Recruiting
Phase 2

LND101 & FMT

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06623461

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Immune Checkpoint Blockade

LND101

Study Details

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

Study ID

NCT06623461

Start date

Apr 7, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard-of-care ICB

Assigned single agent or combination ICB treatment

experimental: LND101 for FMT + Standard-of-care ICB

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

Interventions

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.

Primary outcome measure

  • Progression-free Survival [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Janet Dancey

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

Locations

BCCA - Abbotsford

Recruiting

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

Contacts

Thao Nguyen

604 851-4707

BCCA - Surrey

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Christopher Lee

604 930-4017

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Kerry J. Savage

604 877-6000

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Baskoro (Adi) Kartolo

905 387-9495

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

John Lenehan

519 685-8640

Stronach Regional Health Centre at Southlake

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Shaqil Kassam

905 895-4521

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Michael Ong

613 737-7700

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rossanna Pezo-Martin

416 480-4757

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Marcus Butler

416 946-4501

Centre Integre de Sante et de Services Sociaux

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Contacts

Virginie Vallee-Guignard

450 466-5000

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Rahima Jamal

514 890-8444

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Wilson Miller

514 340-8222

Hotel-Dieu de Quebec

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Chloe Beland

418 525-4444

Centre hospitalier regional de Trois-Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Anouk Tremblay

819 697-3333

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

May 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-05-12.