Testing LND101 for melanoma
Official title: LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma
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.
Canadian Sites (14)
BCCA - Abbotsford
Abbotsford British Columbia, 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
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Participants must have measurable disease as per RECIST 1.1/ iRECIST.
- +Participants must be at least 18 years of age.
- +The participant's standard-of-care ICB regimen must be selected prior to enrollment and must stay the same, regardless of armArmOne of the groups in a study, each receiving something different.Read more → assignment, post-enrollment
- +Participants must demonstrate adequate organ function Participants must be able to ingest capsules.
- +Participants must consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to provision of samples of blood and stool for correlative marker analysis.
- +Participants must consent to provision of, and investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Investigators must assure themselves the participants randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up.
- +ProtocolProtocolThe detailed plan a study must follow.Read more → ICB treatment must begin within 14 calendar days after participant enrollment.
- +Participants must have an ECOG performance status of 0, 1, or 2.
- +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.
Exclusion
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → and have no evidence of new or enlarging brain metastases; or
- −Participants with leptomeningeal disease.
- −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 living with HIV.
- −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −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.
- −asymptomatic or minimally symptomatic active metastases, with controlled steriod use and no imminent CNS complications.
- −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 with active infection. Participants may be eligible following recovery. Participants requiring antibiotics require 2-week washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → prior to enrollment.
- −Participants that are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more → Immune Checkpoint Blockade, LND101.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 128 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free Survival — measured over 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06623461 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4 years.
The study as a whole is currently expected to finish around 2029-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 128 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Abbotsford British Columbia, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.