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Clinical Trials in Canada / NCT06623461
Recruiting Phase 2

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

NCT06623461 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2025-04-07
Last updated
2026-09-15

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Standard of Care Immune Checkpoint BlockadeLND101

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

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * Prior radiation therapy is permitted if at least 7 days have elapsed between the last fraction and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to prior radiotherapy. * Previous major surgery is permitted provided that surgery occurred ≥ 14 days prior to participant enrollment and that wound healing has occurred. * Participants must have measurable disease as per RECIST 1.1/ iRECIST. * Participants must be at least 18 years of age. * Participants must have an ECOG performance status of 0, 1, or 2. * The participant's standard-of-care ICB regimen must be selected prior to enrollment and must stay the same, regardless of arm assignment, post-enrollment * Participants must demonstrate adequate organ function Participants must be able to ingest capsules. * Participants must consent to provision of samples of blood and stool for correlative marker analysis. * Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available. * Participants must have access to provincially-funded standard-of-care ICB treatment. * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Protocol ICB treatment must begin within 14 calendar days after participant enrollment. * Participants of childbearing potential must have agreed to use a highly effective contraceptive method. 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: 1. without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases; or 2. treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases; or 3. treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases. 4. asymptomatic or minimally symptomatic active metastases, with controlled steriod use and no imminent CNS complications. * Participants with leptomeningeal disease. * Participants with any uncontrolled autoimmune disease that requires active immunosuppressive agents. * Participants who are solid organ transplantation recipients or likely to receive solid organ transplants in the future. * Participants living with HIV. * Participants with active infection. Participants may be eligible following recovery. Participants requiring antibiotics require 2-week washout period prior to enrollment. * Participants that are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
BCCA - Abbotsford Abbotsford British Columbia British Columbia Recruiting
BCCA - Surrey Surrey British Columbia Recruiting
BCCA - Vancouver Vancouver British Columbia Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario Recruiting
London Health Sciences Centre Research Inc. London Ontario Recruiting
Stronach Regional Health Centre at Southlake Newmarket Ontario Recruiting
Ottawa Hospital Research Institute Ottawa Ontario Recruiting
Odette Cancer Centre Toronto Ontario Recruiting
University Health Network Toronto Ontario Recruiting
Centre Integre de Sante et de Services Sociaux Greenfield Park Quebec Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal Montreal Quebec Recruiting
The Jewish General Hospital Montreal Quebec Recruiting
The Research Institute of the McGill University Montreal Quebec Recruiting
Hotel-Dieu de Quebec Québec Quebec Recruiting
Centre hospitalier regional de Trois-Rivieres Trois-Rivières Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06623461 on ClinicalTrials.gov ↗ ← All trials in Canada