Health TrialsbyHealthPanel

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

ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care Immune Checkpoint Blockade

    Drug

    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

    Drug

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Standard-of-care ICBActive comparator 1 intervention
Group B: LND101 for FMT + Standard-of-care ICBExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival

Time frame
4 years

Secondary outcomes

1

Overall Survival

Time frame
4 years
2

Objective Response Rate

Time frame
4 years
3

Number and severity of adverse events assessed with CTCAE version 5.0

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Cancer Society (CCS)

Collaborator

Weston Family Foundation

Collaborator

Source ClinicalTrials.gov
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