# 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

> **NCT04729322** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **M.D. Anderson Cancer Center** · enrollment: 15 (actual)

## Conditions studied

- Metastatic Colorectal Adenocarcinoma
- Metastatic Small Intestinal Adenocarcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Small Intestinal Adenocarcinoma AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8

## Interventions

- **PROCEDURE:** Biopsy
- **PROCEDURE:** Fecal Microbiota Transplantation
- **DRUG:** Fecal Microbiota Transplantation Capsule
- **DRUG:** Metronidazole
- **DRUG:** Neomycin
- **BIOLOGICAL:** Nivolumab
- **BIOLOGICAL:** Pembrolizumab
- **OTHER:** Questionnaire Administration
- **DRUG:** Vancomycin

## Key facts

- **NCT ID:** NCT04729322
- **Lead sponsor:** M.D. Anderson Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-02-22
- **Primary completion:** 2027-12-31
- **Final completion:** 2027-12-31
- **Target enrollment:** 15 (ACTUAL)
- **Last updated:** 2025-12-23

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04729322

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04729322, "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". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT04729322. Licensed CC0.

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