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NCT04729322 · ClinicalTrials.gov registry record · Phase 2
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders
A Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04729322 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04729322, a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Colorectal Adenocarcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of fecal microbiota transplant and re-introduction of anti-PD-1 therapy (pembrolizumab or nivolumab) in treating anti-PD-1 non-responders with colorectal cancer that has spread to other places in the body (metastatic). Fecal microbiota transplants contain the normal bacteria and viruses found in fecal (stool) material. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab or nivolumab with fecal microbiota transplants may help to control the disease.
Conditions Studied
Interventions
- PROCEDURE Biopsy
- PROCEDURE Fecal Microbiota Transplantation
- DRUG Metronidazole
- DRUG Fecal Microbiota Transplantation Capsule
- DRUG Neomycin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04729322
The ClinicalTrials.gov registry entry for NCT04729322 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (86% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.
NCT04729322 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04729322 about?
NCT04729322 is a clinical study titled "Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders". This phase II trial studies the effect of fecal microbiota transplant and re-introduction of anti-PD-1 therapy (pembrolizumab or nivolumab) in treating anti-PD-1 non-responders with colorectal cancer that has spread to other places in the body (metastatic). Fecal microbiota transplants contain the n...
What is the current status of trial NCT04729322?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-02-22. Estimated completion is 2027-12-31.
What conditions does trial NCT04729322 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT04729322?
The interventions under investigation include: Biopsy (PROCEDURE), Fecal Microbiota Transplantation (PROCEDURE), Metronidazole (DRUG), Fecal Microbiota Transplantation Capsule (DRUG), Neomycin (DRUG).
Who is sponsoring clinical trial NCT04729322?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04729322 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.