RecruitingPhase 2NCT05462496

Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Neoadjuvant Checkpoint-based Immunotherapy Following Chemotherapy in Pancreatic Adenocarcinoma

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

25 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether modifying the gut microbiome — the community of trillions of bacteria living in your digestive system — using specific bacterial supplements before pembrolizumab immunotherapy can improve surgical outcomes for people with resectable pancreatic cancer after chemotherapy. Emerging research suggests gut bacteria influence how well immunotherapy works. **You may be eligible if...** - You have confirmed pancreatic adenocarcinoma (a specific type of pancreatic cancer, not a mixed histology) - Your cancer is considered potentially removable by surgery after chemotherapy - You have completed chemotherapy and are being evaluated for surgery **You may NOT be eligible if...** - Your pancreatic cancer is a non-adenocarcinoma histology - You have received prior immunotherapy or checkpoint inhibitor drugs - You have an autoimmune condition or are on immunosuppressive therapy - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Pre-treatment tumor biopsy

DRUGFOLFIRINOX

Patients will receive FOLFIRINOX chemotherapy every 2 weeks for 5 cycles. One cycle of mFOLFIRINOX = 14 days. Cycles of mFOLFIRINOX are delivered as follows\*: * Oxaliplatin: 85 mg/m2 IV over 2 hours on Day 1, followed by, * Irinotecan: 150 mg/m2 IV over 90 minutes on Day 1, followed by, * Leucovorin\*\*: 400 mg/m2 IV over 2 hours on Day 1, followed by, * 5FU: 2400 mg/m2 IV over 46-48 hours on Days 1-3

DRUGCiprofloxacin

Ciprofloxacin and metronidazole will be initiated 7 days following 5th dose of FOLFIRINOX. Subjects will self-administer ciprofloxacin 500mg PO BID on days 1-21. Participants will be instructed to take the antibiotics with food to minimize stomach upset and to administer at the same time each day. Treatment with antibiotics will continue for 21 days unless there is unacceptable toxicity or disease progression. Subjects will record date, time and number of tablets they take on provided drug diaries.

DRUGMetronidazole

Ciprofloxacin and metronidazole will be initiated 7 days following 5th dose of FOLFIRINOX. Subjects will self-administer metronidazole 500mg PO every 8 hours on days 1-21. Participants will be instructed to take the antibiotics with food to minimize stomach upset and to administer at the same time each day. Treatment with antibiotics will continue for 21 days unless there is unacceptable toxicity or disease progression. Subjects will record date, time and number of tablets they take on provided drug diaries.

DRUGPembrolizumab

Pembrolizumab will be initiated 7 days post initiation of antibiotics. Subjects will receive a flat dose of pembrolizumab 200mg IV over 30 minutes.

PROCEDURESurgical Resection

Following completion of 21 days of antibiotics, participant will undergo repeat imaging studies. If there is no progressive disease which renders participant surgically unresectable (based on NCCN guidelines 2.2021), subject will undergo definitive surgical resection.