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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Any ICB (single agent or combination) may be used that is commercially available, Health Canada-approved and publically funded for the treatment of participants with advanced, unresectable or metastatic melanoma. The treatment decision for choice of ICB regimen will be made prior to randomization and cannot be changed after enrollment
Approximately 40 capsules (total of 80-100g of processed fecal material) taken by mouth 7 days prior to the ICG agent(s) administered following bowel preparation.
BCCA - Abbotsford
Abbotsford British Columbia, British Columbia, Canada
RECRUITINGBCCA - Surrey
Surrey, British Columbia, Canada
Progression-free Survival
Time frame: 4 years
Overall Survival
Time frame: 4 years
Objective Response Rate
Time frame: 4 years
Number and severity of adverse events assessed with CTCAE version 5.0
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BCCA - Vancouver
Vancouver, British Columbia, Canada
RECRUITINGJuravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
RECRUITINGLondon Health Sciences Centre Research Inc.
London, Ontario, Canada
RECRUITINGStronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada
RECRUITINGOttawa Hospital Research Institute
Ottawa, Ontario, Canada
RECRUITINGOdette Cancer Centre
Toronto, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITINGCentre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, Canada
RECRUITING...and 5 more locations