LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
NCT ID: NCT06623461
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
128 participants
INTERVENTIONAL
2025-04-07
2029-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard-of-care ICB
Assigned single agent or combination ICB treatment
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 for FMT + Standard-of-care ICB
Bowel preparation; LND101(single-dose); Assigned single agent or combination ICB treatment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 who have received antibiotics within 14 days of enrollment.
* Participants with systemic corticosteroid use \> 10mg per day.
* 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.
* Participants with leptomeningeal disease.
* Participants with any uncontrolled autoimmune disease that requires active immunosuppressive agents.
* Participants who are solid organ transplantation recipients.
* 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.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Cancer Society (CCS)
OTHER
Weston Family Foundation
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Arielle Elkrief
Role: STUDY_CHAIR
CHUM-Centre Hospitalier de ''Universite de Montreal, Montreal, QC Canada
John Lenehan
Role: STUDY_CHAIR
London Regional Cancer Program, London, ON Canada
Locations
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BCCA - Abbotsford
Abbotsford, 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
Countries
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Central Contacts
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Facility Contacts
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Jasna Deluce
Role: primary
Christopher Lee
Role: primary
Kerry J. Savage
Role: primary
Baskoro (Adi) Kartolo
Role: primary
John Lenehan
Role: primary
Shaqil Kassam
Role: primary
Michael Ong
Role: primary
Rossanna Pezo-Martin
Role: primary
Marcus Butler
Role: primary
Virginie Vallee-Guignard
Role: primary
Rahima Jamal
Role: primary
Wilson Miller
Role: primary
Chloe Beland
Role: primary
Anouk Tremblay
Role: primary
References
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Hadi DK, Baines KJ, Jabbarizadeh B, Miller WH, Jamal R, Ernst S, Logan D, Belanger K, Esfahani K, Elkrief A, Parvathy SN, Silverman MS, Routy B, Maleki Vareki S, Lenehan JG. Improved survival in advanced melanoma patients treated with fecal microbiota transplantation using healthy donor stool in combination with anti-PD1: final results of the MIMic phase 1 trial. J Immunother Cancer. 2025 Aug 4;13(8):e012659. doi: 10.1136/jitc-2025-012659.
Other Identifiers
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ME17
Identifier Type: -
Identifier Source: org_study_id
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