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NCT05462496 · ClinicalTrials.gov registry record · Phase 2
Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05462496: Recruiting Phase 2 study of Pancreatic Cancer, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05462496 is a Phase 2 study of Pancreatic Cancer that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 25 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05462496, a Phase 2 study of Pancreatic Cancer, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
Primary Outcome
Achievement of overall immune response, defined as activation of one or more of the following T cell markers: HLA-DR, CD38, CD25, KI67, and CD69; activation is defined as an increase of 20% or more over baseline in percentage of T cells expressing the marker. Comparison to be made between tissue biopsy taken following chemotherapy (and prior to antibiotics and pembrolizumab) and definitive surgical specimen.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- PROCEDURE Biopsy
- DRUG Metronidazole
- DRUG FOLFIRINOX
- DRUG Ciprofloxacin
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What NCT05462496 shows while recruiting
NCT05462496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05462496 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05462496 about?
NCT05462496 is a clinical study titled "Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer". A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
What is the current status of trial NCT05462496?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-03-16. Estimated completion is 2028-04.
What conditions does trial NCT05462496 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT05462496?
The interventions under investigation include: Pembrolizumab (DRUG), Biopsy (PROCEDURE), Metronidazole (DRUG), FOLFIRINOX (DRUG), Ciprofloxacin (DRUG).
Who is sponsoring clinical trial NCT05462496?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05462496 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05462496's enrollment target sits among peer trials
25 210th of 278 higher than 64 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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