NCT04729322View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic Colorectal AdenocarcinomaMetastatic Small Intestinal AdenocarcinomaStage IV Colorectal Cancer AJCC v8Stage IV Small Intestinal Adenocarcinoma AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8
Interventions
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

Trial Locations (1)

77030

M D Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER