Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551272
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
MOTHER
Brief Summary:
Hepatocellular carcinoma HCC is the most common liver primary cancer with a high rate of mortality Since the results of IMbrave150 immunotherapy have emerged as a standard of care for HCC patients advanced andor unresectable in first line of treatment The objective response rate was about 30 but half of patients would present only stable disease and about 20 progressive disease
Faecalibacterium prausnitzii is one of the most abundant bacterial in human gut microbiota around 5 of total bacteria in feces
For patients with metastatic melanoma treated with ipilimumab an antibody targeting CTLA-4 Cytotoxic T-lymphocyte-associated antigen 4 patients with a baseline gut microbiota enriched with Faecalibacterium had a significantly better clinical outcomes In patients with metastatic melanoma the level of Faecalibacterium prausnitzi at baseline was predictive of response to anti-PD-1 programmed death-1 or anti-CTLA-4 therapy EXL01 is a pharmacological preparation of Faecalibacterium prausnitzii strains Preclinical murine study suggests that the administration of EXL01 could reverse the resistance to ICI induced by antibiotics unpublished data
We thus plan to test the concept of microbiota modification in patients treated with atezolizumab-bevacizumab for advanced HCC We would include patients refractory to first-line treatment and test the addition of EXL01 to atezolizumab-bevacizumab in order to reverse resistance
Faecalibacterium prausnitzii is one of the most abundant bacterial in human gut microbiota around 5 of total bacteria in feces
For patients with metastatic melanoma treated with ipilimumab an antibody targeting CTLA-4 Cytotoxic T-lymphocyte-associated antigen 4 patients with a baseline gut microbiota enriched with Faecalibacterium had a significantly better clinical outcomes In patients with metastatic melanoma the level of Faecalibacterium prausnitzi at baseline was predictive of response to anti-PD-1 programmed death-1 or anti-CTLA-4 therapy EXL01 is a pharmacological preparation of Faecalibacterium prausnitzii strains Preclinical murine study suggests that the administration of EXL01 could reverse the resistance to ICI induced by antibiotics unpublished data
We thus plan to test the concept of microbiota modification in patients treated with atezolizumab-bevacizumab for advanced HCC We would include patients refractory to first-line treatment and test the addition of EXL01 to atezolizumab-bevacizumab in order to reverse resistance
Detailed Description:
None
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