Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-03 @ 4:37 AM
Study NCT ID:
NCT06623461
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2024-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
Sponsor:
Canadian Cancer Trials Group
Organization:
Study Overview
Official Title:
A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Canbiome2
Brief Summary:
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.
Detailed Description:
We are doing this study because we want to find out if this approach (adding LND101 FMT to ICB) is better or worse than the usual approach (ICB only) for advanced melanoma. The usual approach is defined as care most people get for advanced melanoma.
The usual approach for patients who are not in a study is treatment with immunotherapy drugs called immune checkpoint blockade (ICB) drugs. Immunotherapy works by activating the immune system to target the cancer. This may help to slow down the growth of cancer and may cause cancer cells to die.
The usual approach for patients who are not in a study is treatment with immunotherapy drugs called immune checkpoint blockade (ICB) drugs. Immunotherapy works by activating the immune system to target the cancer. This may help to slow down the growth of cancer and may cause cancer cells to die.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: