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

Pilot Trial of Fecal Microbiota Transplantation and Re-Introduction of Anti-PD-1 Therapy in dMMR Colorectal Adenocarcinoma Anti-PD-1 Non-Responders

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of pembrolizumab or nivolumab in conjunction with fecal microbiota transplant (FMT) from PD-1 responding mismatch-repair deficiency (dMMR) colorectal cancer (CRC) patients for treatment of PD-1 non-responding dMMR CRC patient.

Conditions

• 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

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Fecal Microbiota Transplantation	Undergo colonoscopic FMT
DRUG	Fecal Microbiota Transplantation Capsule	Given PO
DRUG	Metronidazole	Given PO
DRUG	Neomycin	Given PO
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Vancomycin	Given PO

Timeline

• Start date: 2021-02-22
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-01-28
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study