).

Researchers aim to have 130 Canadian patients participating in this study. Finding a path to make this treatment effective for more people would have huge impact on patient care and significantly improve the odds of surviving advanced melanoma. "The first Canadian patients to receive this new treatment will have access to the potential of improved treatment, survivability, and quality of life not just for themselves but for people who will be diagnosed with advanced melanoma in the future," says Sally Nystrom, CCTG Patient Representative.

The ME17 (Canbiome2) trial brings together a collaboration of key researchers from Montreal led by Dr. Elkrief and Dr. Routy (CRCHUM), and London led by Dr. Lenehan and Dr. Maleki (LHSCRI). The healthy donor capsule manufacturing is performed by Drs Silverman and Maleki’s healthy donor screening program (St Josephs Health Care). The trial is made possible through grants from the Canadian Institutes of Health Research, the Canadian Cancer Society and the Weston Family Foundation.

“Microbiome interventions have shown great promise in several early-phase oncology trials pioneered by our group. We hope to have a definitive signal from this randomized trial in melanoma to further advance the field and help patients," says Dr. Saman Maleki, Translational Scientist, London Health Sciences Centre Research Institute (LHSCRI). “We are excited to delve deeper into the mechanism of action and uncover donor-host compatibility by studying the samples from this trial," affirms Dr. Bertrand Routy, Clinician-Scientist and Associate Professor, Université de Montréal-affiliated hospital research centre (CRCHUM).

• ME17 patient information >
• ME17 members trial information >