Viewing Study NCT06499896



Ignite Creation Date: 2024-07-17 @ 11:10 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06499896
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-15
First Post: 2024-07-01

Brief Title: Healthy-donor Microbiome MTP-101-C in Steroid Relapserefractory Immune-related Cutaneous Adverse Events irCAEs and Immune-mediated Colitis IMC
Sponsor: Diwakar Davar
Organization: University of Pittsburgh

Study Overview

Official Title: Phase II Trial of Healthy-donor Derived Full-spectrum Microbiome Therapeutic MTP-101-C in Steroid Relapserefractory Immune-related Cutaneous Adverse Events irCAEs and Immune-mediated Colitis IMC FMT-ELIMINATE
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
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: FMT-ELIMINATE
Brief Summary: Multiple retrospective studies suggest that the administration of corticosteroids to treat irAEs is safe and does not compromise efficacy of ICI therapy in cancer patients While 67 of patients respond to corticosteroids 33 of patients require biologic therapy such as TNFα inhibitors eg infliximab integrin α4β7 inhibitors eg vedolizumab or JAKSTAT inhibitors eg tofactinib This study aims to determine that distinct pathobionts govern the development of irCAE and IMC and that the administration of hdFMT may reverse steroid-refractory irCAEs or IMC The use of hdFMT has been shown to be effective in steroid and biologic TNFα andor integrin α₄β₇ inhibitor refractory colitis in PD-1 andor CTLA-4 ICI treated cancer patients in single-institution case series
Detailed Description: The study will be conducted over a 42-day period Patients receiving anti-PDL1 andor anti-CTLA-4 singly or in combination with other investigational agents are eligible to enroll Enrollment is not limited by setting adjuvant metastatic andor line of therapy 1L 2L etc Once enrolled patients will be enrolled to receive MTP-101-C encapsulated fecal microbiota containing 5 x 1011 bacteria derived from healthy donors without prior antibiotic conditioning MTP-101-C will be continued for 28 days during which steroids will be tapered rapidly irAE endpoint assessment will be repeated following completion of hdFMT D28 to D35 and at 6 weeks D42 to D49 Biospecimens will be obtained periodically The total duration of MTP-101-C therapy is 4 weeks This study aims to determine distinct pathobionts govern the development of distinct irAEs including steroid-refractory irCAE or IMC and that the administration of hdFMT ameliorates irCAE or IMC based on validated cohort-specific assessments modified CTCAE grading system cohort 1 or endoscopic assessment scale full Mayo score FMS cohort 2 Further this trial aims to show that amelioration of inflammatory pathology is associated with key secondary objectives including 1 improvements in an irAE toxicity-specific PRO FACT-ICM and 2 clinically assessment scales Also this study will measure the correlation between symptom amelioration and changes in integrated biomarkers include measures of intestinal inflammation fecal calprotectin bacterial engraftment metagenomic and reactivity to donor bacteria IgG-seq exploring the effects of microbiome modulation upon time to steroid discontinuation time to resumption of therapy time to next treatment clinical remission by FMS clinical remission by PMS and key survival endpoints

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
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?: None