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New treatment option for Melanoma
Official title LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
ClinicalTrials.gov ID: NCT06623461
What this study is testing
What is LND101?
LND101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Prior targeted therapy with BRAF/MEK inhibition in the adjuvant or advanced / metastatic setting is permitted if at least 2 weeks have elapsed...
- Prior radiation therapy is permitted if at least 7 days have elapsed between the last fraction and study enrollment. Participants must have recovered...
You likely can't join if
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it...
- 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...
- For participants with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if...
See the full eligibility criteria
Who can 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...
- 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...
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants assigned by chance on this trial will be available for complete documentation of the treatment, adverse...
- 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.
What rules you out
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Abbotsford British Columbia, British Columbia, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Greenfield Park, Quebec, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Trois-Rivières, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.