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.
Participants must have a confirmed histological diagnosis of cutaneous melanoma or melanoma of unknown primary.
Participants must have stage IV or advanced unresectable disease.
No prior ICB treatment for advanced unresectable or metastatic disease. Participants may have received adjuvant or neoadjuvant ICB if last dose was given ≥ 6 months prior to enrollment
Prior targeted therapy with BRAF/MEK inhibition in the adjuvant or advanced / metastatic setting is permitted if at least 2 weeks have elapsed between the last dose and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to BRAF/MEK inhibition
Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Participants who have received antibiotics within 14 days of enrollment.
Participants with systemic prednisone use > 10mg per day or equivalent dose.
Participants with concurrent treatment with other anti-cancer therapy.
Canadian Cancer Trials Group
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Canadian Cancer Society (CCS)
Collaborator
Weston Family Foundation
Collaborator