LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma (NCT06623461)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (20 items).
Location: BCCA - Abbotsford — Abbotsford British Columbia, British Columbia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
- Participants that have received live attenuated vaccination administered within 30 days prior to randomization. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.
- For participants with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with absolute contraindications to FMT including: a) Toxic megacolon; b) Inflammatory bowel disease; c) Severe dietary allergies
- Participants with hypersensitivity to PegLyte®
- Participants with symptomatic brain metastases unless brain lesions are shown to be stable, according to the following definitions:
- without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases; or
- treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases; or
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (14 Sites)
- BCCA - Abbotsford — Abbotsford British Columbia, British Columbia
- BCCA - Surrey — Surrey, British Columbia
- BCCA - Vancouver — Vancouver, British Columbia
- Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario
- London Health Sciences Centre Research Inc. — London, Ontario
- Stronach Regional Health Centre at Southlake — Newmarket, Ontario
- Ottawa Hospital Research Institute — Ottawa, Ontario
- Odette Cancer Centre — Toronto, Ontario
- University Health Network — Toronto, Ontario
- Centre Integre de Sante et de Services Sociaux — Greenfield Park, Quebec
- CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec
- The Jewish General Hospital — Montreal, Quebec
- Hotel-Dieu de Quebec — Québec, Quebec
- Centre hospitalier regional de Trois-Rivieres — Trois-Rivières, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.