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

PHASE2RecruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Melanoma
Interventions
DRUG

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

DRUG

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.

Trial Locations (11)

V2S 0C2

RECRUITING

BCCA - Abbotsford, Abbotsford

V5Z 4E6

RECRUITING

BCCA - Vancouver, Vancouver

L8V 5C2

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton

N6A 5W9

RECRUITING

London Health Sciences Centre Research Inc., London

K1H 8L6

RECRUITING

Ottawa Hospital Research Institute, Ottawa

M4N 3M5

RECRUITING

Odette Cancer Centre, Toronto

M5G 2M9

RECRUITING

University Health Network, Toronto

H2X 3E4

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal

H3T 1E2

RECRUITING

The Jewish General Hospital, Montreal

G1R 2J6

RECRUITING

Hotel-Dieu de Quebec, Québec

G8Z 3R9

RECRUITING

Centre hospitalier regional de Trois-Rivieres, Trois-Rivières

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Canadian Cancer Society (CCS)

OTHER

collaborator

Weston Family Foundation

OTHER

lead

Canadian Cancer Trials Group

NETWORK