At a glance
ClinicalIndex Comparison Record- ✓Confirmed histological diagnosis of cutaneous melanoma or melanoma of unknown primary
- ✓Stage IV or advanced unresectable disease
- ✓No prior ICB for advanced/metastatic disease (adjuvant/neoadjuvant allowed if ≥6 months prior)
- ✓Measurable disease per RECIST 1.1/iRECIST
- ✕Prior or concurrent malignancy with potential to interfere with safety or efficacy assessment
- ✕Antibiotics within 14 days of enrollment
- ✕Systemic prednisone >10mg per day or equivalent
- ✕Concurrent anti-cancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma
In Brief
A Phase 2 clinical trial evaluating Standard of Care Immune Checkpoint Blockade and LND101 for Melanoma. Currently recruiting, targeting 128 participants across 14 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
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.