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Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma

NCT03891979 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-06-26

No results posted yet for this study

Summary

A multi-institutional, single arm pilot study of antibiotics and pembrolizumab for the treatment of surgically resectable pancreatic cancer. The primary purpose of this study is to determine the change in immune activation in pancreatic tumor tissue following treatment with antibiotics and pembrolizumab.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be given for two doses every 3 weeks starting on day 8 (ie days 8 and 29). Antibiotics will continue throughout the entire four week pre-operative period. Ciprofloxacin 500mg PO BID days 1-29; Metronidazole 500mg PO TID days 1-29; Pembrolizumab 200mg IV days 8 and 29.

DRUG

Ciprofloxacin 500mg PO BID days 1-29

Antibiotics will continue throughout the entire four week pre-operative period.

DRUG

Metronidazole 500mg PO TID days 1-29

Antibiotics will continue throughout the entire four week pre-operative period.

Sponsors & Collaborators

Principal Investigators

  • Deidre Cohen · New York Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891979 on ClinicalTrials.gov