Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623461
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None