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MelanomaPhase 2Canbiome2NCT06623461

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

A Phase 2 study testing LND101 in people with Melanoma, run by Canadian Cancer Trials Group at 15 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
LND101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
15 sitesCanada
Study dates
7 Apr 2025to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janet Dancey contact

613-533-6430

jdancey@ctg.queensu.cca

15 sites in 1 country

Canada15 sites, 15 recruiting

  • BCCA - Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2

    Thao Nguyen, 604 851-4707

    Recruiting

  • Centre Integre de Sante et de Services Sociaux

    Greenfield Park, Quebec, J4V 2H1

    Virginie Vallee-Guignard, 450 466-5000

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Baskoro (Adi) Kartolo, 905 387-9495

    Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

    John Lenehan, 519 685-8640

    Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Rahima Jamal, 514 890-8444

    Recruiting

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Wilson Miller, 514 340-8222 ext. 4365

    Recruiting

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

    Catalin Mihalcioiu, 514 934-1934

    Recruiting

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

    Shaqil Kassam, 905 895-4521

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Michael Ong, 613 737-7700 ext. 75051

    Recruiting

  • Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

    Chloe Beland, 418 525-4444 ext. 67322

    Recruiting

  • BCCA - Surrey

    Surrey, British Columbia, V3V 1Z2

    Christopher Lee, 604 930-4017

    Recruiting

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

    Rossanna Pezo-Martin, 416 480-4757

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Marcus Butler, 416 946-4501 ext. 5485

    Recruiting

  • Centre hospitalier regional de Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9

    Anouk Tremblay, 819 697-3333 ext. 63337

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Kerry J. Savage, 604 877-6000 ext. 2641

    Recruiting

Other trials in Canada

About this study

Official title: A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma

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.

Read the detailed description

We are doing this study because we want to find out if this approach (adding LND101 FMT to ICB) is better or worse than the usual approach (ICB only) for advanced melanoma. The usual approach is defined as care most people get for advanced melanoma.

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
Melanoma
Being tested
Standard of Care Immune Checkpoint Blockade, LND101
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care Immune Checkpoint BlockadeDrug

    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

  • LND101Drug

    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 groups in NCT06623461
Study groupRoleWhat they receive
Standard-of-care ICBActive comparatorAssigned single agent or combination ICB treatment
Receives: Drug: Standard of Care Immune Checkpoint Blockade
LND101 for FMT + Standard-of-care ICBExperimentalBowel preparation; LND101(single-dose); Assigned single agent or combination ICB treatment.
Receives: Drug: Standard of Care Immune Checkpoint Blockade; Drug: LND101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Measured: 4 years

Secondary outcomes (3)

  1. Overall Survival

    Measured: 4 years

  2. Objective Response Rate

    Measured: 4 years

  3. Number and severity of adverse events assessed with CTCAE version 5.0

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start7 Apr 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623461
Sponsor's protocol ID
ME17
Acronym
Canbiome2
Status last verified
Feb 2026
First submitted
30 Sep 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40759441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LND101 in people with Melanoma, run by Canadian Cancer Trials Group at 15 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janet Dancey (613-533-6430, jdancey@ctg.queensu.cca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06623461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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