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A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma
This study is being done to answer the following question: Can the chance of melanoma growing or spreading be lowered by receiving a treatment called LND101 for Fecal Microbiota Transplant (FMT) in addition to the usual immunotherapy treatment called Immune Checkpoint Blockade (ICB)? FMT treatment changes the bacteria in your gut called the microbiome.
We are doing this study because we want to find out if this approach (adding LND101 FMT to ICB) is better or worse than the usual approach (ICB only) for advanced melanoma. The usual approach is defined as care most people get for advanced melanoma. The usual approach for patients who are not in a study is treatment with immunotherapy drugs called immune checkpoint blockade (ICB) drugs. Immunotherapy works by activating the immune system to target the cancer. This may help to slow down the growth of cancer and may cause cancer cells to die.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
BCCA - Abbotsford
Abbotsford, British Columbia, Canada
BCCA - Surrey
Surrey, British Columbia, Canada
BCCA - Vancouver
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre Research Inc.
London, Ontario, Canada
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, Canada
Start Date
April 7, 2025
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2029
Last Updated
February 11, 2026
128
ESTIMATED participants
Standard of Care Immune Checkpoint Blockade
DRUG
LND101
DRUG
Lead Sponsor
Canadian Cancer Trials Group
Collaborators
NCT06066138
NCT05039801
Data Source & Attribution
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