RecruitingPhase 2NCT06623461

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


Sponsor

Canadian Cancer Trials Group

Enrollment

128 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a fecal microbiota transplant (FMT) — transferring gut bacteria from a healthy donor — alongside standard immunotherapy can improve outcomes for people with advanced melanoma (skin cancer) that has spread and cannot be surgically removed. Researchers believe the gut microbiome may affect how well immunotherapy works. **You may be eligible if...** - You have been diagnosed with stage IV or unresectable advanced cutaneous melanoma or melanoma of unknown origin - You have not previously received immunotherapy (immune checkpoint blockers, or ICB) for advanced disease - If you received prior ICB as adjuvant/preventive therapy, your last dose was at least 6 months ago - Prior targeted therapy (BRAF/MEK inhibitors) is allowed if it ended at least 2 weeks before joining the study **You may NOT be eligible if...** - You have already received immunotherapy for advanced or metastatic melanoma - You have serious autoimmune conditions - You recently completed targeted therapy and side effects have not resolved Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGStandard 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

DRUGLND101

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.


Locations(14)

BCCA - Abbotsford

Abbotsford British Columbia, 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

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06623461


Related Trials