Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-31 @ 1:38 PM
Study NCT ID:
NCT06807593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.
Detailed Description:
Primary Objectives:
To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis
To assess the efficacy of ustekinumab in reducing fecal calprotectin levels
Secondary Objectives:
To assess steroid free IMDC remission by week 4 and 8
To assess the IMDC recurrence by week 4 and 8
To assess the time duration to IMDC recurrence and overall survival
To assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis
To identify immune signatures related to GI irAEs and those specific to responsiveness to ustekinumab
To identify pro-inflammatory immune signatures in serum
To assess patient symptom and QOL
To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis
To assess the efficacy of ustekinumab in reducing fecal calprotectin levels
Secondary Objectives:
To assess steroid free IMDC remission by week 4 and 8
To assess the IMDC recurrence by week 4 and 8
To assess the time duration to IMDC recurrence and overall survival
To assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis
To identify immune signatures related to GI irAEs and those specific to responsiveness to ustekinumab
To identify pro-inflammatory immune signatures in serum
To assess patient symptom and QOL
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00795 | OTHER | NCI-CTRP Clinical Trials Registry | View |