NCT06623461

LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma

A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Standard of Care Immune Checkpoint Blockade	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
DRUG	LND101	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.

Timeline

• Start date: 2025-04-07
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-10-02
• Last updated: 2026-03-27

Locations

14 sites across 1 country: Canada