Actively Recruiting
LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
128
Participants Needed
14
Research Sites
247 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cutaneous melanoma or melanoma of unknown primary
- Stage IV or advanced unresectable melanoma
- No prior immune checkpoint blockade treatment for advanced disease
- Prior ICB in adjuvant or neoadjuvant setting allowed if last dose was at least 6 months before enrollment
- Prior targeted BRAF/MEK therapy allowed if at least 2 weeks since last dose and recovered to grade 1 or less toxicity
- Prior radiation therapy allowed if at least 7 days since last treatment and recovered to grade 1 or less toxicity
- Major surgery allowed if at least 14 days before enrollment with healed wound
- Must have measurable disease per RECIST 1.1 or iRECIST
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Standard-of-care ICB regimen selected before enrollment and unchanged post-enrollment
- Adequate organ function and able to swallow capsules
- Consent to provide blood and stool samples for analysis
- Consent and ability to provide archival tumor tissue if available
- Access to provincially-funded standard-of-care ICB treatment
- Ability to provide informed consent
- Available for treatment and follow-up
- Protocol ICB treatment must start within 14 days after enrollment
- Use of highly effective contraception if of childbearing potential
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Antibiotic use within 14 days before enrollment
- Systemic prednisone use greater than 10 mg per day or equivalent
- Concurrent treatment with other anti-cancer therapies
- Live attenuated vaccine within 30 days before randomization (inactivated influenza and COVID-19 vaccines allowed)
- Active or uncontrolled chronic hepatitis B or untreated hepatitis C infection
- Contraindications to fecal microbiota transplant such as toxic megacolon, inflammatory bowel disease, severe dietary allergies
- Hypersensitivity to PegLyte�
- Symptomatic brain metastases unless stable or treated and no progression
- Leptomeningeal disease
- Uncontrolled autoimmune disease requiring immunosuppressive agents
- Solid organ transplant recipients or expected transplant
- Living with HIV
- Active infection requiring antibiotics without 2-week washout
- Pregnant, breastfeeding, or planning to conceive or father children during the trial
AI-Screening
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Trial Site Locations
Total: 14 locations
1
BCCA - Abbotsford
Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
Actively Recruiting
2
BCCA - Surrey
Surrey, British Columbia, Canada, V3V 1Z2
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
5
London Health Sciences Centre Research Inc.
London, Ontario, Canada, N6A 5W9
Actively Recruiting
6
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
Actively Recruiting
7
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
8
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
9
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
Centre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, Canada, J4V 2H1
Actively Recruiting
11
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
12
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
13
Hotel-Dieu de Quebec
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
14
Centre hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
Research Team
J
Janet Dancey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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