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

NCT06623461 | Recruiting Phase 2 DMC

• 1 other identifier: ME17
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  4 years

Secondary Outcomes (3)

• Overall Survival

  4 years

• Objective Response Rate

  4 years

• Number and severity of adverse events assessed with CTCAE version 5.0

  4 years

Study Arms (2)

Standard-of-care ICB

ACTIVE COMPARATOR

Assigned single agent or combination ICB treatment

Drug: Standard of Care Immune Checkpoint Blockade

LND101 for FMT + Standard-of-care ICB

EXPERIMENTAL

Bowel preparation; LND101(single-dose); Assigned single agent or combination ICB treatment.

Drug: Standard of Care Immune Checkpoint Blockade; Drug: LND101

Interventions

Standard of Care Immune Checkpoint Blockade DRUG

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; Standard-of-care ICB

LND101 DRUG

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.

LND101 for FMT + Standard-of-care ICB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Weston Family Foundation: collaborator

Study Sites (14)

BCCA - Abbotsford

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

RECRUITING

BCCA - Surrey

Surrey, British Columbia, V3V 1Z2, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Centre Integre de Sante et de Services Sociaux

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, G8Z 3R9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40759441 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Arielle Elkrief

  CHUM-Centre Hospitalier de ''Universite de Montreal, Montreal, QC Canada

  STUDY CHAIR

• John Lenehan

  London Regional Cancer Program, London, ON Canada

  STUDY CHAIR

Central Study Contacts

Janet Dancey

CONTACT

613-533-6430; jdancey@ctg.queensu.cca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)